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Tamoxifen Citrate, Letrozole, Anastrozole, or Exemestane With or Without Chemotherapy in Treating Patients With Invasive RxPONDER Breast Cancer

CTO@hmc.psu.edu
Female
18 and over
Phase 3
This study is NOT accepting healthy volunteers
Hide eligibility criteria
Inclusion Criteria:

• Patients must have a histologically confirmed diagnosis of node positive (1-3 nodes) invasive breast carcinoma with positive estrogen and/or progesterone receptor status, and negative HER-2 status; estrogen and progesterone receptor positivity must be assessed according to American Society of Clinical Oncology (ASCO)/College of American Pathologists (CAP) guidelines as either estrogen receptor (ER) or progesterone receptor (PR) >= 1% positive nuclear staining; HER-2 test result negativity must be assessed as per ASCO/CAP 2013 guidelines using immunohistochemistry (IHC), in situ hybridization (ISH) or both; HER-2 is negative if a single test (or all tests) performed in a tumor specimen show: a) IHC negative (0 or 1+) or b) ISH negative using single probe or dual probe (average HER-2 copy number < 4.0 signals per cell by single probe or HER-2/CEP ration < 2.0 with an average copy number < 4.0 signals per cell by dual probe); if HER-2 IHC is 2+, evaluation for gene amplification (ISH) must be performed and the ISH must be negative; ISH is not required if IHC is 0 or 1+; HER-2 equivocal is not eligible
• Patients with multifocal, multicentric and synchronous bilateral breast cancers are allowed
• Multifocal disease is defined as more than one invasive cancer < 2 cm from the largest lesion within the same breast quadrant; (NOTE: the Oncotype DX testing must be completed on the largest lesion)
• Multicentric disease is defined as more than one invasive cancer >= 2 cm from the largest lesion within the same breast quadrant or more than one lesion in different quadrants (NOTE: Oncotype DX testing should be completed on all tumors and the determination for eligibility should be made on the highest recurrence score)
• Synchronous bilateral disease is defined as invasive breast cancer with positive lymph nodes (axillary or intramammary) in at least one breast, diagnosed within 30 days of each other; (NOTE: the Oncotype DX testing should be completed on both tumors and the tumor with the highest recurrence score should be used)
• Patients will have undergone axillary staging by sentinel node biopsy or axillary lymph nodes dissection (ALND); patients must have at least one, but no more than three known positive lymph nodes (pN1a, pN1b or pN1c); patients with micrometastases as the only nodal involvement (pN1mi) are not eligible; patients with positive sentinel node are not required to undergo full axillary lymph node dissection; this is at the discretion of the treating physician; axillary node evaluation is to be performed per the standard of care at each institution
• Patients must not have inflammatory breast cancer and must not have metastatic disease
• Patients with a prior diagnosis of contralateral ductal carcinoma in situ (DCIS) are eligible if they underwent a mastectomy or lumpectomy with whole breast radiation; prior partial breast irradiation, including brachytherapy, is not allowed; patients with a prior diagnosis of ipsilateral DCIS or invasive breast cancer who received radiation to that breast are not eligible
• Patients must have had either breast-conserving surgery with planned radiation therapy or total mastectomy (with or without planned postmastectomy radiation); patients must have clear margins from both invasive breast cancer and DCIS (as per local institutional guidelines); lobular carcinoma in situ (LCIS) at the margins is allowed
• Registration of patients who have not yet undergone Oncotype DX screening must occur no later than 56 days after definitive surgery; (for all patients, Step 2 Registration must occur within 84 days after definitive surgery); if the Oncotype DX Breast Cancer Assay has not been performed, patients must be willing to submit tissue samples for testing to determine the Recurrence Score value; a representative block or unstained sections from the representative block are sent directly to Genomic Health for Oncotype DX Breast Cancer Assay which will be performed according to the standard commercial process
• If the Oncotype DX Recurrence Score is already known and is 25 or less, the patient must be registered to Step 2 immediately following Step 1 registration; if the Oncotype DX Recurrence Score is already known and is greater than 25, the patient is ineligible
• Patients must have a complete history and physical examination within 28 days prior to registration
• Patients must have a performance status of 0-2 by Zubrod criteria
• Patients must be able to receive taxane and/or anthracycline based chemotherapy
• Patients must not have begun chemotherapy or endocrine therapy for their breast cancer prior to registration
• Patients must not require chronic treatment with systemic steroids (inhaled steroids are allowed) or other immunosuppressive agents
• Patients must not have received an aromatase inhibitor (AI) or a selective estrogen receptor modulator (SERM) such as tamoxifen or raloxifene within 5 years prior to registration
• Patients must not be pregnant or nursing; women of reproductive potential must have agreed to use an effective contraceptive method; a woman is considered to be of "reproductive potential" if she has had menses at any time in the preceding 12 consecutive months; in addition to routine contraceptive methods, "effective contraception" also includes heterosexual celibacy and surgery intended to prevent pregnancy (or with a side-effect of pregnancy prevention) defined as a hysterectomy, bilateral oophorectomy or bilateral tubal ligation; however, if at any point a previously celibate patient chooses to become heterosexually active during the time period for use of contraceptive measures outlined in the protocol, he/she is responsible for beginning contraceptive measures
• No other prior malignancy is allowed except for adequately treated basal cell (or squamous cell) skin cancer, in situ cervical cancer, or other cancer for which the patient has been disease-free for 5 years
• The Quality of Life and Economic Substudy is permanently closed to accrual effective 12/1/12; patients who consented to QOL prior to 12/1/12 should continue to complete QOL forms per their expectation report; patients who are able to complete a questionnaire in English must be offered the opportunity to participate in the Quality of Life and Economic Substudy; (The Quality of Life and Economic Substudy is available to U.S. INSTITUTIONS ONLY); patients who are not able to complete a questionnaire in English are registered to S1007 without participating in the Quality of Life and Economic Substudy
• Patients who consent to participate in the Quality of Life and Economic Substudy and who do not yet know the results of their Oncotype DX screening must agree to complete the S1007 Health-Related Quality of Life Questionnaire: Enrollment between 14 days prior to and 7 days after Step 1 Registration
• Patients who consent to participate in the Quality of Life and Economic Substudy and who do already know their Oncotype DX Recurrence Score (and it is 25 or less) will proceed to Step 2 Registration without completing the S1007 Health-Related Quality of Life Questionnaire Enrollment Form (but will complete the S1007 Health-Related Quality of Life Questionnaire: Randomized Study Form)
• Patients or their legally authorized representative must be informed of the investigational nature of this study and must sign and give written informed consent in accordance with institutional and federal guidelines; for Step 1 registration of patients who have not yet submitted specimens for the Oncotype DX Breast Cancer Assay, the appropriate consent form is the Step 1 Consent Form; for both Step 1 and Step 2 registration of patients whose Recurrence Score is already known and is 25 or less, the appropriate consent form is the Step 2 Consent Form
• As a part of the Oncology Patient Enrollment Network (OPEN) registration process the treating institution's identity is provided in order to ensure that the current (within 365 days) date of institutional review board approval for this study has been entered in the system
• STEP 2 REGISTRATION
• Recurrence score (RS) by Oncotype DX must be =< 25
• Step 2 Registration must take place within 84 days after definitive surgery; patients must not have begun chemotherapy or endocrine therapy for their breast cancer prior to randomization
• Patients randomized to either arm may also co-enroll in phase III trials that compare local therapies, or compare systemic therapies (such as chemotherapy, if randomized to Arm I of S1007)
• The Quality of Life and Economic Substudy is permanently closed to accrual effective 12/1/12; patients at U.S. INSTITUTIONS who consent to participate in the Quality of Life and Economic Substudy must agree to complete the S1007 Health-Related Quality of Life Questionnaire: Randomized Study Form after Recurrence Score results and randomized treatment status are known but before treatment has been initiated
• Patients or their legally authorized representative must be informed of the investigational nature of this study and must sign and give written informed consent in accordance with institutional and federal guidelines; for all patients the appropriate consent form for this registration is the Step 2 Consent
Show full eligibility criteria
NCT01272037
Drug: Anastrozole; Drug: Exemestane; Other: Laboratory Biomarker Analysis; Drug: Letrozole; Other: Quality-of-Life Assessment; Drug: Systemic Chemotherapy; Drug: Tamoxifen Citrate
Ductal Breast Carcinoma In Situ; Estrogen Receptor and/or Progesterone Receptor Positive; HER2/Neu Negative; Invasive Breast Carcinoma; Multicentric Breast Carcinoma; Multifocal Breast Carcinoma; Synchronous Bilateral Breast Carcinoma
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Selinexor (KPT-330) in Older Patients With Relapsed AML (SOPRA)

CTO@hmc.psu.edu
Male or Female
60 and over
Phase 2
This study is NOT accepting healthy volunteers
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Inclusion Criteria:

• Age = 60 years with relapsed/refractory AML of any type except for acute promyelocytic leukemia (APL; AML M3), after at least 1 prior AML therapy , who have never undergone, and who are not currently eligible for, stem cell transplantation, and are currently deemed unfit for intensive chemotherapy.
• ECOG = 2.
• Must have available archival or recently acquired bone marrow biopsy/aspiration or tumor tissue for central review to be eligible.
• Relapsed or refractory AML, defined as either: recurrence of disease after a complete remission (CR), or failure to achieve CR with initial therapy.
• Must have received at least 1 prior line of AML therapy given at standard doses and must have progressed after their most recent therapy. Prior therapy must have included: a hypomethylating agent with at least 2 cycles.
• At least 2 weeks must have elapsed since the last anti-leukemia treatment (with the exception of hydroxyurea) before first dose in this study.
Exclusion Criteria:

• Treatment with any investigational agent within 3 weeks prior to first dose in this study.
• Presence of central nervous system (CNS) leukemia.
• In blast transformation of chronic myeloid leukemia (CML). Prior myelodysplastic syndrome (MDS) is acceptable; prior treatment for MDS does not count as an AML therapy.
• Major surgery within 2 weeks of first dose of study drug. Patients must have recovered from the effects of any surgery performed greater than 2 weeks previously.
• Concurrent active malignancy under treatment.
• Known active hepatitis B virus (HBV) or C virus (HCV) infection; or known to be positive for HCV ribonucleic acid (RNA) or HBsAg (HBV surface antigen).
• Known HIV infection.
• Unable to swallow tablets, or patients with malabsorption syndrome, or any other disease significantly affecting gastrointestinal function.
• Patients whose AML is classified as favorable according to the European LeukemiaNet (ELN) disease risk assessment.
Show full eligibility criteria
NCT02088541
Drug: Hydroxyurea; Drug: Selinexor; Drug: Ara-C; Drug: azacitidine; Drug: Decitabine
Relapsed/Refractory Acute Myeloid Leukemia; Acute Myeloid Leukemia; AML; Karyopharm; Selinexor; KPT-330
Acute Myeloid Leukemia (AML)
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MRI and Gene Expression in Diagnosing Patients With Ductal Breast Cancer In Situ

Susann E. Schetter -CTO@hmc.psu.edu
Female
18 and over
N/A
This study is NOT accepting healthy volunteers
Hide eligibility criteria
Inclusion Criteria:

• Registration to Step 1:
• Patients must have pathologically confirmed diagnosis of unilateral ductal carcinoma in situ with no evidence of microinvasive or invasive disease obtained by core needle biopsy within 4 months of registration; patients diagnosed by surgical excision are not eligible; patients with synchronous bilateral disease are not eligible; patients with synchronous bilateral disease (i.e., synchronous DCIS or invasive cancer) are not eligible
• Patients will be staged prior to registration according to the clinical staging criteria adapted from the American Joint Committee on Cancer (AJCC) Cancer Staging Data Forms of the AJCC Cancer Staging Manual, 7th Edition, 2009; Note: For consistency purposes, AJCC 7th Edition will continue to be used throughout the entire study enrollment period
• Required studies include a bilateral screening mammogram within 6 months and diagnostic mammogram of the affected breast within 3 months prior to registration
• Patients must not have previous ipsilateral invasive breast cancer or DCIS
• Patients must not have known deleterious mutations in breast cancer (BRCA) genes
• Patients must not have received hormonal therapy (i.e., tamoxifen, raloxifene, and/or aromatase inhibitors) for prevention of breast cancer within 3 months of the biopsy documenting DCIS
• Patients must not have history of chemotherapy for cancer within 6 months prior to registration
• No prior history of breast radiotherapy that will prevent the use of radiotherapy for the present DCIS
• Patients must be judged to be suitable to undergo MRI and receive the contrast agent gadolinium (exclusions follow):
• No history of untreatable claustrophobia;
• No presence of metallic objects or implanted medical devices in body (i.e., cardiac pacemaker, aneurysm clips, surgical clips, prostheses, artificial hearts, valves with steel parts, metal fragments, shrapnel, tattoos near the eye, or steel implants);
• No history of sickle cell disease;
• No contraindication to intravenous contrast administration;
• No known allergy-like reaction to gadolinium or moderate or severe allergic reactions to one or more allergens as defined by the American College of Radiology (ACR); patient may be eligible if willing to undergo pre-treatment as defined by the institution's policy and/or ACR guidance;
• No findings consistent with renal failure, as determined by glomerular filtration rate (GFR) < 30 mL/min/1.73 m^2 based on a serum creatinine level obtained within 28 days prior to registration;
• Weight lower than that allowable by the MRI table;
• No prior MRI of the breasts within the 6 months prior to registration
• Patients must be eligible for breast-conserving therapy (BCT) based on clinical examination and mammography; if ultrasound is performed, findings must also be consistent with eligibility for BCT
• Patients must not have multicentric disease scheduled to undergo multiple lumpectomies; multifocal disease that can be encompassed in a single operative bed are eligible
• Women must not be pregnant or breast-feeding; all females of childbearing potential must have a blood test or urine study within 3 weeks prior to registration to rule out pregnancy; a female of childbearing potential is any woman, regardless of sexual orientation or whether they have undergone tubal ligation, who meets the following criteria:
• Has not undergone a hysterectomy or bilateral oophorectomy; or
• Has not been naturally postmenopausal for at least 24 consecutive months (i.e., has had menses at any time in the preceding 24 consecutive months)
• Women of childbearing potential must be strongly advised to use an accepted and effective method of contraception or to abstain from sexual intercourse for the duration of their participation in the study
• Registration to Step 2:
• MRI has been performed in Step 1, and additional imaging studies and biopsies performed if indicated
• The clinician/patient has made the decision as to whether the patient will proceed to wide local excision or mastectomy
• Registration to Step 3:
• Patient's most recent surgery was wide local excision with or without re-excision and for which there was obtained clear (>= 2 mm) margins at breast conserving surgery, and the pathology reveals pure DCIS; patients with invasive cancer or DCIS with microinvasion will not be registered on step 3, but will be followed for clinical outcomes
• The OncotypeDX Patient Report of the DCIS Score from the OncotypeDX Breast Cancer Assay performed by Genomic Health on the excision tissue have been uploaded by the site into the Rave electronic case report forms (eCRF)
Show full eligibility criteria
NCT02352883
Procedure: Magnetic Resonance Imaging; Procedure: Therapeutic Conventional Surgery; Procedure: Therapeutic Surgical Procedure; Radiation: Radiation Therapy; Drug: Endocrine Therapy; Other: Quality-of-Life Assessment; Other: Laboratory Biomarker Analysis; Other: Cytology Specimen Collection Procedure
Ductal Breast Carcinoma In Situ
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Genetic Testing in Screening Patients With Stage IB-IIIA Non-Small Cell Lung Cancer That Has Been or Will Be Removed by Surgery (The ALCHEMIST Screening Trial) (ALCHEMIST)

Chandra P. Belani -CTO@hmc.psu.edu
Chandra P. Belani -CTO@hmc.psu.edu
Male or Female
18 and over
N/A
This study is NOT accepting healthy volunteers
Hide eligibility criteria
Inclusion Criteria:

• PATIENT PRE-REGISTRATION ELIGIBILITY CRITERIA:
• For pre-surgical patients
• Suspected diagnosis of resectable non-small cell lung cancer; patients with squamous cell carcinoma are eligible only if the registering site has EA5142 institutional review board (IRB) approved
• Suspected clinical stage of IIIA, II or large IB (defined as size >= 4cm)
• For post-surgical patients
• Completely resected non-small cell lung cancer; patients with squamous cell carcinoma are eligible only if the registering site has EA5142 IRB approved
• Pathologic stage IIIA, II or IB (defined as size >= 4 cm)
• Eastern Cooperative Oncology Group (ECOG) performance status 0-1
• No patients who have received neoadjuvant therapy (chemo- or radio-therapy) for this lung cancer
• No prior or concurrent malignancies within 5 years, except non-melanoma skin carcinoma or in situ carcinomas; a secondary primary lung cancer is considered a concurrent malignancy and would make a patient ineligible for A151216
• No prior treatment with agents targeting EGFR mutation, ALK rearrangement, and PD-1/PD-L1/CTLA-4
• No patients known to be pregnant or lactating
• Patients who have had local genotyping are eligible, regardless of the local result
• No patients with recurrence of lung cancer after prior resection
• Note: Post-surgical patients should proceed to registration immediately following preregistration
• PATIENT REGISTRATION ELIGIBILITY CRITERIA:
• Completely resected NSCLC; patients with squamous cell carcinoma are eligible only if the registering site has EA5142 IRB approved
• Pathologic stage IIIA, II, or large IB (defined as size >= 4 cm)
• Tissue available for the required analyses
• In order to allow for time for central genotyping and eligibility for the ALCHEMIST treatment trial, patients must register within the following eligibility windows, depending on the adjuvant treatment approach:
• If no adjuvant therapy, register patient within 75 days following surgery
• If adjuvant chemotherapy only, register patient within 225 days following surgery
• If adjuvant chemotherapy and radiation, register patient within 285 days following surgery
Show full eligibility criteria
NCT02194738
Other: Cytology Specimen Collection Procedure; Other: Laboratory Biomarker Analysis
Large Cell Lung Carcinoma; Lung Adenocarcinoma; Stage IB Non-Small Cell Lung Carcinoma; Stage IB Squamous Cell Lung Carcinoma; Stage IIA Non-Small Cell Lung Carcinoma; Stage IIA Squamous Cell Lung Carcinoma; Stage IIB Non-Small Cell Lung Carcinoma; Stage IIB Squamous Cell Lung Carcinoma; Stage IIIA Non-Small Cell Lung Cancer; Stage IIIA Squamous Cell Lung Carcinoma
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Improving Outcomes in Cleft Palate Surgery

CTO@hmc.psu.edu
Male or Female
Not specified
N/A
This study is NOT accepting healthy volunteers
Hide eligibility criteria
Inclusion Criteria:
Active surgeon performing cleft palate repair in the US or Canada.
Exclusion Criteria:
Show full eligibility criteria
NCT02583100
Behavioral: Intensive Feedback; Behavioral: Routine Feedback
Cleft Palate
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Brentuximab Vedotin or Crizotinib and Combination Chemotherapy in Treating Patients With Newly Diagnosed Stage II-IV Anaplastic Large Cell Lymphoma

CTO@hmc.psu.edu
Male or Female
up to to 21 year(s) old
Phase 2
This study is NOT accepting healthy volunteers
Hide eligibility criteria
Inclusion Criteria:

• Newly diagnosed patients with histologically proven ALCL (International Classification of Diseases for Oncology [ICD-0] code: 9714/3)
• Disease must be cluster of differentiation (CD)30 positive
• Disease must be anaplastic lymphoma kinase (ALK) positive (defined by local institutional standards)
• Patients must have stage II, III, or IV disease
• Patients must have a life expectancy of >= 8 weeks
• Total bilirubin =< 1.5 x upper limit of normal (ULN) for age
• Alanine aminotransferase (ALT) (serum glutamate pyruvate transaminase [SGPT]) < 2.5 x upper limit of normal (ULN) for age; for the purpose of this study, the ULN for ALT is 45 U/L
• If the lab abnormality is thought to be due to the lymphoma the patient is eligible and dose adjustments should be made
• Shortening fraction of >= 27% by echocardiogram, or
• Ejection fraction of >= 50% by radionuclide angiogram
• Patients with a history of pulmonary dysfunction must have no evidence of dyspnea at rest, no exercise intolerance due to pulmonary insufficiency, and a pulse oximetry > 92% while breathing room air unless current dysfunction is due to the lymphoma in which case the patient is eligible
Exclusion Criteria:

• Patients with central nervous system (CNS) disease are not eligible
• Patients with disease limited to the skin are not eligible, regardless of how wide-spread
• Patients with stage I disease are not eligible
• Patients who have received any prior cytotoxic chemotherapy for the current diagnosis of ALCL or any cancer diagnosed previously are not eligible
• Previous steroid treatment and/or radiation treatment is not allowed unless it is for the emergent management of a mediastinal mass; emergent steroid treatment and/or radiation treatment should stop once protocol therapy is initiated
• Intrathecal chemotherapy prior to enrollment is allowed for the current diagnosis of ALCL as long as adequate cerebrospinal fluid (CSF) is obtained prior to administration of the intrathecal chemotherapy and subsequently demonstrated to be negative for ALCL
• Female patients who are pregnant are not eligible; pregnancy tests must be obtained in girls who are post menarchal
• Lactating females are not eligible unless they have agreed not to breastfeed their infants
• Sexually active patients of reproductive potential are not eligible unless they agree to use an effective contraceptive method for the duration of treatment and for 3 months after stopping treatment
• Patients with Down syndrome are not eligible
• Patients with an immunodeficiency that existed prior to diagnosis such as primary immunodeficiency syndromes or organ transplant recipients are not eligible
• Cytochrome P450, family 3, subfamily A, polypeptide 4 (CYP3A4) substrates with narrow therapeutic indices: Patients chronically receiving medications known to be metabolized by CYP3A4 and with narrow therapeutic indices including pimozide, aripiprazole, triazolam, ergotamine and halofantrine are not eligible; the topical use of these medications (if applicable) is allowed
• CYP3A4 inhibitors: patients chronically receiving drugs that are known potent CYP3A4 inhibitors within 7 days prior to study enrollment, including but not limited to ketoconazole, itraconazole, clarithromycin, erythromycin, ritonavir, indinavir, nelfinavir, saquinavir, delavirdine, nefazodone, diltiazem, verapamil, and grapefruit juice are not eligible; the topical use of these medications (if applicable), e.g. 2% ketoconazole cream, is allowed
• CYP3A4 inducers: patients chronically receiving drugs that are known potent CYP3A4 inducers within 12 days prior to study enrollment, including but not limited to carbamazepine, phenobarbital, phenytoin, rifabutin, rifampin, ritonavir, and St. John's wort are not eligible; the topical use of these medications (if applicable) is allowed
• Patients that are known to be positive for human immunodeficiency virus (HIV) are not eligible; note: inclusion of HIV positive patients will be considered at a later date
• Patients who weigh < 10 kg are not eligible
Show full eligibility criteria
NCT01979536
Drug: Brentuximab Vedotin; Drug: Crizotinib; Drug: Cyclophosphamide; Drug: Cytarabine; Drug: Dexamethasone; Drug: Doxorubicin Hydrochloride; Drug: Etoposide; Drug: Ifosfamide; Other: Laboratory Biomarker Analysis; Drug: Methotrexate
Stage II Childhood Anaplastic Large Cell Lymphoma; Stage III Childhood Anaplastic Large Cell Lymphoma; Stage IV Childhood Anaplastic Large Cell Lymphoma
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Combination Chemotherapy in Treating Young Patients With Newly Diagnosed High-Risk Acute Lymphoblastic Leukemia

Penn State Hershey Clinical Trials Office -cto@hmc.psu.edu
Male or Female
1 to 30 year(s) old
Phase 3
This study is NOT accepting healthy volunteers
Hide eligibility criteria
Inclusion Criteria:

• Patients must be enrolled on AALL08B1 prior to enrollment on AALL1131
• White Blood Cell Count (WBC) Criteria
• Age 1-9.99 years: WBC >= 50 000/uL
• Age 10-30.99 years: Any WBC
• Age 1-30.99 years: Any WBC with:
• Testicular leukemia
• CNS leukemia (CNS3)
• Steroid pretreatment
• Patients must have newly diagnosed B lymphoblastic leukemia (2008 World Health Organization [WHO] classification) (also termed B-precursor acute lymphoblastic leukemia); patients with Down syndrome are also eligible
• Eligibility criteria for the Incidence and Natural History of Osteonecrosis study
• Patients must be 10 years of age or greater at the time of B-ALL diagnosis, enrolled on AALL1131
• Patients with Down syndrome are not eligible
• Eligibility criteria for the Longitudinal, Computerized Assessment of Neurocognitive Functioning study
• Patients must be aged 6 to 11 years at time of B-ALL diagnosis, enrolled on AALL1131
• Patients must be English-, French- or Spanish-speaking (languages in which the assessment is available)
• Patients must have no known history of neurodevelopmental disorder prior to diagnosis of B-ALL (e.g., Down syndrome, Fragile X, William's Syndrome, mental retardation)
• Patients must have no significant visual impairment that would prevent computer use and recognition of the visual test stimuli
• Eligibility criteria for the National Cancer Institute (NCI) standard risk patients from AALL0932 enrolling on this study at the end of Induction:
• Patients enrolled on AALL0932, without Down syndrome, meeting the following criteria will NOT be eligible to continue on AALL0932 but WILL BE eligible to enroll on the HR B-ALL stratum of this study at the end of Induction:
• Without favorable cytogenetics (no ETV6-RUNX1 or double trisomies 4+10), with day 8 peripheral blood (PB) minimal residual disease (MRD) >= 1% and day 29 BM MRD < 0.01%
• With favorable cytogenetics (ETV6-RUNX1 or double trisomies 4+10), with any day 8 PB MRD and day 29 bone marrow (BM) MRD >= 0.01%
• Both NCI standard risk (SR) and HR patients without Down syndrome and with testicular disease at diagnosis, who do not meet other VHR criteria, will be eligible for the HR stratum
• Patients enrolled on AALL0932, without Down syndrome, meeting the following criteria will NOT be eligible to continue on AALL0932 but WILL BE eligible to enroll on the VHR B-ALL stratum of this study at the end of Induction:
• Intrachromosomal amplification of chromosome 21 (iAMP21)
• Mixed-lineage leukemia (MLL) rearrangement
• Hypodiploidy (n < 44 chromosomes and/or a deoxyribonucleic acid [DNA] index < 0.81)
• Induction failure (M3 BM at day 29)
• Without favorable cytogenetics (no ETV6-RUNX1 or double trisomies 4+10), with day 29 BM MRD >= 0.01%
• Patients enrolled on AALL0932, with Down syndrome, meeting the following criteria will NOT be eligible to continue on AALL0932 but WILL BE eligible to enroll on the DS HR B-ALL stratum of this study at the end of Induction:
• Day 29 MRD >= 0.01%
• MLL rearrangement
• Hypodiploidy (n < 45 chromosomes and/or DNA index < 0.81)
• DS HR B-ALL patients initially enrolled on AALL0932 or this study who have Induction failure (M3 BM day 29) or Philadelphia chromosome (BCR-ABL1) will not be eligible for post-Induction therapy on either trial (AALL0932 or AALL1131)
• All patients and/or their parents or legal guardians must sign a written informed consent
• All institutional, Food and Drug Administration (FDA), and NCI requirements for human studies must be met
Exclusion Criteria:

• With the exception of steroid pretreatment or the administration of intrathecal cytarabine, patients must not have received any prior cytotoxic chemotherapy for either the current diagnosis of B-ALL or any cancer diagnosed prior to the initiation of protocol therapy on AALL1131; patients cannot have secondary B-ALL that developed after treatment of a prior malignancy with cytotoxic chemotherapy; patients receiving prior steroid therapy may be eligible for AALL1131
• Patients with breakpoint cluster region (BCR)-v-abl Abelson murine leukemia viral oncogene homolog 1 (ABL1) fusion (not eligible for post-Induction therapy on this study; non-DS patients may be eligible to enroll in AALL1122 or successor Children's Oncology Group [COG] Philadelphia positive [Ph+] ALL trial by day 15 Induction)
• DS HR B-ALL patients with Induction failure or BCR-ABL1
• Female patients who are pregnant are ineligible
• Lactating females are not eligible unless they have agreed not to breastfeed their infant
• Female patients of childbearing potential are not eligible unless a negative pregnancy test result has been obtained
• Sexually active patients of reproductive potential are not eligible unless they have agreed to use an effective contraceptive method for the duration of their study participation
Show full eligibility criteria
NCT01406756
Drug: Clofarabine; Drug: Cyclophosphamide; Drug: Cytarabine; Drug: Dexamethasone; Drug: Doxorubicin Hydrochloride; Drug: Etoposide; Drug: Hydrocortisone Sodium Succinate; Other: Laboratory Biomarker Analysis; Drug: Leucovorin Calcium; Drug: Mercaptopurine; Drug: Methotrexate; Drug: Pegaspargase; Drug: Prednisone; Radiation: Radiation Therapy; Drug: Thioguanine; Drug: Vincristine Sulfate
B Acute Lymphoblastic Leukemia; Bone Necrosis; Central Nervous System Leukemia; Cognitive Side Effects of Cancer Therapy; Neurotoxicity Syndrome; Pain; Testicular Leukemia; Therapy-Related Toxicity; Untreated Adult Acute Lymphoblastic Leukemia; Untreated Childhood Acute Lymphoblastic Leukemia
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Combination Chemotherapy in Treating Patients With Non-Metastatic Extracranial Ewing Sarcoma

CTO@hmc.psu.edu
Male or Female
up to to 50 year(s) old
Phase 3
This study is NOT accepting healthy volunteers
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Inclusion Criteria:

• Patients with newly diagnosed, biopsy confirmed, extracranial, non-metastatic Ewing sarcoma or primitive neuroectodermal tumor (PNET) of bone or soft tissue are eligible for this study; note:
• For the purpose of this study, chest wall tumors with ipsilateral pleural effusions, ipsilateral positive pleural fluid cytology or ipsilateral pleural based secondary tumor nodules will be considered localized disease
• Patients with regional node involvement, based on clinical suspicion confirmed by pathologic documentation are considered to be non-metastatic
• Patients with discontinuous osseous lesions within the same bone are considered to be non-metastatic
• Tumors arising in the bony skull (extra-dural) are considered to be extracranial
• Patient eligibility will be based on a diagnosis of Ewing sarcoma or PNET by institutional pathologist
• No prior chemotherapy or radiation therapy is allowed; patients should only have had a biopsy of the primary tumor without an attempt at complete or partial resection; patients will still be eligible if unplanned excision was attempted or accomplished as long as adequate imaging was obtained prior to surgery
• Creatinine clearance or radioisotope glomerular filtration rate (GFR) >= 70mL/min/1.73 m^2 or serum creatinine based on age/gender as follows:
• 1 month to < 6 months: 0.4 mg/dL
• 6 months to < 1 year: 0.5 mg/dL
• 1 to < 2 years: 0.6 mg/dL
• 2 to < 6 years: 0.8 mg/dL
• 6 to < 10 years: 1 mg/dL
• 10 to < 13 years: 1.2 mg/dL
• 13 to < 16 years: 1.5 mg/dL (male), 1.4 mg/dL (female)
• >= 16 years: 1.7 mg/dL (male), 1.4 mg/dL (female)
• Total bilirubin < 1.5 x upper limit of normal (ULN) for age
• Serum glutamic oxaloacetic transaminase (SGOT) (aspartate aminotransferase [AST]) or serum glutamate pyruvate transaminase (SGPT) (alanine aminotransferase [ALT]) < 2.5 x upper limit of normal (ULN) for age
• Shortening fraction of >= 27% by echocardiogram, or ejection fraction of >= 50% by radionuclide angiogram
Exclusion Criteria:

• Patients must have no evidence of metastatic disease; metastatic disease:
• Are lesions which are discontinuous from the primary tumor, are not regional lymph nodes and do not share a body cavity with the primary tumor; if there is any doubt whether lesions are metastatic, a biopsy of those lesions should be taken
• Skeletal lesions in adjacent bones (trans-articular)
• Contralateral pleural effusion and contralateral pleural nodules
• Distant lymph node involvement
• Patients with pulmonary nodules are considered to have metastatic disease if the patient has:
• Solitary nodule > 0.5 cm or multiple nodules of > 0.3 cm unless biopsied and negative for Ewing's
• Biopsies of solitary nodule =< 0.5 cm or multiple nodules =< 0.3 cm are not required but if performed and positive indicate metastatic disease
• Patients whose tumors arise in the dural and intra-dural soft tissues of the cranium and spine are not eligible
• Patients with pathologic diagnoses other than Ewing sarcoma will be excluded
• Patients diagnosed with Ewing Sarcoma as a second malignant neoplasm are not eligible if they have received chemotherapy or radiation for the treatment of their primary malignancy
• Pregnant women will not be entered on this study; pregnancy tests must be obtained in female patients who are post-menarchal; lactating females may not participate unless they have agreed not to breastfeed their infants; males or females of reproductive potential may not participate unless they have agreed to use an effective contraceptive method for the duration of the study treatment
• All patients and/or their parents or legal guardians must sign a written informed consent
• All institutional, Food and Drug Administration (FDA), and National Cancer Institute (NCI) requirements for human studies must be met
Show full eligibility criteria
NCT01231906
Drug: vincristine sulfate; Drug: doxorubicin hydrochloride; Drug: cyclophosphamide; Drug: ifosfamide; Drug: etoposide; Drug: topotecan hydrochloride; Other: laboratory biomarker analysis
Adult Supratentorial Primitive Neuroectodermal Tumor (PNET); Childhood Supratentorial Primitive Neuroectodermal Tumor; Ewing Sarcoma of Bone; Extraosseous Ewing Sarcoma; Extraosseous Ewing Sarcoma/Peripheral Primitive Neuroectodermal Tumor; Localized Ewing Sarcoma/Peripheral Primitive Neuroectodermal Tumor; Peripheral Primitive Neuroectodermal Tumor of the Kidney; Untreated Childhood Supratentorial Primitive Neuroectodermal Tumor
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Biomarkers in Tumor Tissue Samples From Patients With Newly Diagnosed Neuroblastoma or Ganglioneuroblastoma

CTO@hmc.psu.edu
Male or Female
up to to 30 year(s) old
N/A
This study is NOT accepting healthy volunteers
Hide eligibility criteria
Inclusion Criteria:

• All newly diagnosed patients with suspected neuroblastoma, suspected ganglioneuroblastoma, or suspected ganglioneuroma/maturing subtype seen at Children's Oncology Group (COG) institutions are eligible for this study
• There will be no penalty under any circumstances for enrollment of a patient whose definitive institutional diagnosis, or central review diagnosis, is found to be a tumor other than neuroblastoma, ganglioneuroblastoma, or ganglioneuroma/ maturing subtype
• Patients may not have received chemotherapy prior to enrollment on ANBL00B1 and procurement of study-related tissues with the following exception:
• Patients that in the opinion of the treating physician are too ill to undergo pre-treatment tissue biopsy and require EMERGENT chemotherapy may be enrolled on ANBL00B1; documentation of the emergent nature of therapy initiation is required
• It is required that a good faith effort (documented by specimen tracking) be made to submit a neuroblastoma sample (tumor, metastasis, and/or tumor-involved bone marrow) of sufficient quality for MYCN analysis in the Neuroblastoma Reference Laboratory in order for any newly diagnosed patient to be enrolled on ANBL00B1; this should be obtained prior to initiation of therapy
• Exceptions
• In rare cases, patients may be deemed too ill to undergo pre-treatment tissue biopsy and require EMERGENT therapy; the following eligibility guidelines apply to these cases:
• For presumed INSS stage 4S patients: Efforts to submit tumor tissue (e.g., primary tumor, skin nodule, or metastatic site) within 96 hours of EMERGENT therapy initiation should be made; however, if the child is deemed too unstable for such a procedure they may still be enrolled as long as pre-treatment peripheral blood and serum have been submitted
• For all other INSS stages: tumor tissue should be obtained as soon as possible within 96 hours of EMERGENT therapy initiation; patients without tumor tissues submitted within this time-frame are not eligible for enrollment
• Note: it may not be possible to obtain all necessary tumor biomarkers for therapy stratification in such cases; if a patient enrolled on ANBL00B1 undergoes an additional diagnostic procedure within 96 hours of initiating therapy, additional tumor specimens may be submitted to obtain biomarkers used for risk classification; the decision to perform such procedures, and/or submit these specimens, is to be made by the managing clinicians and should reflect the clinical need to know the status of such biomarkers
• Patients enrolled on ANBL1232 in Group A (either A1 or A2) will not have a tumor biopsy or resection upfront; tumor tissue submission is therefore not required for these patients to enroll on ANBL00B1; a peripheral blood and serum sample is the only specimen required to be submitted for this group of patients; should they undergo a biopsy or resection at a later date tumor can be submitted for biomarker testing at this time
• All patients and/or their parents or legal guardians must sign a written informed consent
• All institutional, Food and Drug Administration (FDA), and National Cancer Institute (NCI) requirements for human studies must be met
Exclusion Criteria:

• Patients with relapsed neuroblastoma who were not enrolled on ANBL00B1 at original diagnosis are NOT eligible; samples should be submitted as part of the ABTR04B1 protocol
Show full eligibility criteria
NCT00904241
Other: laboratory biomarker analysis; Other: cytology specimen collection procedure
Disseminated Neuroblastoma; Ganglioneuroblastoma; Localized Resectable Neuroblastoma; Localized Unresectable Neuroblastoma; Regional Neuroblastoma; Stage 4S Neuroblastoma
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A Study of ICT-121 Dendritic Cell Vaccine in Recurrent Glioblastoma

CTO@hmc.psu.edu
Male or Female
18 and over
Phase 1
This study is NOT accepting healthy volunteers
Hide eligibility criteria
Inclusion Criteria:
1. Any recurrence of a glioblastoma multiforme 2. = 18 years of age 3. Human leukocyte antigen HLA A2 positive 4. Karnofsky Performance Score (KPS) of = 70% 5. Baseline hematologic studies and chemistry profiles must meet the following criteria:
• hemoglobin (Hgb) > 9.9 g/dL
• absolute neutrophil count (ANC) > 1000/mm3
• platelet count > 100,000/mm3
• blood urea nitrogen (BUN) < 30 mg/dL
• creatinine < 2 mg/dL
• alkaline phosphatase (ALP), aspartate aminotransferase (AST) and alanine aminotransferase (ALT) < 4x upper limit of normal (ULN)
• prothrombin time (PT) and activated partial thromboplastin time (PTT) = 1.6 x control unless therapeutically warranted 6. Female patients of child bearing potential must have negative serum pregnancy test 7. If not surgically sterile, male and female patients of childbearing age must use double barrier contraception (hormonal; intrauterine device; barrier) 8. Written informed consent, Release of Medical Records Form and HIPAA reviewed and signed by patient or legally authorized representatives 9. Ability to understand and the willingness to sign a written informed consent document. 10. Any Grade 3 or 4 toxicities (according to NCI CTCAE) resolved for at least 2 weeks prior to first treatment
Exclusion Criteria:
1. Radiosurgery including Gamma Knife, linear accelerator based radiosurgery, CyberKnife and placement of Gliadel wafer 2. Presence of any other active malignancy or prior history of malignancy, except for: basal cell carcinoma of the skin, cervical carcinoma in situ, early stage prostate carcinoma not requiring active treatment 3. New York Heart Association >/= Grade 3 congestive heart failure within 6 months prior to study entry 4. Uncontrolled or significant cardiovascular disease, including:
• Myocardial infarction and transient ischemic attack or stroke within 6 months prior to enrollment
• Uncontrolled angina within 6 months
• Diagnosed or suspected congenital long QT syndrome
• Any history of clinically significant ventricular arrhythmias (such as ventricular tachycardia, ventricular fibrillation, or Torsades de pointes);
• Clinically significant abnormality on electrocardiogram (ECG) 5. Pulmonary disease including or greater than grade 2 dyspnea or laryngeal edema, grade 3 pulmonary edema or pulmonary hypertension according to CTCAE 4.03 6. Severe acute or chronic medical or psychiatric condition that could increase the risk associated with trial participation or trial drug administration or could interfere with the interpretation of trial results and, in the judgment of the investigator, would make the patient inappropriate for entry into the trial. This includes but is not limited to the following: 1. Immunosuppressive disease 2. Chronic renal disease / failure 3. Concurrent neurodegenerative disease, 4. Dementia or significantly altered mental status that would prohibit the understanding or rendering of informed consent and compliance with the requirements of the protocol. 7. Presence of an acute infection requiring active treatment with antibiotics/antivirals; prophylactic administration is allowed 8. Known history of an autoimmune disorder 9. Known human immunodeficiency virus positivity or acquired immunodeficiency syndrome related illness or other serious medical condition 10. Breastfeeding 11. Received any other therapeutic investigational agent within 30 days of screening, except for immunotherapy. Patients with previous immunotherapy are not eligible regardless of timing. 12. Contraindication to MRI 13. Foreseeable condition which would preclude the reduction of steroids (dexamethasone) to a maximum of 2 mg BID within a week prior to apheresis -
Show full eligibility criteria
NCT02049489
Biological: ICT-121 DC vaccine
ICT-121; glioblastoma; immunotherapy; dendritic cell vaccine; CD133
Glioblastoma Multiforme
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Temozolomide With or Without Capecitabine in Treating Patients With Advanced Pancreatic Neuroendocrine Tumors

CTO@hmc.psu.edu
Male or Female
18 and over
Phase 2
This study is NOT accepting healthy volunteers
Hide eligibility criteria
Inclusion Criteria:

• Patient must have histologically or pathologically confirmed locally unresectable or metastatic low or intermediate grade pancreatic neuroendocrine tumor, excluding small cell carcinoma
• Patient must have measurable disease by Response Evaluation Criteria in Solid Tumors (RECIST) 1.1 criteria; baseline measurements and evaluations of all sites of disease must be obtained =< 4 weeks prior to randomization and must be acquired by multiphasic CT or contrast magnetic resonance imaging (MRI)
• Date of last documented disease progression must be =< 12 months from date of randomization
• Patient must not have received prior temozolomide, dacarbazine (DTIC), or capecitabine, or 5-FU (fluorouracil) therapy
• Prior everolimus and/or sunitinib therapy is allowed, so long as it was discontinued >= 4 weeks prior to randomization
• Concurrent somatostatin analogues are allowed provided that patients
• Have been on stable doses for 8 weeks and
• Have documented disease progression on that dose
• Patients may not be receiving any other investigational agents while on study treatment
• Patients may not be receiving Coumadin while on treatment; other anticoagulants are allowed
• Leukocytes >= 3,000/mm^3
• Absolute neutrophil count >= 1,500/mm^3
• Hemoglobin >= 9 g/dL
• Platelets >= 100,000/mm^3
• Total bilirubin =< institutional upper limit of normal (ULN) or =< 1.5 X institutional ULN (if the patient has liver metastases)
• Aspartate aminotransferase (AST) (serum glutamic oxaloacetic transaminase [SGOT])/alanine aminotransferase (ALT) (serum glutamate pyruvate transaminase [SGPT]) =< 3 X institutional ULN or (=< 5 X institutional ULN if the patient has liver metastases)
• Serum creatinine =< 1.5 X institutional ULN
• Patient must have Eastern Cooperative Oncology Group (ECOG) performance status 0-1
• Patient must have life expectancy >= 12 weeks
• Patients with either clinically apparent central nervous system metastases or carcinomatous meningitis are ineligible
• Patients must NOT have active or uncontrolled infection or serious medical or psychiatric illness
• Patients must NOT have history of allergic reactions attributed to compounds of similar chemical or biologic composition to temozolomide or capecitabine
• Patient must NOT have absorption issues that would limit the ability to absorb study agents
• Patients with a history of the following within =< 12 months of study entry are not eligible:
• Arterial thromboembolic events
• Unstable angina
• Myocardial Infarction
• Patients with symptomatic peripheral vascular disease are not eligible
• Patients must NOT have previous or concurrent malignancy; exceptions are made for patients who meet any of the following conditions:
• Non-melanoma skin cancer, in situ cervical cancer, or breast cancer in situ OR
• Prior malignancy completely excised or removed and patient has been continuously disease free for > 5 years OR
• Prior malignancy cured by non-surgical modalities and patient has been continuously disease free for > 5 years
• Women must not be pregnant or breast-feeding; all females of childbearing potential must have a blood test or urine study within =< 2 weeks prior to randomization to rule out pregnancy; a female of childbearing potential is any woman, regardless of sexual orientation or whether they have undergone tubal ligation, who meets the following criteria:
• Has not undergone a hysterectomy or bilateral oophorectomy; or
• Has not been naturally postmenopausal for at least 24 consecutive months (i.e., has had menses at any time in the preceding 24 consecutive months)
• Women of childbearing potential and sexually active males must be strongly advised to use an accepted and effective method of contraception or to abstain from sexual intercourse for the duration of their participation in the study; should a woman become pregnant while participating in this study, she should inform her treating physician immediately; if a man impregnates a woman while participating in this study, he should inform his treating physician immediately
• Patient must be able to swallow pills
• Patient must be able to tolerate CT or magnetic resonance (MR) imaging including contrast agents as required for their treatment and the protocol
Show full eligibility criteria
NCT01824875
Drug: temozolomide; Drug: capecitabine; Other: laboratory biomarker analysis
Gastrinoma; Glucagonoma; Insulinoma; Islet Cell Carcinoma; Pancreatic Polypeptide Tumor; Recurrent Islet Cell Carcinoma; Somatostatinoma
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Clofarabine or Daunorubicin Hydrochloride and Cytarabine Followed By Decitabine or Observation in Treating Older Patients With Newly Diagnosed Acute Myeloid Leukemia

David F. Claxton -CTO@hmc.psu.edu
David F. Claxton -CTO@hmc.psu.edu
David F. Claxton -CTO@hmc.psu.edu
Male or Female
60 and over
Phase 3
This study is NOT accepting healthy volunteers
Hide eligibility criteria
Inclusion Criteria:

• Sexually active males must be strongly advised to use an accepted and effective method of contraception
• Aspartate aminotransferase (AST), alanine aminotransferase (ALT) =< grade 1
• Total bilirubin =< grade 1
• Note: If total bilirubin is 2 to 3 mg/dL, but direct bilirubin is normal, then the patient will be considered eligible
• Patient must not have a concurrent active malignancy for which they are receiving treatment (other than myelodysplastic syndromes [MDS])
• Patient must not have an active, uncontrolled infection
• ADDITIONAL INDUCTION ELIGIBILITY CRITERIA:
• Newly-diagnosed AML patients according to World Health Organization (WHO) classification who are considered candidates for intensive chemotherapy based upon examination of peripheral blood or bone marrow aspirate specimens or touch preparations of the bone marrow biopsy obtained within two weeks prior to randomization; a bone marrow aspirate is required for enrollment; however, on occasion there is discordance between percentage of myeloblasts on the differential of the peripheral blood or aspirate; the peripheral blood criteria are sufficient for diagnosis; confirmatory immunophenotyping will be performed centrally
• NOTE: patients must be registered to E3903 (Ancillary Laboratory Protocol for the Collection of Diagnostic Material on Patients Considered for Eastern Cooperative Oncology Group (ECOG) Treatment Trials for Leukemia or Related Hematologic Disorders) and must undergo eligibility testing for the study by multiparameter flow cytometry
• NOTE: Southwest Oncology Group (SWOG)/Cancer Trials Support Unit (CTSU) institutions: E3903 is not open at the CTSU; therefore, baseline submissions must be submitted on E2906
• ECOG performance status (PS) 0-3 (restricted to ECOG PS 0-2 if >= 70 years of age)
• Patients with acute promyelocytic leukemia (APL) confirmed either by the presence of t(15;17)(q22;q21) or promyelocytic leukemia (PML)/retinoic acid receptor (RAR) alpha transcripts will be excluded
• Patients must not have blastic transformation of chronic myelogenous leukemia
• Patients with secondary AML are eligible for enrollment onto the trial; secondary AML is defined as AML that has developed in a person with a history of antecedent blood count abnormalities, or myelodysplastic syndrome (MDS), or a myeloproliferative disorder (excluding chronic myeloid leukemia); or a history of prior chemotherapy or radiation therapy for a disease other than AML
• NOTE: Prior therapy of MDS with decitabine, low-dose cytarabine, or azacitidine is excluded
• Patients may not have received prior chemotherapy for AML with the exception of hydroxyurea for increased blast count or leukapheresis for leukocytosis
• Total serum bilirubin =< 1.5 times upper limit of normal (ULN) (=< grade 1); if total bilirubin is 2 to 3 mg/dL, but direct bilirubin is normal, then the patient will be considered eligible
• Patients with a serum creatinine > 1 are eligible if they have a calculated glomerular filtration rate (GFR) of >= 60 ml/min (i.e. class I or class II chronic kidney disease ) using the Modification of Diet in Renal Disease (MDRD) formula
• Note: Daily creatinine and MDRD formula are only for the 1st induction cycle
• Cardiac ejection fraction >= 45% or within institutional normal limits; a nuclear medicine gated blood pool examination is preferred; a two-dimensional (2-D) echocardiogram (ECHO) scan is acceptable if a calculated ejection fraction is obtained and follow-up measurement of the cardiac ejection fraction will also be performed by echocardiography; measurement of cardiac ejection fraction should be within two weeks prior to receiving treatment
• NOTE: when a multi gated acquisition scan (MUGA) or echocardiogram cannot be obtained due to weekend or holiday, then patients may be enrolled provided there is no history of significant cardiovascular disease and a measurement of cardiac ejection fraction will be performed within 5 days of study enrollment
• Patients with suspected central nervous system (CNS) involvement should undergo lumbar puncture; those with documented CNS involvement will be excluded
• Cytogenetic analysis must be performed from diagnostic bone marrow (preferred) or if adequate number of circulating blasts (>10^9/l) from peripheral blood; this must be done via E3903
• NOTE: SWOG/CTSU institutions: E3903 is not open at the CTSU; therefore, baseline submissions must be submitted on E2906
• Patients who have received previous treatment for antecedent hematological disorders (AHD) with 5-azacitidine, decitabine, or low dose cytarabine will be excluded
• Patients with known human immunodeficiency virus (HIV) infection are excluded
• HLA typing should be performed at registration, if possible
• Diagnostic bone marrow and peripheral blood specimens must be submitted for immunophenotyping and selected molecular testing; this must be done via E2906
• NOTE: SWOG/CTSU institutions: E3903 is not open at the CTSU; therefore, baseline submissions must be submitted on E2906
• CONSOLIDATION CRITERIA:
• NOTE: All patients achieving CR or complete remission with incomplete blood count recovery (CRi) will receive consolidation when fit
• NOTE: Patients proceeding to transplant are allowed up to one cycle of consolidation treatment
• Consolidation cycle 1 must commence within sixty days of the bone marrow aspirate and biopsy that confirmed the presence of a CR or CRi
• Patients must have achieved a CR or CRi (or morphologic leukemia-free state for those patients proceeding to Arm G transplant)
• Patients who have achieved a CR or CRi must have maintained peripheral blood evidence of a CR or CRi
• Patients must have an ECOG performance status of 0-2
• Patients must have resolved any serious infectious complications related to induction
• NOTE: Patients with an HLA-matched donor and proceeding to transplant will be allowed up to one cycle of consolidation treatment
• Any significant medical complications related to induction must have resolved
• Patients must have a creatinine and AST =< grade 1
• MAINTENANCE CRITERIA:
• Maintenance should commence within 60 days of recovery of peripheral blood counts after consolidation cycle 2; patients must begin consolidation cycle 2 within 60 days of recovery to be eligible for further therapy
• Patients must have maintained peripheral blood evidence of a remission and must have a CR or CRi, confirmed on restaging bone marrow (BM) aspirate and biopsy and cytogenetic analysis
• Patients must have an ECOG performance status of 0 -2
• Patients must have resolved any serious infectious complications related to consolidation cycle 2
• Any significant medical complications related to consolidation cycle 2 must have resolved
• Total serum bilirubin =< 1.5 x ULN
• NOTE: if total bilirubin is 2-3 mg/dL, but direct bilirubin is normal, then the patient will be considered eligible
• Serum creatinine =< grade 1
• The absolute neutrophil count (ANC) must be > 1000 mm^3 prior to starting every cycle of treatment with decitabine; decitabine may be delayed for up to 4 weeks between cycles (i.e. may be administered as infrequently as every (q) 8 weeks) while waiting for counts to recover
• The platelet count must be > 75,000 mm^3 prior to starting every cycle of treatment with decitabine; decitabine may be delayed for up to 4 weeks between cycles (i.e. may be administered as infrequently as every (q) 8 weeks) while waiting for counts to recover
• ALLOGENEIC TRANSPLANTATION:
• Patients must be > 30 days and < 90 days from the start of induction or re-induction chemotherapy, or > 30 days and < 90 days of recovery from consolidation cycle 1 (if received), and must have achieved a response to induction therapy (CR, CRi, or "morphologic disease-free state", documented > 27 days after start of most-recent chemotherapy)
• Patients must have recovered from the effects of induction, re-induction, or consolidation chemotherapy (all toxicities =< grade I with the exception of reversible electrolyte abnormalities), and have no ongoing active infection requiring treatment
• Patients must have a total serum bilirubin =< 1.5 x ULN (grade =< 1) and a serum creatinine =< grade 1
• An eligible HLA-identical donor (either related or unrelated) should be available; in sibling donors, low resolution HLA typing (A,B,DR) will be considered sufficient; in the case of unrelated donors, high-resolution class I and II typing (A, B, C, DRB1 and DQ) should be matched at all 10 loci; donors must be willing and able to undergo peripheral blood progenitor mobilization
• HLA-identical sibling (6/6): the donor must be determined to be an HLA-identical sibling (6/6) by serologic typing for class (A, B) and low resolution molecular typing for class II (DRB1)
• Matched unrelated donor (10/10): high resolution molecular typing at the following loci is required: HLA-A, -B, -C, -DRBL, and -DQB1
• NOTE: for matched donors
•will allow select 1 antigen mismatched sibling donors and unrelated donors in accordance with site institutional standard, as long as matched at HLA-A, HLA-B, HLA-C, and DRB1, and with advanced discussion/approval by the Study Chair and the bone marrow transplant (BMT) co-chair
• Patients must be considered reliable enough to comply with the medication regimen and follow-up, and have social support necessary to allow this compliance
• Patients must have a cardiac ejection fraction of >= 40%, or within institutional normal limits; a nuclear medicine gated blood pool examination is preferred; a 2-D ECHO scan is acceptable if a calculated ejection fraction is obtained and follow-up measurement of the cardiac ejection fraction will also be performed by echocardiography; measurement of cardiac ejection fraction should be within two weeks prior to allogeneic transplantation
• Diffusion capacity of carbon monoxide (DLCO) > 40% with no symptomatic pulmonary disease
• No known hypersensitivity to Escherichia (E.) coli-derived products
• No human immunodeficiency virus (HIV) infection; patients with immune dysfunction are at a significantly higher risk of toxicities from intensive immunosuppressive therapies
• Creatinine =< grade 1
• Bilirubin =< grade 1
• If bilirubin is 2-3 mg/dL, but direct bilirubin is normal then patient will be considered eligible
• AST =< grade 1
Show full eligibility criteria
NCT02085408
Drug: clofarabine; Drug: daunorubicin hydrochloride; Other: clinical observation; Drug: cytarabine; Drug: decitabine; Other: laboratory biomarker analysis; Procedure: quality-of-life assessment; Other: questionnaire administration
Acute Myeloid Leukemia With Multilineage Dysplasia Following Myelodysplastic Syndrome; Adult Acute Megakaryoblastic Leukemia (M7); Adult Acute Minimally Differentiated Myeloid Leukemia (M0); Adult Acute Monoblastic Leukemia (M5a); Adult Acute Monocytic Leukemia (M5b); Adult Acute Myeloblastic Leukemia With Maturation (M2); Adult Acute Myeloblastic Leukemia Without Maturation (M1); Adult Acute Myeloid Leukemia With 11q23 (MLL) Abnormalities; Adult Acute Myeloid Leukemia With Del(5q); Adult Acute Myeloid Leukemia With Inv(16)(p13;q22); Adult Acute Myeloid Leukemia With t(16;16)(p13;q22); Adult Acute Myeloid Leukemia With t(8;21)(q22;q22); Adult Acute Myelomonocytic Leukemia (M4); Adult Erythroleukemia (M6a); Adult Pure Erythroid Leukemia (M6b); Secondary Acute Myeloid Leukemia; Untreated Adult Acute Myeloid Leukemia
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Rituximab and Bendamustine Hydrochloride, Rituximab and Ibrutinib, or Ibrutinib Alone in Treating Older Patients With Previously Untreated Chronic Lymphocytic Leukemia

CTO@hmc.psu.edu
Male or Female
65 and over
Phase 3
This study is NOT accepting healthy volunteers
Hide eligibility criteria
Inclusion Criteria:

• Patients must be diagnosed with CLL in accordance with International Workshop on Chronic Lymphocytic Leukemia (IWCLL) 2008 criteria that includes all of the following:
• >= 5 x 10^9 B lymphocytes (5000/uL) in the peripheral blood
• On morphologic review, the leukemic cells must be small mature lymphocytes, and prolymphocytes must not exceed 55% of the blood lymphocytes
• CLL cells on immunophenotype (performed locally) must reveal a clonal B-cell population, which express the B cell surface markers of cluster of differentiation (CD)19 and CD20, as well as the T-cell antigen CD5; patients with bright surface immunoglobulin expression or lack of CD23 expression in > 10% of cells must lack t(11;14) translocation by interphase cytogenetics
• Patients must be intermediate or high-risk Rai stage CLL
• Intermediate risk (formerly Rai stage I/II) is defined by lymphocytosis plus enlarged lymph nodes at any site, with or without hepatomegaly or splenomegaly
• High risk (formerly Rai stage III/IV) is defined by fulfilling criteria for intermediate risk disease plus disease-related anemia (hemoglobin < 11 g/dL) or thrombocytopenia (platelet count < 100 x 10^9/L) that is not attributable to autoimmune hemolytic anemia or thrombocytopenia
• Patients must meet criteria for treatment as defined by IWCLL 2008 guidelines which includes at least one of the following criteria:
• Evidence of marrow failure as manifested by the development or worsening of anemia or thrombocytopenia (not attributable to autoimmune hemolytic anemia or thrombocytopenia)
• Massive (>= 6 cm below the costal margin), progressive or symptomatic splenomegaly
• Massive nodes (>= 10 cm) or progressive or symptomatic lymphadenopathy
• Autoimmune anemia and/or thrombocytopenia that is poorly responsive to standard therapy
• Constitutional symptoms, which include any of the following:
• Unintentional weight loss of 10% or more within 6 months
• Significant fatigue
• Fevers > 100.5 degrees F for 2 weeks or more without evidence of infection
• Night sweats > 1 month without evidence of infection
• Prior treatment
• Patients must not have had prior therapy for CLL (except palliative steroids or treatment of autoimmune complications of CLL with rituximab or steroids)
• Treatment with rituximab and/or high dose corticosteroids for autoimmune complications of CLL must be complete at least 4 weeks prior to enrollment; palliative steroids must be at a dose not higher than 20 mg/day of prednisone or equivalent corticosteroid at the time of registration
• Eastern Cooperative Oncology Group (ECOG) performance status 0-2
• Patients with active hepatitis B defined by hepatitis B surface antigen positivity or core antibody positivity in the presence of hepatitis B DNA are not eligible for this study; patients with a positive hepatitis B core antibody but with negative hepatitis B DNA may participate, but must have hepatitis serologies and hepatitis B DNA monitored periodically by the treating physician
• Intravenous immunoglobulin (IVIG) can cause a false positive hepatitis B serology; if patients receiving routine IVIG have core antibody or surface antigen positivity without evidence of active viremia (negative hepatitis B DNA) they may still participate in the study, but should have hepatitis serologies and hepatitis B DNA monitored periodically by the treating physician
• Patients must not be receiving active systemic anticoagulation with heparin or warfarin; patients must be off warfarin therapy for at least 30 days prior to enrollment
• Patients with class III or class IV heart failure by New York Heart Association, those with unstable angina, and those with uncontrolled arrhythmia are not eligible
• Patients who have had a myocardial infarction, intracranial bleed, or stroke within the past 6 months are not eligible
• Patients with human immunodeficiency virus (HIV) are eligible if their CD4 count is >= 350 cells/mm^3 and if they are not taking prohibited cytochrome (CYP)-interacting medications
• Patients must not have any history of Richter's transformation or prolymphocytic leukemia (prolymphocytes in blood > 55%)
• Patients must not require more than 20 mg prednisone or equivalent corticosteroid daily
• Patients must not have uncontrolled active systemic infection requiring intravenous antibiotics
• Patients must not have continued requirement for therapy with a strong cytochrome P450 3A4/5 (CYP3A4/5) inhibitor or inducer
• Patients must not have a known allergy to mannitol
• Patients must not have prior significant hypersensitivity to rituximab (not including infusion reactions)
• Patients may not have had major surgery within 10 days of enrollment, or minor surgery within 7 days of enrollment; examples of minor surgery include dental surgery, insertion of a venous access device, skin biopsy, or aspiration of a joint; the decision about whether a surgery is major or minor can be made at the discretion of the treating physician
• Absolute neutrophil count (ANC) >= 1,000/uL unless due to bone marrow involvement
• Aspartate aminotransferase (AST) or alanine aminotransferase (AST) =< 2.5 x upper limits of normal except if due to disease infiltration of the liver
• Bilirubin =< 1.5 x upper limits of normal (unless due to liver involvement, hemolysis, or Gilbert's disease)
• Creatinine clearance >= 40 mL/min
• To be calculated by modified Cockcroft-Gault formula
• Platelet count (untransfused) >= 30,000/uL
Show full eligibility criteria
NCT01886872
Drug: Bendamustine Hydrochloride; Drug: Ibrutinib; Other: Laboratory Biomarker Analysis; Other: Quality-of-Life Assessment; Biological: Rituximab
Stage I Chronic Lymphocytic Leukemia; Stage II Chronic Lymphocytic Leukemia; Stage III Chronic Lymphocytic Leukemia; Stage IV Chronic Lymphocytic Leukemia
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Confirmatory Study of Eteplirsen in DMD Patients (PROMOVI)

Heidi Runk -hrunk@hmc.psu.edu
Male
7 to 16 year(s) old
Phase 3
This study is NOT accepting healthy volunteers
Hide eligibility criteria
Inclusion Criteria:

• Male 7-16 years old
• Diagnosed with DMD, genotypically confirmed
• Stable dose of corticosteroids for at least 6 months
• Have intact right and left alternative upper muscle groups
• Mean 6MWT greater than 300m (primary analysis on 300 to 450 meters)
• Stable pulmonary and cardiac function: predicted FVC equal to or greater than 50% and LVEF of greater than 50%
Exclusion Criteria:

• Previous treatment with drisapersen or any other RNA antisense agent or any gene therapy within the last 6 months
• Participation in any other DMD interventional clinical study within 12 weeks
• Major surgery within 3 months
• Presence of other clinically significant illness
• Major change in the physical therapy regime within 3 months Other inclusion/exclusion criteria apply.
Show full eligibility criteria
NCT02255552
Drug: eteplirsen
DMD, Duchenne, Eteplirsen, dystrophy, dystrophin, exon 51
Duchenne Muscular Dystrophy (DMD)
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Pomalidomide in Combination With Low-dose Dexamethasone or Pomalidomide in Combination With Low-dose Dexamethasone and Daratumumab in Subjects With Relapsed or Refractory Multiple Myeloma Following Lenalidomide-based Therapy in the First or Second Line Setting (POM MM 014)

CTO@hmc.psu.edu
Male or Female
18 and over
Phase 2
This study is NOT accepting healthy volunteers
Hide eligibility criteria
Inclusion Criteria:

•Subjects must satisfy the following criteria to be enrolled in the study: 1. Adults (age = 18 years at the time of signing the ICD) with documented diagnosis of MM and measurable disease (serum M-protein = 0.5 g/dL or urine M-protein = 200 mg/24 hours). 2. Subjects enrolling in Cohort A (Pom+LD-dex) must have received 2 prior treatment lines of anti-myeloma therapy. Subjects enrolling in Cohort B (Pom+Dara+LD-dex) must have received 1 or 2 prior treatment lines of anti-myeloma therapy. 3. All subjects must have received prior treatment with LEN or a LEN-containing regimen for at least 2 consecutive cycles as the most recent treatment regimen. 4. All subjects must have documented disease progression during or after their last antimyeloma therapy. 5. Subjects must have an Eastern Cooperative Oncology Group (ECOG) performance status score of 0, 1, or 2. 6. Subjects must understand and voluntarily sign an ICD prior to any study related assessments/procedures being conducted. 7. Subjects must be able to adhere to the study visit schedule and other protocol requirements. 8. All subjects must provide an adequate bone marrow sample at screening that definitively evaluates the presence or absence of myelodysplastic changes. 9. Females with child-bearing potential (FCBP†) must agree to use 2 reliable forms of contraception* simultaneously or practice complete abstinence from heterosexual contact for at least 28 days before starting study drug, while participating in the study (including during dose interruptions), and for at least 28 days after study treatment discontinuation and must agree to regular pregnancy testing during this timeframe. For subjects enrolled in Cohort B, pregnancy prevention and testing will continue until 3 months after last dose of daratumumab. 10. Females must agree to abstain from breastfeeding during study participation and 28 days after study drug discontinuation. Female subjects enrolled in Cohort B must agree to abstain from breastfeeding and donating eggs during study participation and until 3 months after last dose of daratumumab. 11. Males must agree to use a latex condom during any sexual contact with FCBP while participating in the study and for 28 days following discontinuation from this study, even if he has undergone a successful vasectomy. Male subjects enrolled in Cohort B must agree to use a latex condom during any sexual contact with FCBP while participating in the study and until 3 months after last dose of daratumumab. 12. Males must also agree to refrain from donating semen or sperm during the treatment phase and for 28 days after discontinuation from this study treatment. Male subjects enrolled in Cohort B must also agree to refrain from donating semen or sperm during the treatment phase and until 3 months after last dose of daratumumab. 13. All subjects must agree to refrain from donating blood while on study therapy and for 28 days after discontinuation from this study treatment. 14. All subjects must agree not to share medication.
Exclusion Criteria:
The presence of any of the following will exclude a subject from study enrollment: 1. Any of the following laboratory abnormalities:
• Absolute neutrophil count < 1,000/µL
• Platelet count < 75,000/µL for subjects in whom < 50% of bone marrow nucleated cells are plasma cells; or a platelet count < 30,000/µL for subjects in whom = 50% of bone marrow nucleated cells are plasma cells.
• Severe renal impairment (Creatinine Clearance [CrCl] < 30 mL/min) requiring dialysis.
• Corrected serum calcium > 11.5 mg/dL (> 2.8 mmol/L)
• Hemoglobin < 8 g/dL (< 4.9 mmol/L; prior red blood cell transfusion or recombinant human erythropoietin use is permitted)
• Serum SGOT/AST or SGPT/ALT > 3.0 x the upper limit of normal (ULN)
• Serum total bilirubin > 2.0 mg/dL (34.2 µmol/L); or > 3.0 x ULN for subjects with hereditary benign hyperbilirubinemia 2. Prior history of malignancies, other than MM, unless the subject has been free of the disease for = 5 years. Allowed exceptions include the following:
• Basal or squamous cell carcinoma of the skin
• Carcinoma in situ of the cervix or breast
• Incidental histological finding of prostate cancer (TNM [tumor, nodes, metastasis] stage of T1a or T1b) 3. Previous therapy with pomalidomide or daratumumab 4. Hypersensitivity to thalidomide, LEN, or dex (this includes = Grade 3 rash during prior thalidomide or LEN therapy) 5. Subjects who received an allogeneic bone marrow or allogeneic peripheral blood stem cell transplant less than 12 months prior to initiation of study treatment and who have not discontinued immunosuppressive treatment for at least 4 weeks prior to initiation of study treatment and are currently dependent on such treatment. 6. Subjects with any one of the following:
• Congestive heart failure (NY Heart Association Class III or IV)
• Myocardial infarction within 12 months prior to starting study treatment
• Unstable or poorly controlled angina pectoris, including Prinzmetal's variant angina pectoris 7. Subjects who received any of the following within 14 days of initiation of study treatment:
• Major surgery (kyphoplasty is not considered major surgery)
• Use of any anti-myeloma drug therapy 8. Use of any investigational agents within 28 days or 5 half-lives (whichever is longer) of treatment, unless approved by the sponsor. 9. Incidence of gastrointestinal disease that may significantly alter the absorption of Pomalidomide. 10. Subjects unable or unwilling to undergo antithrombotic prophylactic treatment 11. Any serious medical condition, laboratory abnormality, or psychiatric illness that would prevent the subject from signing the ICD 12. Pregnant or breastfeeding females 13. Known human immunodeficiency virus (HIV) positivity; active infectious hepatitis A, B, or C; or chronic hepatitis B or C 14. For subjects enrolling in Cohort B
•Subject has known allergies, hypersensitivity to mannitol, corticosteroids, monoclonal antibodies or human proteins, or their excipients (refer to the Daratumumab IB), or known sensitivity to mammalian-derived products.
Show full eligibility criteria
NCT01946477
Drug: Pomalidomide; Drug: Dexamethasone; Drug: Daratumumab
Multiple Myeloma, MM, cancer, oncology, hematology, plasma, neoplasm, plasmacytoma
Multiple Myeloma
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Outcomes Following Severe Distal Tibia, Ankle and/or Foot Trauma: Comparison of Limb Salvage Versus Transtibial Amputation Protocol (OUTLET)

CTO@hmc.psu.edu
Male or Female
18 to 60 year(s) old
N/A
This study is NOT accepting healthy volunteers
Hide eligibility criteria
Inclusion Criteria:
1. Patients with an injury that meets at least one of the following: 1. Gustilo type III pilon fractures consistent with one of the following OTA codes: 43B1.3, 43B2-B3, 43C, 44B, 44C 2. Gustilo type III B or C ankle fractures 3. Gustilo type III mid and/or hind foot fractures consistent with one of the following OTA codes: 81B2-B3, 82B and 82C 4. Open foot crush or blast injuries from high energy mechanism involving the mid and /or hind foot with significant soft tissues damage 5. Other severe foot injury (including closed foot crush or blast injuries) 2. Ages 18-60 inclusive. 3. Admitted to the hospital prior to definitive wound closure. Inclusion notes: 1. Patients may have other injuries except as noted below under exclusion criteria. 2. Foot crush and blast injuries are eligible if they are considered to be at significant risk for impaired outcome with moderate to severe disability and typically include one of the following associated injuries: 1. ankle dislocation (80A) 2. subtalar dislocation (80B) 3. extruded talus 4. chopart dislocation (80C) 5. multiple midfoot dislocations (80C) 6. three or greater proximal metatarsal fractures 7. heel pad/plantar degloving 8. extensive muscle necrosis in an open injury from crush, ischemia and/or foot compartment syndrome 3. These injuries may include "toe-pan" injuries from motor vehicle accidents and crush-like injuries from motorcycle accidents, and traumatic amputations.
Exclusion Criteria:
1. Patient has a Glasgow Coma Scale motor score of 0-4 or a Glasgow Coma Scale motor score of 5 with a significant traumatic brain injury (defined as an AIS code of 5 or 6) at time of consent 2. Patient has third degree burns on >10% total surface area affecting the study limb 3. Patient has a previous leg or foot amputation of either limb 4. Patient is non-ambulatory due to an associated complete spinal cord injury 5. Patient non-ambulatory pre-injury 6. Patient speaks neither English nor Spanish 7. Patient likely to have severe problems with maintaining follow- up due to at least one of the following: 1. Patient has been diagnosed with a severe psychiatric condition 2. Patient is intellectually challenged without adequate family support 3. Patient lives outside the hospital's catchment area 4. Follow-up is planned at another medical center 5. Patients who are prisoners or homeless
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NCT01606501
Severe Distal Tibia Injury; Severe Ankle Injury; Severe Foot Injury; Major Soft Tissue Loss; Major Bone Articular Surface Loss; Major Ankle Articular Surface Loss
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Study of IDO Inhibitor in Combination With Checkpoint Inhibitors for Adult Patients With Metastatic Melanoma

Becky Miller, BSN, RN, OCN -rmiller13@hmc.psu.edu
Male or Female
18 and over
Phase 1/Phase 2
This study is NOT accepting healthy volunteers
Hide eligibility criteria
Inclusion Criteria:

• Unresectable Stage III or Stage IV melanoma.
• Patients must have measurable disease, defined as lesions that can be accurately measure in in 2 perpendicular diameters with at least one diameter > 20mm and the other >10mm on conventional CT or MRI or 10mm x 10 mm by spiral CT.
• No systemic treatment in the previous 28 days.
• Age =18 years. Because no dosing or adverse event data are currently available on the use of ipilimumab or indoximod in patients <18 years of age, children are excluded from this study.
• ECOG performance status =2 (Karnofsky =60% )
• Patient has adequate bone marrow and organ function as defined by the following laboratory values :
• Absolute Neutrophil Count (ANC) = 1.0 x 109/L
• Platelets = 100 x 109/L
• Hemoglobin = 9.0 g/dL
• INR = 2 x ULN
• Potassium, calcium, magnesium = Grade 1 per CTCAE
• Serum Creatinine = 1.5 x ULN
• Serum Bilirubin, amylase and lipase = 1.5 x ULN (in patients with known Gilbert Syndrome, total bilirubin = 3 x ULN, with direct bilirubin = 1.5 x ULN)
• AST and ALT = 3 x ULN (or = 5.0 x ULN if hepatic metastases are present)
• Serum Albumin = 3 g/dL
• Patients must have normal pituitary function as defined below:
• free T4, TSH within normal institutional limits
• ACTH within normal institutional limits
• Patients with known brain metastases will only be eligible after their tumors have been treated with definitive resection and/or radiotherapy and they are neurologically stable for at least 1 month off steroids.
• The effects of indoximod on the developing human fetus are unknown. For this reason and because indoximod may affect maternal immune tolerance of the fetus, sexually active women of child-bearing potential must agree to use two forms of contraception (hormonal and barrier method of birth control or abstinence) prior to study entry and for the duration of study participation. Use of contraception or abstinence should continue for a minimum of 1 month after completion of the study. Should a woman become pregnant or suspect she is pregnant while participating in this study, she should discontinue the study drug and inform her treating physician immediately. A pregnancy test is required prior to study enrollment and monthly while on treatment with indoximod for all women of child-bearing potential. Also men should be discouraged from fathering children while on treatment.
• Ability to understand and the willingness to sign a written informed consent document.
Exclusion Criteria:

• Patients who have had molecular targeted therapy (including vemurafenib) or radiotherapy within 4 weeks prior to entering the study or those who have not recovered from adverse events due to agents administered more than 4 weeks earlier.
• Patients who have had prior therapy with immune checkpoint inhibition or or indoximod are excluded from the trial. Pre-treatment with other immune modulators is allowed in the phase 1 component of the study only. For the Phase II component, patients are excluded if they have had prior therapy with or immune-stimulating agents including interleukin-2, interferons, CTLA-4 or PD1 antagonists, CD40 or CD137 agonist, or cancer therapeutic vaccines in any prior line for metastatic disease. Interferons used in the adjuvant setting are allowed (Phase 1 or 2 component).
• Patients with known active, uncontrolled brain metastases should be excluded from this clinical trial.
• History of allergic reactions attributed to compounds of similar chemical or biologic composition to ipilimumab or tryptophan containing substances. This would include L-tryptophan or 5-hydroxy-tryptophan supplements. Also patients with a history of known hypersensitivity reactions to mouse or humanized monoclonal antibodies are excluded.
• Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection (especially toxoplasmosis, which could potentially be worsened by indoximod (Divanovic et al., 2012)), symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements.
• Pregnant women are excluded from this study because indoximod is an immunoregulatory agent with the potential for abortifacient effects due to fetal rejection by the maternal immune system. Because there is an unknown but potential risk for adverse events in nursing infants secondary to treatment of the mother with indoximod, breastfeeding should be discontinued if the mother is treated with indoximod.
• Known HIV-positive patients and those with other acquired/inherited immunodeficiencies are ineligible due the possibility of affecting the response to indoximod, and the higher risk of active opportunistic infections.
• Any other cancer, unless the patient has been disease-free for =5 years (except treated and cured basal-cell or squamous-cell skin cancer, superficial bladder cancer, or treated carcinoma in situ of the cervix, breast, or bladder and treated localized prostate cancer with undetectable PSA for 2 years).
• Patients with laboratory evidence of pancreatitis are excluded.
• Patients with autoimmune disease (e.g., psoriasis, extensive atopic dermatitis, asthma, IBD, M.S., uveitis, vasculitis), chronic inflammatory condition, or any condition requiring concurrent use of any systemic immunosuppressants or steroids for any reason are excluded from the study. Patients with isolated vitiligo remain eligible. Any patient with an allo-transplant of any kind would be excluded as well, including xenograft heart valve. Mild, intermittent asthma requiring only occasional beta-agonist inhaler use or mild localized eczema will not be excluded.
• Chronic use of immune-suppressive drugs (ie, systemic corticosteroids used in the management of cancer or non-cancer related illnesses, eg, COPD).
• Patients who are receiving any other investigational agent.
Show full eligibility criteria
NCT02073123
Drug: Indoximod; Drug: Ipilimumab; Drug: Nivolumab; Drug: Pembrolizumab
Metastatic melanoma; Stage III melanoma; Stage IV melanoma; unresectable
Metastatic Melanoma; Stage III Melanoma; Stage IV Melanoma
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Efficacy and Safety Doxorubicin Transdrug Study in Patients Suffering From Advanced Hepatocellular Carcinoma (ReLive)

CTO@hmc.psu.edu
Male or Female
18 and over
Phase 3
This study is NOT accepting healthy volunteers
Hide eligibility criteria
Inclusion Criteria:

• Male or non-pregnant, non-breast feeding female;
• Aged = 18 years;
• Patient with:
• advanced HCC (BCLC-C according to BCLC staging classification) having progressed under Sorafenib therapy or intolerant to Sorafenib, or;
• intermediate HCC (BCLC-B) non eligible or non responders to transarterial chemoembolization (TACE), and having progressed under or intolerant to Sorafenib therapy
• Patients with porta hepatis lymph nodes, extrahepatic metastases, or portal/suprahepatic vein thrombosis without extension in inferior/superior vena cava, are eligible;
• HCC diagnosed according to the AASLD and/or EASL criteria:
• Radiological Criteria applicable in cirrhotic liver:
• Nodule = 10 mm: one imaging technique among MRI and CT-scan showing typical appearances for HCC defined as arterial enhancement and rapid washout in portal venous or delayed phase;
• If appearance not typical for HCC on initial imaging: second contrast enhanced study (CT or MRI) showing typical appearances for HCC defined as arterial enhancement and rapid wash-out in portal venous or delayed phase;
• And/Or cyto-histology criteria (e.g. in case of atypical lesions for HCC at imaging, absence of cirrhosis);
• Without cirrhosis or with a non decompensated cirrhosis (Child-Pugh score from A5 to B7 included);
• ECOG Performance Status 0 or 1;
• Laboratory tests as follows:
• Platelets = 50,000 /mm3
• Neutrophil count = 1000/mm3
• Hemoglobin = 10g/dL
• Serum transaminases < 5 ULN (NCI/CTC grades 0, 1, or 2)
• Alkaline phosphatases < 5 ULN (NCI/CTC grades 0, 1, or 2)
• Serum bilirubin < 35 µM/L (or 2.0 mg/dL);
• Signed and dated written informed consent form.
Exclusion Criteria:

• Cirrhosis with a Child-Pugh score B8-C15;
• Untreated chronic hepatitis B;
• Patients eligible for curative treatments (transplantation, surgical resection, percutaneous treatment);
• Patients eligible for palliative treatments with demonstrated efficacy: TACE, Sorafenib; Patients who failed to Sorafenib treatment or intolerant to sorafenib are eligible and can be included if Sorafenib has been stopped at least 2 weeks before randomization;
• Prior history of malignancy with the exception of adequately treated basal cell carcinoma or in situ cervical cancer in complete remission since five years at least;
• HCC developed on transplanted liver;
• HIV infection;
• Risk of variceal bleeding;
• SaO2 < 95%;
• Presence of a significant acute or chronic respiratory disease defined as NCI/CTCAE > grade 2;
• Presence of recent (< 6 months) or current cardiac failure (class III or IV NYHA classification), recent (< 6 months) acute coronary syndrome, clinically significant ECG abnormalities or recent (less than 6 months) acute vascular diseases (stroke, MI…);
• Prior cumulative dose of 300 mg/m² of doxorubicin or equivalent;
• Patients currently treated with immunosuppressive agents that cannot be stopped;
• Patients whose medical or surgical conditions are unstable and may not allow the study completion or compliance, and specially patients with uncontrolled diabetes;
• Uncontrolled systemic infection;
• Patients with a life expectancy of less than 2 months;
• Patients who have received an experimental drug in another clinical trial in the last 30 days prior to randomization in the present clinical trial;
• Women of child-bearing age who are unwilling or unable to use an effective contraception method during the study treatment period and for 6 months after the last administration of study drug, and their male partner(s) refusing to use a condom (if applicable);
• Men who are unwilling or unable to use a condom during the study treatment period and for 6 months after the last administration of study drug, and their female partner(s) refusing to use one of the appropriate effective contraception methods (if applicable);
• Patients unwilling or unable to comply with protocol requirements and scheduled visits.
Show full eligibility criteria
NCT01655693
Drug: Doxorubicin; Drug: Best Standard of Care; Drug: Doxorubicin
Intermediate/advanced hepatocellular carcinoma; After failure or intolerance to Sorafenib.
Carcinoma, Hepatocellular
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Males, Antioxidants, and Infertility Trial (MOXI)

Patsy Rawa -prawa@hmc.psu.edu
Male
18 and over
Phase 2
This study is NOT accepting healthy volunteers
Hide eligibility criteria
Inclusion Criteria:
Couple
• 12 or more months of infertility (primary or secondary)
• Heterosexual
• Cohabitating and able to have regular intercourse Male:
• = 18 years of age
• At least one abnormal semen parameter on a semen analysis within the past 6 months:
• Sperm concentration =15 Million/ml
• Total motility =40%
• Normal morphology (Kruger) =4%
• DNA fragmentation (SCSA, DNA fragmentation index) >25% Female:
• =18 years of age and =38 years of age
• For women = 35 years of age, evidence of normal ovarian reserve as assessed by menstrual cycle day 3 (+/-2 days) FSH =10 IU/L with estradiol = 70 pg/mL, AMH = 1.0 ng/mL, OR antral follicle count >10 within one year prior to study initiation.
• Evidence of at least one patent fallopian tube as determined by an hysterosalpingogram or laparoscopy showing at least one patent fallopian tube or a saline infusion sonogram showing spillage of contrast material
• Regular cycles defined as =25 days and =35 days in duration
• Evidence of ovulation including biphasic basal body temperatures, positive ovulation predictor kits, or progesterone level =3 ng/ml.
Exclusion Criteria:

• Couple:
• Previous sterilization procedures (vasectomy, tubal ligation). The prior procedure may affect study outcomes.
• Planning in vitro fertilization in the next 6 months Male:
• Sperm concentration < 5 million/mL on screening semen analysis
• Current use of a medication or drug that would affect reproductive function or metabolism (see Appendix C for list)
• Current multivitamin or herb use (requires 1 month wash-out)
• Current serious medical illnesses, such as cancer, heart disease, or cirrhosis
• Current use of anticoagulants
• Untreated hypothyroidism
• Uncontrolled diabetes mellitus Female:
• History of endometriosis
• Body mass index >35 kg/m2
• Currently pregnant
• History of polycystic ovarian syndrome
• Current serious medical illnesses, such as cancer, heart disease, or cirrhosis
• History of systemic chemotherapy or pelvic radiation
• Current use of a medication or drug that would affect reproductive function or metabolism
Show full eligibility criteria
NCT02421887
Drug: Antioxidant Supplement; Other: Placebo
Male Infertility
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Pharmacokinetics (PK) and Safety of Subgam®VF in Primary Immunodeficiency Diseases (SCIG03)

CTO@hmc.psu.edu
Male or Female
2 to 75 year(s) old
Phase 3
This study is NOT accepting healthy volunteers
Hide eligibility criteria
Inclusion criteria: 1. Aged between 2 and 75 years (at time of initial consent). 2. Body Mass Index (BMI) < 46 for adults (aged 16 years & older), & BMI < 28 for children. 3. Diagnosed with primary immunodeficiency disease e.g. common variable immunodeficiency, X-linked & autosomal forms of agammaglobulinaemia, hyper-IgM syndrome, Wiskott-Aldrich syndrome. 4. Currently receiving a licensed (or investigational stage III, IIIb) IGIV or SCIG and 1. IGIV dose is between 300 and 800 mg/kg/month. SCIG dose is between 110 & 300 mg/kg/week; 2. Dose is stable for at least the past three months (i.e. consistent mg/kg +/- 5%); 3. The infusion interval is every 21 or 28 days for IGIV & seven days for SCIG; 4. Has a documented trough level of = 6 g/L (600 mg/dL) on current IgG therapy. If not available can be obtained at the screening visit, Visit 1 (Week 0). 5. Female subjects who are (or become) sexually active must practice contraception by using a method of proven reliability for the duration of the study. 6. Females of child-bearing potential, (defined from the onset of menstruation to one year post menopause), must have a negative result on a urine HCG-based pregnancy test. 7. Willing to comply with all aspects of the protocol, including blood sampling, for the duration of the study. 8. Signed an informed consent form. In the case of subjects under the legal age the parent/guardian will sign an informed consent form & where appropriate the subject will sign an assent form.
Exclusion Criteria:
1. Has a history of any severe anaphylactic reaction to blood or any blood-derived product. 2. Has selective IgA deficiency or has a history of antibodies to IgA. 3. Has clinically significant impairment of cellular or innate immunity at the discretion of the Investigator 4. Has evidence of an active infection at the time of enrolment (i.e. on day of first infusion). Subjects who are asymptomatic but have not completed their course of antibiotics are eligible. 5. Has previously completed or withdrawn from this study. 6. Is currently receiving, or has received, any investigational agent within the prior three months, unless it is an investigational stage III, IIIb IGIV or SCIG. 7. Is pregnant (confirmed by a positive result on an HCG-based pregnancy test) or is nursing. 8. Is positive for any of the following at screening: • Serological test for HIV 1&2, HCV, or HBsAg 9. Has levels at screening greater than 2.5 times the upper limit of normal as defined at the central laboratory of any of the following:
• Alanine transaminase (ALT)
• Aspartate transaminase (AST) 10. Has severe renal impairment (defined as serum creatinine greater than two times the upper limit of normal or BUN greater than two times the upper limit of normal for the range of the laboratory doing the analysis); the subject is on dialysis; or has a history of acute renal failure. 11. Is known to abuse alcohol, opiates, psychotropic agents, or other chemicals or drugs, or has done so within the past 12 months. 12. Has a history of DVT, or thrombotic complications of IgG therapy, or a prior diagnosis of thrombophilia. 13. Suffers from any acute or chronic medical condition, (e.g. renal disease or predisposing conditions for renal disease, coronary artery disease, or protein losing state, proteinuria) that the Investigator feels may interfere with the conduct of the study. 14. Has an acquired medical condition, such as chronic lymphocytic leukemia, lymphoma, multiple myeloma, chronic or recurrent neutropenia (ANC < 1 x 109/L). 15. Is receiving the following medication:
• Steroids (long-term daily, > 0.15 mg of prednisone equivalent/kg/day). Requirement for short or intermittent courses of > 0.15mg/kg/day would not exclude a subject.
• Immunosuppressive drugs
• Immunomodulatory drugs 16. If = 18 years of age, has non-controlled arterial hypertension (systolic blood pressure > 160 mmHg &/or diastolic blood pressure > 100 mmHg). For younger subjects refer to current guidelines for diagnosis of blood pressure1. 17. Has anemia (hemoglobin < 10 g/dL) at screening. 18. Has severe dermatitis that would preclude sites for safe product administration.
Show full eligibility criteria
NCT01884311
Biological: Subgam
X-linked agammaglobulinaemia; Hyper-IgM Syndrome; Subcutaneous; Immunoglobulins; Primary Immune Deficiency Disorders; Common Variable Immunodeficiency
Primary Immune Deficiency Disorders; Common Variable Immunodeficiency; X-linked Agammaglobulinaemia; Hyperimmunoglobulin M Syndrome
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Comparison of the Skin Conductance Values and Patient Pain Scores During Minor Procedures in the ICU

Elizabeth Sinz, MD -esinz@hmc.psu.edu
Christie Mulvey -cmulvey@hmc.psu.edu
Male or Female
18 to 89 year(s) old
N/A
This study is NOT accepting healthy volunteers
Hide eligibility criteria
Inclusion Criteria
• Patients between the ages of 18-89 years (inclusive), in an adult ICU
• Patients admitted to the ICU who are able to communicate their pain and anxiety using a VAS
• Patients must be cooperative and not agitated.
• Planned to have a potentially painful procedure
Exclusion Criteria:

• Diagnosed neuropathic disease
• Use of neostigmine within the past 3 hours
• Use of regional anesthesia at the extremity where the device electrodes are placed
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NCT02276703
Device: Skin Conductance Monitor
Pain
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Oxidized Regenerated Cellulose to Decrease Vaginal Cuff Complications

Carrie A Hossler, MD -chossler@hmc.psu.edu
Female
20 to 80 year(s) old
N/A
This study is also accepting healthy volunteers
Hide eligibility criteria
Inclusion Criteria:

• female, ages 20-80, undergoing laparoscopic hysterectomy
Exclusion Criteria:

• malignant indications for hysterectomy
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NCT01584128
Vaginal Cuff Complications
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Lung-MAP: Biomarker-Targeted Second-Line Therapy in Treating Patients With Recurrent Stage IV Squamous Cell Lung Cancer

Chandra P. Belani -CTO@hmc.psu.edu
Male or Female
18 and over
Phase 2/Phase 3
This study is NOT accepting healthy volunteers
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Inclusion Criteria:

• SCREENING/PRE-SCREENING REGISTRATION:
• Patients must have pathologically proven squamous cell carcinoma (SCCA) cancer of the lung confirmed by tumor biopsy and/or fine-needle aspiration; disease must be stage IV SCCA, or recurrent; the primary diagnosis of SCCA should be established using the current World Health Organization (WHO)/International Association for the Study of Lung Cancer (IASLC)-classification of Thoracic Malignancies; the diagnosis is based on hematoxylin and eosin (H&E) stained slides with or without specific defined immunohistochemistry (IHC) characteristic (p40/p63 positive, transcription termination factor [TTF1] negative) if required for diagnosis; mixed histologies are not allowed
• Patients must either be eligible to be screened at progression on prior treatment or to be pre-screened prior to progression on current treatment; patients will either consent to the screening consent or the pre-screening consent, not both; these criteria are:
• Screening at progression on prior treatment: to be eligible for screening at progression, patients must have received at least one line of systemic therapy for any stage of disease (stages I-IV); at least one of these lines of therapy must have been a platinum-based chemotherapy regimen; patients must have progressed following the most recent line of therapy; for patients whose prior systemic therapy was for stage I-III disease only (i.e. patient has not received any treatment for stage IV disease), disease progression on platinum-based chemotherapy must have occurred within one year from the last date that patient received that therapy
• Pre-screening prior to progression on current treatment: to be eligible for pre-screening, current treatment must be for stage IV disease and patient must have received at least one dose of the current regimen; patients must have previously received or currently be receiving a platinum-based chemotherapy regimen; patients on first-line platinum-based treatment are eligible upon receiving Cycle 1, Day 1 infusion; Note: patients will not receive their sub-study assignment until they progress and the S1400 Notice of Progression is submitted
• Patients must have adequate tumor tissue available, defined as >= 20% tumor cells and >= 0.2 mm^3 tumor volume; the local interpreting pathologist must review and sign off on the S1400 Local Pathology Review Form prior to screening/pre-screening registration; patients must agree to have this tissue submitted to Foundation Medicine for common broad platform Clinical Laboratory Improvement Amendments (CLIA) biomarker profiling; if archival tumor material is exhausted, then a new fresh tumor biopsy that is formalin-fixed and paraffin-embedded (FFPE) must be obtained; a tumor block or FFPE slides 4-5 microns thick must be submitted; bone biopsies are not allowed; if FFPE slides are to be submitted, at least 12 unstained slides plus an H&E stained slide, or 13 unstained slides must be submitted; however it is strongly recommended that 20 FFPE slides be submitted; Note: previous next-generation deoxyribonucleic acid (DNA) sequencing (NGS) will be repeated if done outside this study for sub-study assignment
• Patients must not have a known epidermal growth factor receptor (EGFR) mutation or anaplastic lymphoma kinase (ALK) fusion
• Patients must have Zubrod performance status 0-1 documented within 28 days prior to screening/pre-screening registration
• Patients must also be offered participation in banking for future use of specimens
• Patients must be willing to provide prior smoking history as required on the S1400 Onstudy Form
• As a part of the Oncology Patient Enrollment Network (OPEN) registration process the treating institution's identity is provided in order to ensure that the current (within 365 days) date of institutional review board approval for this study has been entered in the system
• Patients must be informed of the investigational nature of this study and must sign and give written informed consent in accordance with institutional and federal guidelines
• SUB-STUDY REGISTRATION:
• Patients whose biomarker profiling results indicate the presence of an EGFR mutation or echinoderm microtubule-associated protein-like 4 (EML4)/ALK fusion are not eligible
• Patients must have progressed per RECIST 1.1 following the most recent line of therapy
• Patients must not have received any prior systemic therapy (systemic chemotherapy, immunotherapy or investigational drug) within 21 days prior to sub-study registration; patients must have recovered (=< grade 1) from any side effects of prior therapy; localized palliative radiation therapy is allowed for symptom management, provided treatment is completed >= 14 days prior to sub-study registration; all other types of radiation must be completed >= 28 days prior to sub-study registration
• Patients must have measurable disease documented by computed tomography (CT) or magnetic resonance imaging (MRI); the CT from a combined positron emission tomography (PET)/CT may be used to document only non-measurable disease unless it is of diagnostic quality; measurable disease must be assessed within 28 days prior to sub-study registration; pleural effusions, ascites and laboratory parameters are not acceptable as the only evidence of disease; non-measurable disease must be assessed within 42 days prior to sub-study registration; all disease must be assessed and documented on the Baseline Tumor Assessment Form; patients whose only measurable disease is within a previous radiation therapy port must demonstrate clearly progressive disease (in the opinion of the treating investigator) prior to registration
• Patients must have a CT or MRI scan of the brain to evaluate for central nervous system (CNS) disease within 42 days prior to sub-study registration; patient must not have leptomeningeal disease, spinal cord compression or brain metastases unless: (1) metastases have been locally treated and have remained clinically controlled and asymptomatic for at least 14 days following treatment, AND (2) patient has no residual neurological dysfunction and has been off corticosteroids for at least 1 day prior to sub-study registration
• Patient must have fully recovered from the effects of prior surgery at least 14 days prior to sub-study registration
• Patients must not be planning to receive any concurrent chemotherapy, immunotherapy, biologic or hormonal therapy for cancer treatment; concurrent use of hormones for non-cancer-related conditions (e.g., insulin for diabetes and hormone replacement therapy) is acceptable
• Absolute neutrophil count (ANC) >= 1,500/mcl obtained within 28 days prior to sub-study registration
• Platelet count >= 100,000 mcl obtained within 28 days prior to sub-study registration
• Hemoglobin >= 9 g/dL obtained within 28 days prior to sub-study registration
• Serum bilirubin =< institutional upper limit of normal (IULN) within 28 days prior to sub-study registration; for patients with liver metastases, bilirubin must be =< 5 x IULN
• Either alanine aminotransferase (ALT) or aspartate aminotransferase (AST) =< 2 x IULN within 28 days prior to sub-study registration (if both ALT and AST are done, both must be =< 2 IULN); for patients with liver metastases, either ALT or AST must be =< 5 x IULN (if both ALT and AST are done, both must be =< 5 x IULN)
• Serum creatinine =< the IULN OR measured or calculated creatinine clearance >= 50 mL/min using the following Cockcroft-Gault Formula within 28 days prior to sub-study registration
• Patients must have Zubrod performance status 0-1 documented within 28 days prior to sub-study registration
• Patients must not have any grade III/IV cardiac disease as defined by the New York Heart Association Criteria (i.e., patients with cardiac disease resulting in marked limitation of physical activity or resulting in inability to carry on any physical activity without discomfort), unstable angina pectoris, and myocardial infarction within 6 months, or serious uncontrolled cardiac arrhythmia
• Patients must not have documented evidence of acute hepatitis or have an active or uncontrolled infection
• Patients with a known history of human immunodeficiency virus (HIV) seropositivity must: 1) have undetectable viral load using standard HIV assays in clinical practice, 2) have cluster of differentiation (CD)4 count >= 400/mcL, 3) not require prophylaxis for any opportunistic infections (i.e., fungal, Mycobacterium avium complex [mAC], or pneumocystis jiroveci pneumonia [PCP] prophylaxis), and 4) not be newly diagnosed within 12 months prior to sub-study registration
• Prestudy history and physical exam must be obtained within 28 days prior to sub-study registration
• No other prior malignancy is allowed except for the following: adequately treated basal cell or squamous cell skin cancer, in situ cervical cancer, adequately treated stage I or II cancer from which the patient is currently in complete remission, or any other cancer from which the patient has been disease free for five years
• Patients must not be pregnant or nursing; women/men of reproductive potential must have agreed to use an effective contraceptive method; a woman is considered to be of "reproductive potential" if she has had menses at any time in the preceding 12 consecutive months; in addition to routine contraceptive methods, "effective contraception" also includes heterosexual celibacy and surgery intended to prevent pregnancy (or with a side-effect of pregnancy prevention) defined as a hysterectomy, bilateral oophorectomy or bilateral tubal ligation; however, if at any point a previously celibate patient chooses to become heterosexually active during the time period for use of contraceptive measures outlined in the protocol, he/she is responsible for beginning contraceptive measures
• As part of the OPEN registration process the treating institution's identity is provided in order to ensure that the current (within 365 days) date of institutional review board approval for this study has been entered into the system
• Patients with impaired decision-making capacity are eligible as long as their neurological or psychological condition does not preclude their safe participation in the study (e.g., tracking pill consumption and reporting adverse events to the investigator)
• Patients must be informed of the investigational nature of this study and must sign and give written informed consent in accordance with institutional and federal guidelines.
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NCT02154490
Drug: Docetaxel; Biological: Durvalumab; Drug: Erlotinib Hydrochloride; Drug: FGFR Inhibitor AZD4547; Biological: Ipilimumab; Other: Laboratory Biomarker Analysis; Biological: Nivolumab; Drug: Palbociclib; Biological: Rilotumumab; Drug: Taselisib
Recurrent Squamous Cell Lung Carcinoma; Stage IV Squamous Cell Lung Carcinoma
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Clofarabine or Daunorubicin Hydrochloride and Cytarabine Followed By Decitabine or Observation in Treating Older Patients With Newly Diagnosed Acute Myeloid Leukemia

Clinical Trials Office - Penn State Hershey Cancer Institute a -CTO@hmc.psu.edu
Male or Female
60 and over
Phase 3
This study is NOT accepting healthy volunteers
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DISEASE CHARACTERISTICS:
• Newly diagnosed acute myeloid leukemia (AML)
• Considered candidates for intensive chemotherapy based on examination of peripheral blood or bone marrow aspirate specimens or touch preparations of the bone marrow biopsy obtained within the past 2 weeks
• Bone marrow aspirate is required for enrollment, however, if there is discordance between percentage of myeloblasts on the differential of the peripheral blood or aspirate, the peripheral blood criteria are sufficient for diagnosis
• Patients with secondary AML (defined as AML that has developed in a person with a history of antecedent blood count abnormalities, myelodysplastic syndromes [MDS], or a myeloproliferative disorder [excluding chronic myeloid leukemia], or a history of prior chemotherapy or radiotherapy for a disease other than AML) are eligible
• Patients with acute promyelocytic leukemia (APL) confirmed either by the presence of t(15;17)(q22;q21) or PML/RAR transcripts will be excluded
• No blastic transformation of chronic myelogenous leukemia
• No documented CNS involvement
• Concurrent registration on ECOG-E3903 (Ancillary Laboratory Protocol for the Collecting of Diagnostic Samples from Patients With Leukemia or Related Hematologic Disorders Being Considered for ECOG Treatment Clinical Trials) required (except for patients participating at CTSU institutions; these patients are exempt from this requirement)
• Cytogenetic analysis must be performed from diagnostic bone marrow (preferred) or if adequate number of circulating blasts (>10^9/L) from peripheral blood
• Diagnostic bone marrow and peripheral blood specimens must be submitted for immunophenotyping and selected molecular testing
• Peripheral blood stem cell donor meeting 1 of the following criteria:
• HLA-identical sibling (6/6)
• Low-resolution HLA typing (A,B,DR) allowed
• Matched unrelated donor (10/10)
• High-resolution class I and II typing (A,B,C,DRB1 and DQ) should be matched at all 10 loci PATIENT CHARACTERISTICS:
• ECOG performance status (PS) 0-3 (ECOG PS 0-2 if = 70 years of age)
• AST and ALT = grade 1
• Total serum bilirubin = 1.5 times upper limit of normal (ULN) (= grade 1)
• Serum creatinine = 1 mg/dL (= grade 1)
• Cardiac ejection fraction = 45% by MUGA or 2-D ECHO
• Fertile patients must use effective contraception
• No concurrent active malignancy requiring treatment (other than MDS)
• No active, uncontrolled infection
• No known HIV infection PRIOR CONCURRENT THERAPY:
• See Disease Characteristics
• No prior chemotherapy for AML (except for hydroxyurea for increased blast count or leukapheresis for leukocytes)
• No prior treatment with azacitidine, decitabine, or low-dose cytarabine
Show full eligibility criteria
NCT01041703
Drug: clofarabine; Drug: cytarabine; Drug: daunorubicin hydrochloride; Drug: decitabine
untreated adult acute myeloid leukemia; secondary acute myeloid leukemia; adult acute minimally differentiated myeloid leukemia (M0); adult acute myeloblastic leukemia without maturation (M1); adult acute myeloblastic leukemia with maturation (M2); adult acute myelomonocytic leukemia (M4); adult acute monoblastic leukemia (M5a); adult acute monocytic leukemia (M5b); adult erythroleukemia (M6a); adult pure erythroid leukemia (M6b); adult acute megakaryoblastic leukemia (M7); adult acute myeloid leukemia with 11q23 (MLL) abnormalities; adult acute myeloid leukemia with del(5q); adult acute myeloid leukemia with inv(16)(p13;q22); adult acute myeloid leukemia with t(16;16)(p13;q22); adult acute myeloid leukemia with t(8;21)(q22;q22)
Leukemia
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PKUDOS: Phenylketonuria (PKU) Demographic, Outcomes, and Safety Registry (PKUDOS)

CTO@hmc.psu.edu
Male or Female
Not specified
N/A
This study is NOT accepting healthy volunteers
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PKUDOS Registry
Inclusion Criteria:

• Patient has confirmed diagnosis of PKU with hyperphenylalaninemia documented by a Phenylalanine level of greater than or equal to 360 umol/L (6 mg/dL)
• Patient has previously received Kuvan
• Patient is currently receiving Kuvan
• Patient intends to receive Kuvan therapy within 90 days of enrollment into the registry
• The Patient is being followed at a PKUDOS participating center
• Willing and able to provide written authorization or, if under the age of 18 years, provide written assent (if required) and written patient authorization by a parent or legal guardian
• Willing to provide personal health information
Exclusion Criteria:

• Patients are not eligible to participate in PKUDOS if they are participating in a BioMarin-sponsored clinical study of Kuvan
• Patients not previously treated with Kuvan and patients that are unwilling to begin Kuvan therapy within 90 days of entry into the registry PKU MOMS Subregistry
Inclusion Criteria:

• Willing to enroll in (or are already enrolled in) PKUDOS
• Agree to follow the standard of care for pregnant women with PKU in the United States (NIH, 200, NIH Consensus Statement)
• Agree to be followed by a hospital or PKU clinic offering the standard of care for maternal PKU
• Are within 10 weeks of their last menstrual period
Exclusion Criteria:

• Patients who have not adhered to the standard of care for pregnant women with PKU in the United States are not eligible to participate in PKU MOMS
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NCT00778206
Drug: Kuvan
Phenylketonuria; Hyperphenylalaninemia; PKU; Phenylalanine
Phenylketonuria; Hyperphenylalaninaemia
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Assessment of Fixation Strategies for Severe Open Tibia Fractures (FIXIT)

CTO@hmc.psu.edu
Male or Female
18 to 64 year(s) old
Phase 3
This study is NOT accepting healthy volunteers
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Inclusion Criteria:
1. All open tibia fractures meeting at least one of 1 the following criteria:
• Diaphyseal or metaphyseal Type IIIB (Gustilo IIIB Fractures are open fractures that require either a rotational or free flap for coverage of a soft tissue defect).
• Diaphyseal or metaphyseal Type IIIA where extensive contamination or muscle damage (e.g. all military injuries from IED) precludes nail/plate placement at first debridement.
• Diaphyseal or metaphyseal Type IIIA, where injury would have been classified as a IIIB, but because enough muscle was removed, the skin could be closed.
• Diaphyseal or metaphyseal Type IIIA, where after debridement, bone gap is greater than 1cm.
• Diaphyseal or metaphyseal Type IIIA, where fasciotomies were performed for impending or diagnosed compartment syndrome, and wounds could not be closed primarily (i.e. needs skin grafting). 2. Ages 18
•64 years inclusive 3. Study fracture is suitable for limb salvage using either a modern ring external fixator or internal fixation (internal fixation =locked intramedullary nail or plate). Inclusion notes: 1. Patients may have co-existing non-tibial infection, with or without antibiotic treatment. 2. Patients may have risk factors for infection including diabetes, immunosuppression from steroids or other medications, HIV, or other infections. 3. Patients may have a traumatic brain injury. 4. Patients may be treated initially with a temporary external fixator prior to randomization. 5. Patients may be treated initially at an outside institution prior to transfer to the study institution, as long as the definitive fixation was not performed prior to entrance into the study. 6. Patients with bilateral injuries that meet inclusion criteria may be included, but only the limb rated as "more severe" by the treating surgeon will be enrolled in the study. 7. Fractures may have a gap after debridement of any size, including no gap.
Exclusion Criteria:
1. Patients presenting with a traumatic amputation of the tibia 2. Patients already received definitive fixation with an IM nail, plate or ring fixator prior to study enrollment 3. Tibia already infected as diagnosed by a surgeon and currently receiving treatment for it 4. Patient speaks neither English nor Spanish 5. Patient is a prisoner 6. Patient has been diagnosed with a severe psychiatric condition 7. Patient is intellectually challenged without adequate family support 8. Patient lives outside the catchment area 9. Non-ambulatory patient due to an associated complete spinal cord injury 10. Non-ambulatory before the injury due to a pre-existing condition. 11. Complex pilon and plateau fractures. The study tibia fracture may have extension into the joint surface, but should primarily be a metaphyseal or diaphyseal fracture and not have an ipsilateral tibial plateau or pilon fracture.Contralateral tibial plateau and pilon fractures are allowed
Show full eligibility criteria
NCT01494519
Procedure: Surgery with an external ring fixator; Procedure: Definitive fixation with a locked IM nail or plate
External ring fixation; internal fixation; traumatic tibia fracture
Severe Open Fractures of the Tibia (Shin) Bone
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Study of Efficacy and Safety in Premenopausal Women With Hormone Receptor Positive, HER2-negative Advanced Breast Cancer (MONALEESA-7)

CTO@hmc.psu.edu
Female
18 to 59 year(s) old
Phase 3
This study is NOT accepting healthy volunteers
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Inclusion Criteria:

• Patient has advanced (locoregionally recurrent or metastatic) breast cancer not amenable to curative therapy
• Patient is premenopausal or perimenopausal at the time of study entry
• Patients who received (neo) adjuvant therapy for breast cancer are eligible
• Patient has a histologically and/or cytologically confirmed diagnosis of estrogen-receptor positive and/or progesterone receptor positive breast cancer
• Patient has HER2-negative breast cancer
• Patient must have either measurable disease or If no measurable disease is present, then at least one predominantly lytic bone lesion
• Patient has an Eastern Cooperative Oncology Group (ECOG) performance status 0 or 1
• Patient has adequate bone marrow and organ function
Exclusion Criteria:

• Patient who has received a prior CDK4/6 inhibitor
• Patient is postmenopausal
• Patients who currently have inflammatory breast cancer at screening.
• Patients who received any prior hormonal anti-cancer therapy for advanced breast cancer, except for = 14 days of tamoxifen or NSAI ± goserelin for advanced breast cancer prior to randomization.
• Patient has a concurrent malignancy or malignancy within 3 years of randomization, with the exception of adequately treated basal cell skin carcinoma, squamous cell skin carcinoma, non-melanomatous skin cancer or curatively resected cervical cancer.
• Patient with CNS metastases.
• Patient has active cardiac disease or a history of cardiac dysfunction
• Patient is currently using other antineoplastic agents
• Patient is pregnant or nursing or physiologically capable of becoming pregnant and not using highly effective contraception
Show full eligibility criteria
NCT02278120
Drug: LEE011; Drug: Tamoxifen; Drug: Letrozole; Drug: Anastrozole; Drug: Goserelin; Drug: LEE011 Placebo
HR-positive; HER2-negative; Advanced breast cancer; Letrozole; Anastrozole; Tamoxifen; Goserelin; CDK; CDK4; CDK6; CDK4/6; Phase III; ER-positive; PR-positive; Premenopausal
Advanced, Metastatic Breast Cancer
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Study of Efficacy and Safety of LEE011 in Men and Postmenopausal Women With Advanced Breast Cancer. (MONALEESA-3)

CTO@hmc.psu.edu
Male or Female
18 and over
Phase 3
This study is NOT accepting healthy volunteers
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Inclusion Criteria:
1. Patient is an adult male/female = 18 years old at the time of informed consent and has signed informed consent before any trial related activities and according to local guidelines. Female patients must be postmenopausal. 2. Patient has a histologically and/or cytologically confirmed diagnosis of estrogen-receptor positive and/or progesterone receptor positive breast cancer by local laboratory and has HER2-negative breast cancer. 3. Patient must have either measurable disease by RECIST 1.1 or at least one predominantly lytic bone lesion. 4. Patient has advanced (loco regionally recurrent not amenable to curative therapy, e.g. surgery and/or radiotherapy, or metastatic) breast cancer. Patients may be:
• newly diagnosed advanced/metastatic breast cancer, treatment naïve
• relapsed with documented evidence of relapse more than 12 months from completion of (neo)adjuvant endocrine therapy with no treatment for advanced/metastatic disease
• relapsed with documented evidence of relapse on or within 12 months from completion of (neo)adjuvant endocrine therapy with no treatment for advanced/metastatic disease
• relapsed with documented evidence of relapse more than 12 months from completion of adjuvant endocrine therapy and then subsequently progressed with documented evidence of progression after one line of endocrine therapy (with either an antiestrogen or an aromatase inhibitor) for advanced/metastatic disease
• newly diagnosed advanced/metastatic breast cancer at diagnosis that progressed with documented evidence of progression after one line of endocrine therapy (with either an antiestrogen or an aromatase inhibitor) 5. Patient has an Eastern Cooperative Oncology Group (ECOG) performance status 0 or 1 6. Patient has adequate bone marrow and organ function
Exclusion Criteria:
1. Patient with symptomatic visceral disease or any disease burden that makes the patient ineligible for endocrine therapy per the investigator's best judgment. 2. Patient has received prior treatment with chemotherapy (except for neoadjuvant/ adjuvant chemotherapy), fulvestrant or any CDK4/6 inhibitor. 3. Patient with inflammatory breast cancer at screening . 4. Patient with CNS involvement unless they are at least 4 weeks from prior therapy completion to starting the study treatment and have stable CNS tumor at the time of screening and not receiving steroids and/or enzyme inducing anti-epileptic medications for brain metastases 5. Clinically significant, uncontrolled heart disease and/or cardiac repolarization abnormality 6. Patient is currently receiving any of the following substances and cannot be discontinued 7 days prior to start the treatment:
• Known strong inducers or inhibitors of CYP3A4/5,
• That have a known risk to prolong the QT interval or induce Torsades de Pointes.
• Those have a narrow therapeutic window and are predominantly metabolized through CYP3A4/5.
• Herbal preparations/medications, dietary supplements.
Show full eligibility criteria
NCT02422615
Drug: Ribociclib; Drug: fulvestrant; Drug: Ribociclib placebo
HR-positive; HER2-negative; Advanced breast cancer; LEE011; ribociclib; fulvestrant; faslodex; CDK6; CDK4/6; CDK4/6 inhibitor; Phase III; ER-positive; PR-positive; CDK; CDK4; Postmenopausal; Men
Breast Neoplasms; Breast Diseases; Neoplasms; Neoplasms by Site; Fulvestrant; Antineoplastic Agents; Antineoplastic Agents, Hormonal; Estrogen Receptor Antagonists; Hormone Antagonists; Hormones, Hormone Substitutes, and Hormone Antagonists; Molecular Mechanisms of Pharmacological Action; Pharmacologic Actions; Therapeutic Use
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Pediatric Precision Laboratory Advanced Neuroblastoma Therapy (PEDS-PLAN)

Penn State Hershey Clinical Trials Office -cto@hmc.psu.edu
Male or Female
1 to 21 year(s) old
Phase 1
This study is NOT accepting healthy volunteers
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Inclusion Criteria:

• Diagnosis: Subjects must have a diagnosis of high-risk (defined in protocol) neuroblastoma or ganglioneuroblastoma (nodular or intermixed) verified by histology or demonstration of clumps of tumor cells in bone marrow with elevated urinary catecholamine metabolites.
• Subjects must be age = 21 years at initial diagnosis
• Subjects must not have had prior systemic therapy except for localized emergency radiation to sites of life-threatening or function-threatening disease and/or no more than 1 cycle of chemotherapy per a low or intermediate risk neuroblastoma regimen (as per P9641, A3961, ANBL0531, or similar) prior to determination of MYCN amplification status and histology.
• Specimens will be obtained only in a non-significant risk manner and not solely for the purpose of investigational testing.
• Adequate liver function must be demonstrated (defined in protocol)
• Subjects must have adequate renal function defined as a Serum creatinine based on age/gender (defined in protocol)
• Adequate Cardiac Function (defined in protocol)
• Ability to tolerate PBSC collection: No known contraindication to PBSC collection.
• A negative serum pregnancy test is required for female participants of child bearing potential (=13 years of age or after onset of menses)
• Both male and female post-pubertal study subjects need to agree to use one of the more effective birth control methods during treatment and for six months after treatment is stopped. These methods include total abstinence (no sex), oral contraceptives ("the pill"), an intrauterine device (IUD), levonorgestrol implants (Norplant), or medroxyprogesterone acetate injections (Depo-provera shots). If one of these cannot be used, contraceptive foam with a condom is recommended.
• Informed Consent: All subjects and/or legal guardians must sign informed written consent. Assent, when appropriate, will be obtained according to institutional guidelines
Exclusion Criteria:

• Subjects who are 12-18 months of age with INSS Stage 4 and all stage 3 subjects with favorable biologic features (ie, nonamplified MYCN, favorable pathology, and DNA index > 1) are not eligible.
• Lactating females are not eligible unless they have agreed not to breastfeed their infants.
• Subjects receiving any investigational drug concurrently.
• Subjects with any other medical condition, including but not limited to malabsorption syndromes, mental illness or substance abuse, deemed by the Investigator to be likely to interfere with the interpretation of the results or which would interfere with a subject's ability to sign or the legal guardian's ability to sign the informed consent, and subject's ability to cooperate and participate in the study
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NCT02559778
Drug: sorafenib; Drug: vorinostat; Drug: DFMO; Drug: lapatinib; Drug: bortezomib; Drug: crizotinib; Drug: dasatinib
Neuroblastoma
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Study of Nifurtimox to Treat Refractory or Relapsed Neuroblastoma or Medulloblastoma

Penn State Hershey Clinical Trials Office -cto@hmc.psu.edu
Male or Female
up to to 21 year(s) old
Phase 2
This study is NOT accepting healthy volunteers
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Inclusion Criteria:

• Age: 0-21 years at the time of diagnosis.
• Diagnosis: Histologic verification at either the time of original diagnosis or relapse of neuroblastoma or medulloblastoma.
• Disease Status: Refractory or first or multiple relapsed neuroblastoma, or medulloblastoma that has relapsed after, or is refractory to, a chemotherapy-containing treatment regimen.
• Measurable disease, including at least one of the following:
• Measurable tumor by CT or MRI
• For neuroblastoma patients only, a positive MIBG (MIBG not required if subject's neuroblastoma is previously determined to not uptake MIBG), abnormal urinary catecholamine levels, or positive bone marrow biopsy/aspirate.
• For medulloblastoma patients only, positive CSF cytology
• Current disease state must be one for which there is currently no known curative therapy.
• A negative urine pregnancy test is required for female participants of child bearing potential (=13 years of age).
• Organ Function Requirements Patients without bone marrow metastases must have an ANC > 500/µl and platelet count >50,000/µl.
• Patients must have adequate liver function as defined by AST or ALT <10x normal
• Informed Consent: All patients and/or legal guardians must sign informed written consent. Assent, when appropriate, will be obtained according to institutional guidelines
Exclusion Criteria:

• Life expectancy <2 months or Lansky score <50%
• Investigational Drugs: Patients who are currently receiving another investigational drug are excluded from participation.
• Anti-cancer Agents: Patients who are currently receiving other anticancer agents are not eligible. Patients must have fully recovered from the effects of prior chemotherapy, generally at least 3 weeks from the most recent administration (6 weeks for nitrosoureas).
• Infection: Patients who have an uncontrolled infection are not eligible until the infection is judged to be well controlled.
• Patients who, in the opinion of the investigator, may not be able to comply with the safety monitoring requirements of the study, or in whom compliance is likely to be suboptimal, should be excluded. Compensation for travel related expenses may be available
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NCT00601003
Drug: Nifurtimox; Drug: Cyclophosphamide; Drug: Topotecan
Neuroblastoma; Medulloblastoma
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