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Suggestions within category "Cancer"


101 Study Matches

A Phase 2 Study of the JAK1/JAK2 Inhibitor Ruxolitinib With Chemotherapy in Children With De Novo High-Risk CRLF2-Rearranged and/or JAK Pathway–Mutant Acute Lymphoblastic Leukemia

A study of the safety and efficacy of ruxolitinib with routine chemotherapy for children with leukemia with specific genetic changes.
Suzanne Treadway, MS, RN, CCRP at streadway@pennstatehealth.psu.edu or 717-531-3097
All
All
This study is NOT accepting healthy volunteers
NCT02723994
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Inclusion Criteria:
A diagnosis of leukemia, specifically de novo high B-ALL with eligible genetic changes.
Age must be greater than 1 year old and less than or equal to 21 years old at leukemia diagnosis.
Have completed an acceptable induction therapy either on study or by hospital standard of care.
Exclusion Criteria:
Had any other chemotherapy before induction therapy, with exceptions.
Down Syndrome.
Children's Health, Cancer
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Hershey, PA

A Phase I/II Study of Neratinib in Pediatric Patients with Relapsed/ Refractory Solid Tumors

Neratininb for childhood cancer that has returned or is not responding to previous therapy
Suzanne Treadway, MS, RN, CCRP at streadway@pennstatehealth.psu.edu or 717-531-3097
All
All
This study is NOT accepting healthy volunteers
NCT02932280
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Inclusion Criteria:
Age 3 to 21 Inclusive
Cancer that has returned or is not responding to previous therapy
Has failed at least one prior therapy
Exclusion Criteria:
Certain prior therapies
Children's Health, Cancer
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Hershey, PA

Women In Steady Exercise Research - Neoadjuvant Exercise Trial

The primary purpose of this pilot study is to determine whether breast cancer patients whom elect to undergo cardiotoxic neoadjuvant chemotherapy can be enrolled and retained in a 6 month at home aerobic exercise training study. Using a randomized controlled trial approach, we will examine the safety and efficacy of a well monitored moderate-to-high intensity aerobic training program completed at home in breast cancer patients receiving neoadjuvant chemotherapy. In addition to assessing safety and efficacy of the program, we will assess intervention effects on cardiopulmonary fitness, cardiac function, and tumor response.
Kathleen Sturgeon at kms99@psu.edu or 717-531-0003, ext=284676
Female
18 year(s) or older
This study is NOT accepting healthy volunteers
N/A
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Inclusion Criteria:
Stage 1-3 breast cancer
Scheduled to start neoadjuvant chemotherapy
Sedentary
No heart disease
Exclusion Criteria:
Stage 4 breast cancer
Heart disease
Non-English speaking
Cancer
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Greater Philadelphia Area, PA
Harrisburg, PA
Hershey, PA

Single Arm Phase Ib/II Study of Durvalumab and Guadecitabine in Advanced Kidney Cancer: Big Ten Cancer Research Consortium (BTCRC-GU16-043) (PSCI 18-008)

This study is being done to test the safety of combining durvalumab with guadecitabine. It will also measure the percentage of patients whose tumor shrank after receiving durvalumab in combination with guadecitabine. Participants with kidney cancer that has spread to other parts of the body, also known as 'metastatic kidney cancer' will be recruited to participate.
All
18 year(s) or older
This study is NOT accepting healthy volunteers
NCT03308396
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Inclusion Criteria:
Histological diagnosis of clear cell renal cell carcinoma (pure or mixed) with radiologic or histologic evidence of metastatic disease
Prior cancer treatment must be completed at least 14 dats prior to study registration and the subject must have recovered from all reversible acute toxic effects of the regimen (other than alopecia) to Grade 1 or less baseline
ECOG Performance Status 0-1 within 28 days prior to registration
Demonstrate adequate organ function based on necessary screening labs to be obtained within 28 days prior to registration
Females of childbearing potential must have a negative serum pregnancy test within 28 days prior to registration
Exclusion Criteria:
Active infection requiring systemic therapy
Brain metastases or spinal cord compression
Pregnant or breastfeeding
Treatment with any investigational drug within 14 days prior to study registration
Current or prior use of immunosuppresive medication within 28 days before the first dose of durvalumab, with the exceptions of intranasal and inhaled corticosteroids or systemic corticosteroids at physiologic doses
Kidney & Urinary System, Cancer
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Hershey, PA

Site For 18-047, EA9152 Venetoclax (ABT-199) in Combination with Liposomal Vincristine in Patients with Relapsed or Refractory T-cell or B-cell ALL

Site For 18-047, EA9152 Venetoclax (ABT-199) in Combination with Liposomal Vincristine in Patients with Relapsed or Refractory T-cell or B-cell ALL
Lea Russell at PSCI-CTO@pennstatehealth.psu.edu or 717-531-5471
All
18 year(s) or older
This study is NOT accepting healthy volunteers
NCT03504644
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Inclusion Criteria:
Relapsed or refractory B-cell or T-cell ALL after multi-agent chemotherapy(≥ 5% marrow lymphoblasts, assessed by morphology and flow cytometry
ECOG performance status 0-2
Creatinine clearance of at least 50 mL/min within 7 days prior to first dose of study agent
Adequate liver function with AST/ALT less than 3X upper limit of normal and total bilirubin less than 2 mg/dL within 7 days prior to first dose of study agent
Circulating WBC count must not be above 20 x10^9/L within 7 days prior to first dose of study agent
Exclusion Criteria:
Pregnant or breast-feeding due to risk of fetal harm by the chemotherapeutic agents prescribed in this protocol
Evidence of isolated extramedullary relapse (i.e., testicular or CNS)
Serious medical or psychiatric illness that in the opinion of the primary investigator is likely to interfere with study participation may not be enrolled
Poorly controlled HIV, or CD4 < 400. HIV positive patients are allowed on this study if they have a CD4 count greater than or equal to 400, and are on a stable antiviral regimen
Patients with NYHA Class III or IV heart failure, uncontrolled angina, severe uncontrolled ventricular arrhythmias, or electrocardiographic evidence of acute ischemia may not be enrolled
Cancer
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Hershey, PA

Site for Cabazitaxel with Abiraterone versus Abiraterone alone Randomized Trial for Extensive Disease following Docetaxel: the CHAARTED2 Trial

To assess whether the addition of 6 cycles of cabazitaxel to abiraterone acetate in patients with CRPC that have previously received docetaxel and ADT for HSPC can improve PFS compared to abiraterone acetate alone.
Kathleen Rizzo at PSCI-CTO@pennstatehealth.psu.edu or 717-531-5471
All
18 year(s) or older
This study is NOT accepting healthy volunteers
NCT03419234
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Inclusion Criteria:
Age ≥ 18 years
Histologically confirmed diagnosis of prostate cancer (adenocarcinoma of the prostate).
Previous chemotherapy with at least 3 cycles of docetaxel for hormone-sensitive metastatic prostate cancer.
Metastatic disease as evidenced by the presence of soft tissue and/or bone metastases on imaging studies (CT/MRI of abdomen/pelvis, bone scintigraphy or NaF PET/CT).
Ability to swallow abiraterone acetate tablets as a whole.
Exclusion Criteria:
Any prior chemotherapy or AR-directed therapy for CRPC, (e.g. docetaxel, cabazitaxel, mitoxantrone, abiraterone
Pure small cell or other variant (non-adenocarcinoma) prostate cancer histology for which treatment with abiraterone would not be considered appropriate.
Patients may not be receiving other therapeutic investigational agents or be receiving concurrent anticancer therapy other than standard androgen deprivation therapy.
Any medical condition for which prednisone (corticosteroid) is contraindicated.
Active infection requiring treatment with antibiotics.
Cancer
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Hershey, PA

A phase III, multicenter, randomized, open-label trial to evaluate efficacy and safety of ribociclib with endocrine therapy as an adjuvant treatment in patients with hormone receptor-positive, HER2-negative, early breast cancer (New Adjuvant TriAl with Ribociclib [LEE011]: NATALEE).

This is a drug study that will examine the drug Ribociclib with endocrine therapy versus just endocrine therapy in patients with early breast cancer.
Kathleen Rizzo at krizzo@pennstatehealth.psu.edu
All
18 year(s) or older
This study is NOT accepting healthy volunteers
NCT03701334
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Inclusion Criteria:
Patient with histologically confirmed unilateral primary invasive adenocarcinoma of the breast with a date of initial cytologic or histologic diagnosis within 18 months prior to randomization
Patient has breast cancer that is positive for ER and/or PgR
Patient has HER2-negative breast cancer defined as a negative
Patient has available archival tumor tissue from the surgical specimen, for submission to a central laboratory.
If indicated, patient has completed adjuvant and/or neoadjuvant chemotherapy according to the institutional guidelines
Exclusion Criteria:
Patient has received any CDK4/6 inhibitor
Patient has received prior treatment with tamoxifen, raloxifene or AIs
Patient has received prior treatment with anthracyclines at cumulative doses of 450 mg/m² or more for doxorubicin, or 900 mg/m² or more for epirubicin.
h a known hypersensitivity to any of the excipients of ribociclib and/or ET (
Patient with distant metastases of breast cancer beyond regional lymph nodes
Cancer
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Hershey, PA

Site for EA9161: A Randomized Phase III Study of the addition of Venetoclax to Ibrutinib and Obinutuzumab versus Ibrutinib and Obinutuzumab in Untreated Younger Patients with Chronic Lymphocytic Leukemia (CLL)

The is a drug study to compare the progression free survival of the three drug combination Ibrutinib-Obinutuzumab-Venetoclax (IOV) to Ibrutinib-Obinutuzumab (IO) in untreated CLL patients younger than 70 years of age.
Michelle Stojanovic at PSCI-CTO@pennstatehealth.psu.edu or 717-531-5471
All
18 year(s) or older
This study is NOT accepting healthy volunteers
NCT03701282
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Inclusion Criteria:
Diagnosis of CLL according to the NCI/IWCLL criteria or SLL according to the WHO criteria
Negative FISH analysis for t(11;14)(IgH/CCND1) on peripheral blood or tissue biopsy
Age ≥ 18 years and < 70.
ECOG performance status between 0-2.
Life expectancy of ≥ 12 months.
Exclusion Criteria:
No deletion of 17p13 on cytogenetic analysis by FISH
No active hemolytic anemia requiring immunosuppressive therapy or other pharmacologic treatment.
No current use of corticosteroids.
No previous autoimmune complications
No other active primary malignancy
Cancer
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Hershey, PA

Site for A RANDOMIZED PHASE III DOUBLE BLINDED PLACEBO CONTROLLED TRIAL OF ASPIRIN AS ADJUVANT THERAPY FOR HER2 NEGATIVE BREAST CANCER: THE ABC TRIAL.

This is a drug study with a primary outcome of testing aspirin as therapy versus a placebo pill for patients for breast cancer.
Lea Russell at PSCI-CTO@pennstatehealth.psu.edu or 717-531-5471
All
18 year(s) or older
This study is NOT accepting healthy volunteers
NCT02927249
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Inclusion Criteria:
Histologic documentation of women or men with HER2 negative breast carcinoma and free of recurrence.
Prior adjuvant treatment with chemotherapy and/or endocrine therapy, as determined by the treating physician, is allowed.
Age > 18 and < 70 years of age.
ECOG performance status 0-2.
Patients with a prior history of gastric/duodenal ulcers documented on endoscopy can be enrolled as long as the ulcers did not cause bleeding requiring a blood transfusion/major intervention.
Exclusion Criteria:
No history of GI bleeding requiring a blood transfusion, endoscopic or operative intervention.
No history of any prior stroke (hemorrhagic or ischemic).
No concurrent anticoagulation with warfarin, heparin/heparin analogues, clopidogrel, direct thrombin inhibitors, or direct factor XA inhibitors.
No history of atrial fibrillation or myocardial infarction.
No history of grade 4 hypertension, defined as hypertension resulting in lifethreatening consequences
Cancer
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Hershey, PA

Using Exercise to Relieve Arthralgia (Joint Pain) and Improve AI Adherence in Older Survivors (REJOIN): A Pilot Study

Briefly, the purpose of this study is to use a self-management approach (combining education and exercise) to help older breast cancer survivors manage joint pain, a common side effect of aromatase inhibitors (AIs), a medication used to reduce hormones that might increase risk of recurrence and mortality following primary cancer treatment. We believe that reducing joint pain might help survivors take their medication longer and thus improve survival outcomes, compared to standard care.
Shirley Bluethmann at szb332@psu.edu
Female
18 year(s) or older
This study is NOT accepting healthy volunteers
NCT03955627
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Inclusion Criteria:
Age 65 and older
Female
Breast Cancer Survivor
Preparing to Start AI medication
ER+ diagnosis
Exclusion Criteria:
Already taking AI medication (greater than 2 weeks)
Gross Cognitive Impairment
Recent Joint Surgery
Cardiac event/Stroke within last 6 months
Not willing to come to HMC for Exercise Sessions
Cancer
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Hershey, PA

Phase II Study of Bendamustine and Rituximab plus Venetoclax in Untreated Mantle Cell Lymphoma over 60 Years of Age

This study is to see if venetoclax in combination with bendamustine and rituximab chemotherapy is effective in treating people who have mantle cell lymphoma and to examine the side effects, good and bad, associated with this combination .
CI-CTO Petrask at PSCI-CTO@pennstatehealth.psu.edu or 717-531-5471
All
18 year(s) or older
This study is NOT accepting healthy volunteers
NCT03834688
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Inclusion Criteria:
Must have histologically confirmed (biopsy-proven) diagnosis of mantle cell lymphoma (MCL)
Must have measurable or evaluable disease as defined as a lymph node measuring >1.5 cm in any dimension or splenomegaly with spleen >15 cm in craniocaudal dimension
ECOG performance status of 0-2
Adequate organ function as measured by the criteria
Total Bilirubin ≤ 1.5x upper limit of normal (ULN) or ≤ 3x ULN with documented Gilbert’s syndrome
Exclusion Criteria:
Should not have known evidence of central nervous system (CNS) lymphoma
Should not have prior chemotherapy, radiotherapy or immunotherapy for lymphoma
Must not have received a prior allogeneic stem cell transplant or solid organ transplant (except for cornea) for any indication
Must have no active, uncontrolled infections
Must not have active hepatitis B or be chronic carriers of hepatitis B.
Cancer
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Hershey, PA

Site for Phase III Study of Daratumumab/rHuPH20 (NSC-810307) + Lenalidomide or Lenalidomide as Post-Autologous Stem Cell Transplant Maintenance Therapy in Patients with Multiple Myeloma (MM) Using Minimal Residual Disease to Direct Therapy Duration (DRAMMATIC Study) (PSCI# 19-079) (S1803)

This study is being done to answer the following questions: 1. Will adding the drug daratumumab/rHuPH20 to the usual maintenance treatment with lenalidomide after stem cell transplant help multiple myeloma patients survive longer? 2. For patients who have no evidence of multiple myeloma in their bone marrow (patients who do not have “minimum residual disease” [MRD-negative]), should maintenance therapy be stopped after 2 years? We are doing this study because we want to find out if this approach is better or worse than the usual approach for your multiple myeloma. The usual approach is defined as care most people get for multiple myeloma.
Kathleen Rizzo at PSCI-CTO@pennstatehealth.psu.edu or 717-531-5471
All
18 year(s) or older
This study is NOT accepting healthy volunteers
NCT04071457
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Inclusion Criteria:
Patients must have had a confirmed diagnosis of symptomatic multiple myeloma (See Section 4.1) that required systemic induction therapy prior to autologous stem cell transplantation (ASCT).
Patients with disease measurable by serum light chain assay alone are eligible (defined as ≥ 100 mg/L on involved light chain).
Patients must be ≥ 18 and ≤ 75 years of age at time of registration to Step 1.
Patients must have history and physical exam within 28 days prior to registration.
Patients must have Zubrod Performance Status ≤ 2.
Exclusion Criteria:
Patients with smoldering myeloma are not eligible
Patients must not have any organ involvement by amyloidosis or evidence of amyloidosis related organ dysfunction.
Patients must not have progressive disease at any time prior to registration.
Patients must not be refractory or intolerant to either lenalidomide or daratumumab/rHuPH20.
Patients must not have moderate or severe persistent asthma within the past 2 years and must not have currently uncontrolled asthma of any classification.
Cancer
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Hershey, PA

A151216-Adjuvant Lung Cancer Enrichment Marker Identification and Sequencing Trial (Alchemist)

Purpose of study is to examine lung cancer patients' surgically removed tumors for certain genetic changes and to possibly refer these patients to a treatment study with drugs that may specifically these tumors.
Michelle Eschbach at meschbach@pennstatehealth.psu.edu or 610-378-2336
All
18 year(s) or older
This study is NOT accepting healthy volunteers
NCT02194738
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Inclusion Criteria:
Surgically resected non-small cell lung cancer
Pathologic stage IIIA, II (IIA or IIB) or large IB (defined as size ≥4 cm).
Tissue available for the required analyses
Exclusion Criteria:
No patients with recurrence of lung cancer after prior resection
No prior treatment with agents targeting EGFR mutation, ALK rearrangement, and PD1/PD-L1/CTLA-4.
Cancer
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Reading, PA

Site for A Randomized Phase II/III Trial of De-intensified Radiation Therapy for Patients with Early-Stage, P16-Positive, Non-Smoking Associated Oropharyngeal Cancer (NRG-HN005) (PSCI# 20-011)

The purpose of the first part of this study is to compare the usual treatment of a standard-dose radiation given over 6 weeks with cisplatin chemotherapy to a reduced-dose radiation given over either 6 weeks with cisplatin or 5 weeks with the immunotherapy drug, nivolumab. A lower dose of radiation as compared to the usual radiation treatment dose could be as effective in lengthening the time without your cancer getting worse. Nivolumab with reduced-dose radiation may or may not be as effective in lengthening the time without your cancer getting worse. This study will help the study doctors find out if this different approach is the same or worse than the usual approach.
Irina Geier at PSCI-CTO@pennstatehealth.psu.edu or 717-531-5471
All
18 year(s) or older
This study is NOT accepting healthy volunteers
NCT03952585
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Inclusion Criteria:
Pathologically proven diagnosis of squamous cell carcinoma of the oropharynx
Patients must have clinically or radiographically evident measurable disease at the primary site or at nodal stations
P16-positive based on local site immunohistochemical tissue staining
Zubrod Performance Status of 0-1 within 14 days prior to registration
Only English, Spanish, or French speaking patients are eligible to participate as these are the only languages for which the mandatory dysphagia-related patient reported instrument (MDADI) is available
Exclusion Criteria:
Clinical stages T0; T4; T1-2, N0; or any N2 (AJCC, 8th ed)
Recurrent disease
Definitive clinical or radiologic evidence of metastatic disease or adenopathy below the clavicles
Cancers considered to be from an oral cavity site or the nasopharynx, hypopharynx, or larynx, even if p16-positive, or histologies of adenosquamous, verrucous, or spindle cell carcinomas
Carcinoma of the neck of unknown primary site origin (T0 is ineligible, even if p16-positive)
Cancer
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Hershey, PA

The OVAL Study: A Randomized, Controlled, Double-Arm, Double-Blind, Multi-Center Study of Ofranergene Obadenovec (VB-111) Combined with Paclitaxel vs. Paclitaxel Combined with Placebo for the Treatment of Recurrent Platinum-Resistant Ovarian Cancer

To evaluate the efficacy of the combination of intravenous administration of VB-111 and paclitaxel compared to placebo and paclitaxel in patients with platinum resistant ovarian cancer as measured by Overall Survival (OS).
Lea Russell at lrussell@pennstatehealth.psu.edu
Female
18 year(s) or older
This study is NOT accepting healthy volunteers
NCT03398655
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Inclusion Criteria:
Histologically confirmed epithelial ovarian cancer and documented disease.
Patients must have platinum-resistant disease
Patients must have disease that is measurable according to RECIST 1.1 and require chemotherapy treatment.
Adequate hematological functions: ANC ≥ 1000/mm3 PLT ≥ 100,000/mm3 PT and PTT (seconds) < 1.2 X ULN. Patients who are anticoagulated do not need to meet criteria for PT and PTT.
Patients who are known to carry a BRCA mutation may be enrolled only after (following PARP inhibitor treatment failure, or being intolerant of, or ineligible for PARP inhibitor treatment).
Exclusion Criteria:
Non-epithelial tumors (Carcino-sarcomas are excluded)
Ovarian tumors with low malignant potential (i.e. borderline tumors) clear cell carcinomas, grade 1 serous tumors or mucinous tumors.
Patients who had evidence of disease progression during or up to 90 days from the last dose of the first line of platinum based therapy
Previous ovarian cancer treatment with >5 anticancer regimens.
Any prior radiotherapy to the pelvis or whole abdomen.
Cancer
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Hershey, PA

A Phase Ib/II Study of APG-115 in Combination with Pembrolizumab in Patients with Unresectable or Metastatic Melanomas or Advanced Solid Tumors

Part 1 (Phase Ib): To determine the safety and ability for subjects to tolerate APG-115 when combined with pembrolizumab, as well as the maximum tolerated dose in subjects with metastatic melanomas or solid tumors. Part 2 (Phase II): To determine the overall response rate of APG-115 when combined with pembrolizumab in the treatment of patients with unresectable or metastatic melanomas.
Irina Geier at igeier@pennstatehealth.psu.edu
All
18 year(s) or older
This study is NOT accepting healthy volunteers
NCT03611868
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Inclusion Criteria:
Male or non-pregnant, non-lactating female patients age ≥18 years on day of signing the informed consent
Histologically confirmed, unresectable or metastatic melanoma, and refractory or relapse after PD1 antibody treatment and ineligible for other standard of care therapy
ECOG Performance scale of 0-2
Life expectancy of equal to or greater than 3 months
Adequate bone marrow and organ functionAdequate
Exclusion Criteria:
Any prior systemic MDM2-p53 inhibitor treatment Received chemotherapy within 21 days (42 days for nitrosoureas or mitomycin C) prior to first dose.
Prior loco-regional treatment with intralesional therapy (e.g. talimogene laherparepvec) for unresectable or metastatic melanoma in the last 6 months prior to start of study treatment.
Received hormonal and biologic (<1 half-lives), small molecule targeted therapies or other anti-cancer therapy within 21 days prior to first dose Radiation or surgery within 14 days of study entry, thoracic radiation within 28 days prior to first dose.
Has known active central nervous (CNS) metastases and/or carcinomatous meningitis. Or has neurologic instability per clinical evaluation due to tumor involvement of the CNS.
Requirement for corticosteroid treatment, with the exception of megestrol, local use of steroid: i.e.: topical corticosteroids, inhaled corticosteroids for reactive airway disease, ophthalmic, intraarticular, and intranasal steroids.
Cancer
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Hershey, PA

A Phase 3, Randomized, Placebo-Controlled Clinical Study to Evaluate the Safety and Efficacy of Stereotactic Body Radiotherapy (SBRT) with or without Pembrolizumab (MK-3475) in Participants with Medically Inoperable Stages I or IIA Non Small Cell Lung Cancer (NSCLC)(KEYNOTE-867)(MK 3475-867)

This Phase 3 study is to compare the Event Free Survival (EFS) of using SBRT in combination with pembrolizumab and compared to SBRT in combination with placebo. To compare Overall Survival (OS) of using SBRT in combination pembrolizumab and compared to SBRT in combination with placebo.
Irina Geier at igeier@pennstatehealth.psu.edu or 717-531-8678
All
18 year(s) or older
This study is NOT accepting healthy volunteers
NCT03924869
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Inclusion Criteria:
Has an ECOG Performance Status of 0, 1, or 2.
Has previously untreated NSCLC diagnosed by histology or cytology and confirmed as Stage I or IIA NSCLC (AJCC 8th edition) by chest CT and PET scan.
Cannot undergo thoracic surgery due to existing medical illness(es)
A female is eligible to participate if she is not pregnant and not breastfeeding
Is male or female ≥18 years of age
Exclusion Criteria:
Has received prior therapy with an anti-PD-1, anti-PD-L1, or anti PD-L2 agent or with an agent directed to another stimulatory or co-inhibitory T-cell receptor
Has received prior radiotherapy to the thorax, including radiotherapy to the esophagus, mediastinum, or breast
Has received a live vaccine within 30 days prior to the first dose of study drug.
Has a diagnosis of immunodeficiency or is receiving chronic systemic steroid therapy
Has a known additional malignancy that is progressing or has required active treatment within the past 3 years
Cancer
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Hershey, PA

Site for MRI Brain Surveillance Alone Versus MRI Surveillance and Prophylactic Cranial Irradiation (PCI): A Randomized Phase III Trial in Small-Cell Lung Cancer (MAVERICK) (S1827) (PSCI# 20-086)

The purpose of this study is to compare the effects of using brain MRIs alone versus brain MRIs plus PCI on the lifespan of patients with small cell lung cancer. The use of brain MRIs alone could reduce side effects of receiving PCI. This study is hoping to show that monitoring with MRI scans alone (delaying radiation until the actual spread of the cancer) is at least as good as the combination of PCI with MRI scans. There will be about 668 people taking part in this study.
All
18 year(s) or older
This study is NOT accepting healthy volunteers
NCT04155034
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Inclusion Criteria:
Patient must have a histologically confirmed diagnosis of small-cell lung cancer (SCLC).
Patient must have an MRI of the brain performed within 28 days prior to registration.
Patient must have Zubrod Performance Status of 0-2
Patient must be ≥ 18 years of age.
All adverse events from prior treatment must have resolved to ≤ Grade 2 (CTCAE Version 5.0) prior to randomization.
Exclusion Criteria:
Patient must not have a contraindication to gadolinium contrast administration during MR imaging, such as allergy or insufficient renal function
Patient must not have other metastatic malignancies requiring current active treatment.
Patient must not have any severe active comorbidities
Patient must not have received prior radiotherapy to the brain or whole brain radiotherapy.
Patient must not have a contraindication to MR imaging, such as implanted metal devices or foreign bodies
Cancer
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Hershey, PA

Nurse AMIE for Echo Show: Randomized Control Trial

The Nurse AMIE platform has been modified to work as an Amazon Alexa Skill for use on the Echo Show device. We will recruit women receiving treatment for metastatic breast cancer and randomize them to receive standard treatment (control) or the Nurse AMIE for Echo Show program. Nurse AMIE is a supportive care program for women undergoing chemotherapy and helps them to manage their symptoms. We will test the feasibility of using the Nurse AMIE program as well as its effectiveness at managing symptoms.
Bethany Kanski at bkanski@phs.psu.edu
Female
18 year(s) or older
This study is NOT accepting healthy volunteers
NCT04673019
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Inclusion Criteria:
Female patient with metastatic breast cancer
At least 18 years of age
Personal in-home wi-fi access
Personal device capable of receiving telephone calls for weekly check-ins
Fluent in written and spoken English
Exclusion Criteria:
ECOG Performance Score of >2
Significant medical or psychiatric conditions (beyond breast cancer)
Receiving any behavioral intervention
Pregnant
Life expectancy of less than 6 months
Cancer
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Hershey, PA

Site for Phase II, Open-Label Safety and Efficacy Study of Telisotuzumab Vedotin (ABBV-399) in Subjects with Previously Treated c-Met+ Non-Small Cell Lung Cancer

This study is to determine the overall response rate (ORR) of telisotuzumab vedotin in subjects with c-Met+ non-small cell lung cancer.
Tricia Morrison at psci-cto@pennstatehealth.psu.edu or 717-531-5471
All
18 year(s) or older
This study is NOT accepting healthy volunteers
NCT03539536
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Inclusion Criteria:
Adult male or female, at least 18 years old
Subjects must have c-Met+ NSCLC as assessed by an AbbVie designated IHC laboratory or known documented MET gene amplification
Subjects have adequate bone marrow, renal, and hepatic function
Subjects are willing and able to comply with procedures required in this protocol
Subjects have an Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 or 1
Exclusion Criteria:
Subjects must not have a history of major immunologic reaction to any IgG containing agent
Subjects must not have psychiatric illness/social situation that would limit compliance with the study
Subjects must not have any medical condition which in the opinion of the Investigator or Therapeutic Area Medical Director (TA MD) places the subject at an unacceptably high risk for toxicities
Subjects must not have received any live vaccine within 30 days of the first dose of investigational product
Subjects must not have had major surgery within 21 days prior to the first dose of telisotuzumab vedotin
Cancer
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Hershey, PA

Site for A Randomized, Double-Blind, Phase III Trial of Paclitaxel/Trastuzumab/Pertuzumab with Atezolizumab or Placebo in First-Line HER2-Positive Metastatic Breast Cancer (NRG-BR004) (PSCI# 20-136).

The purpose of this study is to compare the usual treatment plus placebo to the usual treatment plus atezolizumab. The addition of atezolizumab to the usual treatment could stabilize your cancer. This study will help the study doctors find out if this different approach is better, the same, or worse than the usual approach. To decide if it is better, the study doctors will be looking to see if the atezolizumab lengthens the time during and after the treatment of your cancer that you live with your cancer and it is stable. Atezolizumab is already approved by the FDA for use in non-small cell lung cancer and urinary cancer. Its use in this study is considered experimental. There will be about 600 people taking part in this study.
All
18 year(s) or older
This study is NOT accepting healthy volunteers
NCT03199885
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Inclusion Criteria:
Patient must have an ECOG Performance Status of 0 or 1
Histologically confirmed adenocarcinoma of the breast with locally recurrent, unresectable disease, or metastatic disease
Adequate hematologic function within 14 days prior to randomization
Localized palliative radiation therapy is allowed for symptom management if completed 14 days or more prior to randomization
Adequate renal function determined within 14 days prior to randomization
Exclusion Criteria:
Patients with known primary central nervous system (CNS) malignancy or symptomatic CNS metastases are excluded
History of exposure to cumulative doses of doxorubicin greater than 360 mg per square meter of body surface area or its equivalent
Prior treatment with mTOR inhibitors or CDK 4/6 inhibitors in combination with endocrine therapy for treatment of metastatic disease
History of asymptomatic LVEF decline to < 40% during or after prior HER2-targeted therapy
Prior treatment with CD137 agonists or immune checkpoint-blockade therapies, including antiCD40, anti-CTLA-4, anti-PD-1, and anti-PD-L1 therapeutic antibodies
Cancer
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Hershey, PA

Site for NRG-LU002: MAINTENANCE SYSTEMIC THERAPY VERSUS LOCAL CONSOLIDATIVE THERAPY (LCT) PLUS MAINTENANCE SYSTEMIC THERAPY FOR LIMITED METASTATIC NON-SMALL CELL LUNG CANCER (NSCLC): A RANDOMIZED PHASE II/III TRIAL (PSCI# 21-028)

The purpose of this research study is to compare any good and bad effects of using the usual drug therapy plus radiation with or without surgery to treat the lung cancer and areas of metastasis (where the cancer has spread) compared with the usual drug therapy alone. Two types of radiation delivery will be used in this study. One type is called stereotactic body radiation therapy (SBRT) and will be used to treat areas of metastasis (parts of your body where the cancer has spread). SBRT uses special equipment to position a patient and precisely deliver radiation to tumors in the body. The total dose of radiation is divided into smaller doses given over several days. This type of radiation therapy helps spare normal tissue. The second type is standard radiation therapy and may be used to treat your primary lung tumor if SBRT cannot be used. Surgery also may be used to treat metastases or your primary lung tumor if you and your treating doctor decide this is a safe and better approach. Radiation, surgery, and usual drug therapy have already been tested for safety; however, using them in combination is not part of the usual approach. Adding radiation with or without surgery to the usual drug therapy could shrink or remove your tumor(s) or prevent the tumor(s) from returning but it could also cause side effects. This study will allow the researchers to know whether this different approach is better, the same, or worse than the usual therapy alone approach. Ultimately, to be better, the study treatment should increase life by six months or more compared to chemotherapy alone.
All
18 year(s) or older
This study is NOT accepting healthy volunteers
NCT03137771
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Inclusion Criteria:
Pathologically proven diagnosis of NSCLC, with metastases (stage IV disease) present prior to registration.
Age = 18;
Zubrod Performance Status 0, 1, or 2 within 30 days prior to registration;
Adequate organ and hematologic/bone marrow function within 14 days prior to registration
Negative serum pregnancy test within one week prior to registration for females of childbearing potential
Exclusion Criteria:
Prior bevacizumab therapy is excluded.
Clinical or radiologic evidence of new, untreated, and/or progressive brain metastases prior to registration after induction systemic therapy
Cutaneous metastasis of NSCLC;
Metastatic disease invading the esophagus, stomach, intestines, or mesenteric lymph nodes if not a candidate for surgery for these lesions;
Prior invasive malignancy (except non-melanomatous skin cancer, low or intermediate risk prostate cancer, or in situ carcinoma of breast, oral cavity, skin, or cervix) unless disease free for a minimum of one year
Cancer
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Hershey, PA

Site for Randomized Phase III Trial of MEDI4736 (durvalumab) as Concurrent and Consolidative Therapy or Consolidative Therapy Alone for Unresectable Stage 3 NSCLC (EA5181) (PSCI# 21-041).

The purpose of this study is to compare the usual approach of chemo/radiation followed by one year of MEDI4736 (durvalumab) to chemo/radiation with MEDI4736 (durvalumab) followed by one year of MEDI4736 (durvalumab). The addition of MEDI4736 (durvalumab) during chemo/radiation could prevent your cancer from returning and extend your life. But, it could also cause side effects. This study will help the study doctors find out if this different approach is better, the same, or worse than the usual approach. To decide if it is better, the study doctors will be looking to see if the study drug extends the life of patients and/or prevents the tumor from coming back as compared to the usual approach. This drug, MEDI4736 (durvalumab), is already approved by the FDA for use in other cancers, and for use in your type of cancer after the completion of chemotherapy and radiation. At this time MEDI4736 (durvalumab) is not yet approved (experimental) when given with chemotherapy and radiation. There will be about 660 people taking part in this study.
All
18 year(s) or older
This study is NOT accepting healthy volunteers
NCT04092283
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Inclusion Criteria:
Patient must be = 18 years old.
Patient must have an ECOG Performance Status of 0 or 1.
Body weight > 30 kg of patients.
Patient must not have unintentional weight loss > 10% within 30 days prior to registration.
Patient must have a baseline ECG obtained within 6 weeks of registration.
Exclusion Criteria:
Patient must not have any active, known or suspected autoimmune disease and neuromuscular paraneoplastic syndromes
Patient must not have a history of active hepatitis B (chronic or acute) or hepatitis C infection.
Patient must not have a known active tuberculosis infection.
Patient must not have any severe infections within 4 weeks prior to registration including, but not limited to, hospitalization for complications of infection, bacteremia, or severe pneumonia.
Patient must not have signs or symptoms of severe infection (sepsis) within 2 weeks prior registration.
Cancer
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Hershey, PA

DuRvalumab MEDI4730 with chEmotherapy as first line treAtment in advanced pleural Mesothelioma A phase 3 Randomised trial (DREAM3R) (PrE0506)(PSCI#20-123)

Participants may receive the medication Durvalumab in addition to standard of care medications or standard of care medications alone for treatment of Mesothelioma.
All
18 year(s) or older
This study is NOT accepting healthy volunteers
NCT04334759
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Inclusion Criteria:
unable to surgically remove pleural mesothelioma
post menopausal or negative pregnancy test
greater than 66 pounds in weight
life expectancy of at least 12 weeks
Exclusion Criteria:
prior chemotherapy
autoimmune disease
metastasized to the brain
Cancer
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Hershey, PA

Molecular-guided therapy for the treatment of patients with relapsed and refractory childhood cancers

Molecular-guided therapy for childhood cancer that has returned or is not responding to previous therapy.
Suzanne Treadway, MS, RN, CCRP at streadway@pennstatehealth.psu.edu or 771-531-3097
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All
This study is NOT accepting healthy volunteers
NCT02162732
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Inclusion Criteria:
A diagnosis of pediatric cancer of varying types for which there is no known cure or disease that is not responding to treatment.
Must be over one year of age at enrollment.
Must be less than or equal to 21 years at initial diagnosis.
Must have measurable disease by accepted standards.
Tumor must be accessible for biopsy.
Exclusion Criteria:
Has received chemotherapy within the last 7 days of biopsy.
Has received any radiotherapy to the primary sample site within the last 14 days.
Currently taking any other study drug.
Children's Health, Cancer
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Hershey, PA

A Phase II Trial of Nifurtimox for Refractory or Relapsed Neuroblastoma and Medulloblastoma

A study if the safety and effectiveness of nifurtimox in children with neuroblastoma or medulloblastoma, that has returned or is not responding to treatment.
Suzanne Treadway, MS, RN, CCRP at streadway@pennstatehealth.psu.edu or 717-531-3097
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All
This study is NOT accepting healthy volunteers
NCT00601003
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Inclusion Criteria:
Ages 0-21 years at the time of diagnosis.
Diagnosis of neuroblastoma or medulloblastoma.
Disease has not responded to previous treatment.
Disease is measurable bu accepted tests.
Exclusion Criteria:
Patients who weigh less than 3.5 kg (7.7 lbs).
Currently receiving another study drug.
Currently receiving other anticancer agents.
Children's Health, Cancer
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Hershey, PA

NMTT- Neuroblastoma Maintenance Therapy Trial Using Difluoromethylornithine (DFMO)

A study of DFMO for patients with neuroblastoma in remission.
Suzanne Treadway, MS, RN, CCRP at streadway@pennstatehealth.psu.edu or 717-531-3097
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All
This study is NOT accepting healthy volunteers
NCT02679144
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Inclusion Criteria:
A confirmed diagnosis of neuroblastoma.
Must be in complete remission (CR).
Tests and scans will be required to confirm remission.
Exclusion Criteria:
Patients below the defined minimum of height and weight.
Patients who are currently receiving another study drug may not participate.
Patients who are currently receiving other anticancer agents may not participate.
Children's Health, Cancer
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Hershey, PA

Phase I Study of Carfilzomib in combination with Cyclophosphamide and Etoposide for Children with Relapsed or Refractory Solid Tumors and Leukemias

A study of the safety of carfilzomib for children with solid tumors and leukemias that returned or did not respond to previous treatment.
Suzanne Treadway, MS, RN, CCRP at streadway@pennstatehealth.psu.edu or 717-531-3097
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All
This study is NOT accepting healthy volunteers
NCT02512926
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Inclusion Criteria:
Diagnosis of relapsed or refractory solid tumor.
Age 6 months to less than 30 years at enrollment.
Must be fully recovered from effects of previous treatment.
Life expectancy greater than or equal to 3 months.
Exclusion Criteria:
Prior treatment with carfilzomib.
Known allergy to Captisol®.
Down syndrome.
Children's Health, Cancer
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Hershey, PA

Nurse AMIE: A tablet based supportive care platform in Metastatic Breast Cancer (AMIE = Addressing Metastatic Individuals Everyday)

We propose to build and test a software program called Nurse AMIE (Addressing Metastatic Individuals Everyday) to be provided to Stage IV breast cancer patients on an electronic tablet. This program will be tested in 50 Stage IV breast cancer patients who live within the Penn State Cancer Institute’s 28 county catchment area. Goals of the Nurse AMIE are to regularly assess mental-health, physical health, and other symptom related needs among Stage IV breast cancer patients and to provide appropriate help via videos, weekly calls (face to face, tablet to tablet) with a patient guide at Penn State, and appropriate referrals to phone or in person visits (as needed). The proposed Nurse AMIE software program will allow for the plan of resources (videos, audio files, exercises) to help with many of the common symptoms and challenges experienced by the patients. This is an identified need on the part of both the patients and their medical care teams. Finally, it will also allow patient guides to check in with patients, review responses to surveys, decide whether new or different documents or videos are needed, and connecting the patient to palliative care and other services if additional care is found to be needed.
Female
18 year(s) or older
This study is NOT accepting healthy volunteers
N/A
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Inclusion Criteria:
metastatic breast cancer
ECOG<3
English speaking
sufficient vision/hearing or family support
Exclusion Criteria:
Medical or psychiatric conditions (beyond breast cancer, its treatment, and its symptoms) that would impair our ability to test study hypotheses (e. g. psychotic disorders, dementia, inability to give informed consent or follow the instruction).
Patients who are receiving any other behavioral intervention
Cancer
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Hershey, PA

A Phase III Randomized, Open Label, Multi-center Study of the Safety and Efficacy of Apixaban for Venous Thromboembolism Prevention versus No Systemic Anticoagulant Prophylaxis during Induction Chemotherapy in Children with Newly Diagnosed Acute Lymphoblastic Leukemia (ALL) or Lymphoblastic Lymphoma (T or B cell) Treated with Pegylated Asparaginase

A study to confirm and expand information on safety and effectiveness of apixaban to prevent blood clots as compared to no prevention treatment in children with newly diagnosed leukemia and lymphoma. This is a randomized study so patients will be selected by chance to be in either the group that receives apixaban or the group that does not receive apixaban.
Suzanne Treadway, MS, RN, CCRP at streadway@pennstatehealth.psu.edu or 717-531-3097
All
Younger than 18 years old
This study is NOT accepting healthy volunteers
NCT02369653
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Inclusion Criteria:
New diagnosis of leukemia (de novo ALL) or lymphoma (T or B cell).
An acceptable planned induction chemotherapy.
One year of age and older to less than 18 years of age.
Able to take oral medication or have it given through a tube.
Exclusion Criteria:
Had a blood clot in the past 3 months.
Known inherited bleeding disorder.
Children's Health, Cancer
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Hershey, PA