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Suggestions within category "Cancer"


62 Study Matches

A Phase I/II, Multicenter, Open-Label, Dose Escalation Study of the Safety and Pharmacokinetics of Cobimetinib in Pediatric And Young Adult Patients with Previously Treated Solid Tumors

A study of the safety and effectiveness of cobimetinib in patients with previously treated solid tumors.
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
NCT02639546
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Inclusion Criteria:
A solid tumor that has not responded to previous treatment.
Age must be 6 months or older to younger than 18 years of age.
Disease must be measurable by accepted tests.
Availability of tumor tissue at study enrollment is mandatory.
Exclusion Criteria:
Prior treatment with cobimetinib or other similar drug.
Treatment with high-dose chemotherapy and stem-cell rescue within 3 months prior to the study.
Children's Health, Cancer
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Hershey, PA

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
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 kar23@psu.edu
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.
Lea Russell at lmay1@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 mstojanovic1@pennstatehealth.psu.edu
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 lmay1@psu.edu
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

EXALT: EXercise Attenuates Liver Tumors Trial

Our goal is to better understand how exercise impacts patients with liver cancer in order to identify treatments that can improve outcomes and access to liver transplantation.
All
18 year(s) or older
This study is NOT accepting healthy volunteers
NCT03979547
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Inclusion Criteria:
Adults age >=18 or <70 years
Liver cancer diagnosis (HCC)
absence of all detectable cancer after your treatment
Exclusion Criteria:
active heart problems
BMI <18 or >45 kg/m2
Severe medical or mental illness
Cancer
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Hershey, PA

S1612-A Randomized Phase II/III Trial of “Novel Therapeutics” versus Azacitidine in Newly Diagnosed Patients with Acute Myeloid Leukemia (AML) or High-Risk Myelodysplastic Syndrome (MDS), Age 60 or Older

Purpose of this study is to compare any good and bad effects of using different new treatment options to one of the current standard treatment options given for patients with AML or MDS who cannot tolerate or do not want to get intensive chemotherapy.
Daniel Ward at dward1@pennstatehealth.psu.edu or 610-378-2336
All
18 year(s) or older
This study is NOT accepting healthy volunteers
NCT03092674
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Inclusion Criteria:
Untreated AML or MDS-EB-2
Patients must be ≥ 60 years of age
Patients must have disease present in the blood or bone marrow
Exclusion Criteria:
Patients with acute promyelocytic leukemia (APL), biphenotypic leukemia, blastic
Patients must not be known to have AML in the CNS.
Cancer
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Reading, 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 .
Jennifer Petrask at jpetrask@pennstatehealth.psu.edu or 717-531-8678
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

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
All
All
This study is NOT accepting healthy volunteers
N/A
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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

Feasibility and acceptability of mind-body strategies to increase physical activity and reduce health disparities in rural breast cancer survivors

The purpose of this study is to explore feasibility and acceptability of mind-body strategies to increase physical activity and reduce health disparities in rural cancer survivors and inform the cultural-adaptation of a physical activity intervention for rural breast cancer survivors.
Scherezade Mama at hdpar@psu.edu or 814-863-0132
All
18 year(s) or older
This study is NOT accepting healthy volunteers
N/A
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Inclusion Criteria:
At least 18 years of age
Received a cancer diagnosis previously
Lives in central Pennsylvania
Exclusion Criteria:
Below the age of 18
No history of cancer
Lives outside of the Penn State Cancer Institute's 28-county catchment area
Prevention, Mental & Behavioral Health, Cancer
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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
All
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
All
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
All
All
This study is NOT accepting healthy volunteers
NCT02512926
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Inclusion Criteria:
Diagnosis of relapsed or refractory leukemia or solid timor.
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 Thromboembolism Prevention versus No Systemic Anticoagulant Prophylaxis during Induction Chemotherapy in Children with Newly Diagnosed Acute Lymphoblastic Leukemia (ALL) or 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

A Phase 3, Randomized, Adaptive Study Comparing the Efficacy and Safety of Defibrotide vs Best Supportive Care in the Prevention of Hepatic Veno-Occlusive Disease in Adult and Pediatric Patients Undergoing Hematopoietic Stem Cell Transplant

A study to confirm and expand information on safety and effectiveness of defibrotide compared to best standard care to prevent veno-occlusive disease of the liver in adult and pediatric transplant patients. This is a randomized study so patients will be selected by chance to be in either the group that receives defibrotide or the group that does not receive defibrotide.
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
NCT02851407
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Inclusion Criteria:
Must be older than 1 month of age.
Scheduled for a stem cell transplant and be at high risk of veno-occlusive disease.
Be at high risk of veno-occlusive disease.
Exclusion Criteria:
Unstable blood pressure.
Episodes of bleeding.
Blood Disorders, Children's Health, Cancer
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Hershey, PA

A Phase 3 Multicenter Trial Evaluating the Efficacy and Safety of MitoGel™(UGN-101) on Ablation of Urothelial Carcinoma Lesions in the Upper Urinary Tract

This is a clinical trial, designed to determine safety &amp; effectiveness of and patient reaction to the use of MitoGel™ in the upper urinary system of patients with non-invasive low-grade (LG), urotheilal cancer (UTUC)
Kathleen Lehman at klehman3@pennstatehealth.psu.edu or 717-531-5930
All
18 year(s) or older
This study is NOT accepting healthy volunteers
NCT02793128
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Inclusion Criteria:
At least one (1) measurable and biopsy-confirmed papillary Low Grade tumor, evaluated visually, ≤ 15 mm.
ECOG (Eastern Cooperative Oncology Group) performance status <3 (with Karnofsky >40).
Life expectancy greater than 24 months.
Adequate organ and bone marrow function as determined by routine laboratory tests
New or recurrent patients with LG, non-invasive UTUC in the pyelocalyceal system.
Exclusion Criteria:
Patient received BCG treatment for UC during the 6 months prior to Visit 1.
The patient has untreated concurrent urothelial cancer in other locations other than the target area (unless treated during screening).
Carcinoma in situ (CIS) in the past in the urinary tract.
Patient has a history of invasive urothelial carcinoma in the urinary tract during the past 5 (Five) years.
Patient is actively being treated or intends to be treated with systemic chemotherapy during the duration of the trial.
Kidney & Urinary System, Cancer
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Hershey, PA

A Phase 2, Prospective, Randomized, Open-label Study on the Efficacy of Defibrotide Added to Standard of Care Immunoprophylaxis for the Prevention of Acute Graft-versus-Host-Disease in Adult and Pediatric Patients After Allogeneic Hematopoietic Stem Cell Transplant

A study of defibrotide to prevent acute GVHD. Subjects will be randomized to receive either defibrotide with routine prevention or to receive routine prevention alone.
Suzanne Treadway at streadway@pennstatehealth.psu.edu or 717-531-3097
All
All
This study is NOT accepting healthy volunteers
NCT03339297
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Inclusion Criteria:
Be ≥1 year and <75 years of age
A diagnosis of acute leukemia in remission
Exclusion Criteria:
Prior transplant
Acute bleeding
Cancer
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Hershey, PA

Effect of Group Led Creative Writing on Mood in Cancer Patients

The primary purpose of this study is to determine whether creative writing for cancer patients will have a positive impact on their mental health. Using a randomized controlled trial approach; we will be utilizing emotion thermometers to evaluate response on a number of domains such as anxiety, depression, despair and anger along with a series of survey questions to monitor changes in depressive and anxiety symptoms. Open-ended survey questions will be used to capture how this intervention impacts patient experience of their illness. Melissa Greene’s “Write from the Heart” program focuses more on creative writing rather than cancer focused topics. Patients in the intervention arm will have a minimum of four, 1.5 -hour group sessions with her over the span of two months. Patients in control arm will be provided a book (Writing Down Bones by Natalie Goldberg) about creative writing and will be asked to do activities for 1.5hrs every 2 weeks.
Darya Nesterova at dnesterova@pennstatehealth.psu.edu
All
18 year(s) or older
This study is NOT accepting healthy volunteers
N/A
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Inclusion Criteria:
Adult >20 years of age
Has cancer diagnosis
Ability to understand English language and ability to write without any functional difficulty
ECOG performance status 0-3
Exclusion Criteria:
Inability to give informed consent
Severe psychiatry illness (e.g., uncontrolled depression, schizophrenia or psychosis
Severe cognitive impairment
Pregnant females
Inability to write or understand English
Cancer
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Hershey, PA

GLNE 007 Evaluation of Stool Based Markers for the Early Detection of Colorectal Cancers and Adenomas

The purpose of this study is to see if stool, urine or blood can be used to determine whether or not a patient has any colon polyps or colon cancer. This study will compare these biological samples (blood, urine, stool) to any colonoscopy or surgery a patient has to see if the outcome could be predicted.
Amanda Taylor Gehman at ataylor6@pennstatehealth.psu.edu or 717-531-1283
All
18 year(s) or older
This study is also accepting healthy volunteers
N/A
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Inclusion Criteria:
Adult 18+
Subjects with Colon Cancer or Adenoma
OR subjects undergoing colonoscopy screening
Exclusion Criteria:
Inflammatory Bowel Disease
HIV/Hepatitis
Have had or are receiving chemotherapy or radiation
Have had surgery for your colon cancer
Cognitive Impairment
Prevention, Cancer
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Hershey, PA

Stakeholders' perspectives of collecting patient-level data on social determinants of health to identify patient needs and barriers to cancer care across the PSCI catchment area

This study will conduct one-on-one interviews with cancer patients, survivors, medical providers, and patient navigators to better understand individuals' experiences and opinions on the use of social information to improve cancer care. Social information includes one's current living situation, income, transportation needs, medical insurance coverage, social support system, and other related factors.
All
18 year(s) or older
This study is also accepting healthy volunteers
N/A
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Inclusion Criteria:
English or Spanish Speaking
Provides care for cancer patient(s)/survivor(s)
A cancer patient/survivor
Current role is a cancer patient care navigator
Exclusion Criteria:
Unable to speak English or Spanish
Under 18 years of age
Unwilling to be audio recorded
Cancer
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PhAse 1/2 StuDy of Modern ImmunotherApy in BCG-RelaPsing UroThelial Carcinoma of the BLADDER – (ADAPT-BLADDER) HCRN GU16-243 (PSCI 18-129)

This is a Phase II drug study which is designed to examine the effects of Durvalumab on individuals with bladder cancer that has not invaded muscle tissue. Study subjects will have already been treated with one or more surgical resections and Bacillus Calmette-Guerin or BCG, and the disease has now recurred.
Kathleen Rizzo at krizzo@pennstatehealth.psu.edu
All
18 year(s) or older
This study is NOT accepting healthy volunteers
NCT03317158
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Inclusion Criteria:
Histologically confirmed non-muscle invasive urothelial carcinoma of the bladder (Ta, T1, or Tis stage) on transurethral resection of bladder tumor (TURBT) obtained within 60 days of registration.
ECOG (WHO) performance status 0 or 1
Age ≥ 18 years old at time of consent
White blood cell count (WBC) > 3.0 K/mm3
Absolute neutrophil count (ANC) ≥ 1.5 K/mm3
Exclusion Criteria:
Subjects with muscle-invasive (i.e. T2, T3, T4), locally advanced unresectable, or metastatic urothelial carcinoma as assessed on baseline radiographic imaging obtained within 60 days prior to study registration.
Subjects with another active second malignancy other than non-melanoma skin cancers and biochemical relapsed prostate cancer.
Subjects that have completed all necessary therapy and are considered to be at less than 30% risk of relapse are not considered to have an active second malignancy and are eligible for enrollment.
Subjects who have received the last administration of an anti-cancer therapy including chemotherapy, immunotherapy, and monoclonal antibodies ≤ 4 weeks prior to starting study drug, or who have not recovered from the side effects of such therapy.
Subjects who have had any prior radiation to the prostate or pelvis.
Cancer
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Hershey, PA

GLNE 010: Validation and Comparison of Biomarkers for the Early Detection of Colorectal Adenocarcinoma

The purpose of this study is to see if stool, urine or blood can be used to find colon cancer as early or earlier than colonoscopy can. The researchers want to use these samples to learn about specific proteins or genes (also called biomarkers) that may indicate if someone has colon polyps (pre-cancer), colon cancer, or an increased risk for developing colon cancer. The researchers are part of a National Cancer Institute program called the Early Detection Research Network (EDRN). We have some biomarkers that are very promising, so we are testing them (“validating them”) in this study.
Amanda Taylor Gehman at ataylor6@pennstatehealth.psu.edu or 717-531-1283
All
18 year(s) or older
This study is also accepting healthy volunteers
NCT01511653
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Inclusion Criteria:
Scheduled for colonoscopy in the next 4 months
age 50 and older who are undergoing their first ever screening colonoscopy
adults age 70 and older with colonoscopy more than 9.5 years ago
willing to provide blood, urine and stool samples
able to tolerate removal of 5 tubes (3.5 tablespoons) of blood
Exclusion Criteria:
positive stool blood test (FIT/FOBT) in the past year
ever had colon or rectal cancer
history of inflammatory bowel disease
confirmed hereditary non-polyposis colorectal cancer, familial adenomatous polyposis, HIV or chronic viral hepatitis
cancer diagnosis or treatment in past year
Prevention, Digestive Systems & Liver Disease, Cancer
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Hershey, PA

Feasibility Study Phase C: Expansion in Multiple Institutions for Training in the Use of the LUM Imaging System for Intraoperative Detection of Residual Cancer in the Tumor Bed of Female Subjects with Breast Cancer

The main goal of standardizing the training for surgeons and clinical staff that will be participating in the anticipated pivotal study of the Lumicell Imaging System. Identify and address any site-specific or user-specific issues for using the LUM Imaging System in breast cancer patients and to collect safety and efficacy data.
Female
18 year(s) or older
This study is NOT accepting healthy volunteers
NCT02438358
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Inclusion Criteria:
Female, age of 18 years or older
Cytology confirmed primary invasive breast cancer, ductal carcinoma in situ or a combination of both
Scheduled for lumpectomy for a breast malignancy
No uncontrolled serious medical problems
Exclusion Criteria:
Subjects who are pregnant at the time of breast cancer diagnosis
Uncontrolled hypertension or other uncontrolled medical problems
Patient who is sexually active and not willing to use contraception-hormonal or barrier method, or abstinence for 60 days after injection
Individuals undergoing a second lumpectomy because of previous positive margins
Subjects who have taken an investigational drug in the 30 days prior to enrollement
Cancer, Women's Health
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Hershey, PA