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Suggestions within category "Cancer"


16 Study Matches

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

PSCI-17-085 Effect of Omega-3 Fatty Acid (EPA) and its Metabolites in Combination with Tyrosine Kinase Inhibitors (TKIs) in Chronic Myeloid Leukemia (CML) in Stable Chronic Phase

The purpose of this Phase I/II study is to evaluate the safety and efficacy of the combination of tyrosine kinase inhibitors (TKIs) and an omega-3 fatty acid (like fish oil) in patients with Chronic Myeloid Leukemia (CML).
Seema Naik at snaik@pennstatehealth.psu.edu
All
18 year(s) or older
This study is NOT accepting healthy volunteers
NCT04006847
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Inclusion Criteria:
Confirmed diagnosis of CML ≥ 18 months from diagnosis
Current concomitant treatment with TKI therapy (Imatinib, Dasatinib, Nilotinib or Bosutinib; excluding Ponatinib)
BCR-ABL PCR at stable molecular disease (e.g. MMR stable but not CMR) or b. Hematologic remission (HR) but no MMR
Stable molecular response defined as 2 sequential BCR-ABL levels done in the same lab with less than ½ log reduction of BCR-ABL (BA)
Eastern Cooperative Oncology Group (ECOG) Performance Status (PS) score more than or equal to 3
Exclusion Criteria:
Current malignancy requiring active treatment
Active infection requiring antibiotic treatment
Known HIV, Hepatitis B, or Hepatitis C infection
Known symptomatic congestive heart failure (CHF), unstable angina or cardiac arrhythmia
Current concomitant use of NSAIDs (including Aspirin) or COX-1; a washout period of 4 weeks prior to enrollment is permitted
Cancer
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Hershey, PA

A Phase II, Double-Blinded, Placebo-Controlled Randomized Trial of Salvage Radiotherapy With or Without Enhanced Anti-Androgen Therapy With Apalutamide in Recurrent Prostate Cancer

To determine whether, in men with post-prostatectomy PSA recurrences, salvage radiation (SRT) with enhanced anti-androgen therapy with apalutamide will improve biochemical progression-free survival (bPFS) compared to SRT alone.
Kathleen Rizzo at kar23@psu.edu
All
18 year(s) or older
This study is NOT accepting healthy volunteers
NCT03371719
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Inclusion Criteria:
Pathologically (histologically) proven diagnosis of prostate adenocarcinoma.
Post-prostatectomy patients with a detectable serum PSA (≥0.1, but ≤1.0 ng/mL) at study entry (within 90 days of Step 1 registration) a
pN0 or pNx
History/physical examination within 90 days prior to Step 1 registration
Karnofsky performance status of 70-100 within 90 days prior to Step 1 registration
Exclusion Criteria:
Definitive clinical, radiologic, or pathologic evidence of metastatic disease (M1) or lymph node involvement (N1)
Prior invasive malignancy (except non-melanomatous skin cancer, carcinoma in situ of the male breast, penis, oral cavity, or stage Ta of the bladder, or stage I completely resected melanoma) unless disease free for a minimum of 2 years
Prior systemic chemotherapy for the study cancer
Prior radiotherapy to the region of the study cancer that would result in overlap of radiation therapy fields;
Prior whole gland ablative therapy
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

NRG-GU002: Phase II-III Trial Of Adjuvant Radiotherapy and Androgen Deprivation Following Radical Prostatectomy With or without Adjuvant Docetaxel

Purpose of this study is to compare any good and bad effects of using docetaxel along with the radiation therapy and hormone suppression therapy versus using radiation and hormone suppression therapy alone in men with a high chance of prostate cancer recurrence after surgically removing the prostate.
Daniel Ward at dward1@pennstatehealth.psu.edu or 610-378-2336
Male
18 year(s) or older
This study is NOT accepting healthy volunteers
NCT03070886
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Inclusion Criteria:
post-prostatectomy with baseline Gleason ≥ 7
post prostatectomy PSA never undetectable
Any type of radical prostatectomy is permitted
Prior androgren deprivation therapy allowed
Exclusion Criteria:
Clinical or radiologic evidence of metastatic disease
Prior radiotherapy to the prostate
Prior chemotherapy for prostate cancer
Prostatectomy performed greater than 365 days prior to study entry
Cancer
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Reading, PA

Risk-based, response-adapted, Phase II open-label trial of nivolumab + brentuximab vedotin (N + Bv) for children, adolescents, and young adults with relapsed/refractory (R/R) CD30 + classic Hodgkin lymphoma (cHL) after failure of first-line therapy, followed by brentuximab + bendamustine (Bv + B) for participants with a suboptimal response. CheckMate 744: CHECKpoint pathway and nivolumab clinical Trial Evaluation

This is is a Phase 2, open-label study of nivolumab and brentuximab for children and young adults with relapsed/refractory classic Hodgkin lymphoma.
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
NCT02927769
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Inclusion Criteria:
Must be 5-30 Years of Age
A confirmed diagnosis of Classic Hodgkin Disease
Failed or did not respond to initial treatment
Exclusion Criteria:
A previous allogeneic stem cell transplant
Received certain antibody therapies in the past
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

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

PSCI-18-052 A Phase II Study to Evaluate the Response and Tolerability of Verzenio (Abemaciclib) in Patients with Advanced Biliary Tract Carcinoma who have Failed Prior Chemotherapy

The prognosis of patients with recurrent, late-stage inoperable, or progressed biliary tract carcinoma (BTC) is generally poor. The goal of this clinical study is to determine the effectiveness and safety of abemaciclib in patients with late-stage or progressed BTC that has failed one line of chemotherapy.
Irina Geier at igeier@pennstatehealth.psu.edu or 717-531-4300
All
18 year(s) or older
This study is NOT accepting healthy volunteers
NCT04003896
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Inclusion Criteria:
Histologic or cytologic evidence of advanced or metastatic biliary tract cancer including cholangiocarcinoma (intra-hepatic or extra-hepatic bile ducts), ampullary carcinoma, and gallbladder carcinoma.
Evidence of recurrent, locally advanced, or metastatic disease.
Progressed following or intolerant to one or more line of systemic therapy.
Presence of at least 1 lesion that is measurable or evaluable using Response Evaluation Criteria in Solid Tumors (RECIST) v1.1.
Adequate organ function, as evidenced by the laboratory parameters noted in Study Eligibility.
Exclusion Criteria:
Ongoing or active infection requiring systemic antibiotics.
History of previous venous thromboembolic events.
Uncontrolled hypertension despite adequate therapy (i.e., systolic blood pressure higher than 150 mm Hg or diastolic blood pressure higher than 90 mm Hg found on 2 separate occasions separated by 1 week).
Diabetes mellitus and occurrence of more than 2 episodes of ketoacidosis in the 12 months prior to the first dose of study drug.
Active second malignancy other than curatively resected basal cell carcinoma of the skin, squamous cell carcinoma of the skin, in situ carcinoma of the cervix, or other cancers with no known active disease in the 3 years prior to enrollment.
Cancer
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Hershey, PA

Phase II Trial of Palbociclib with Fulvestrant in Individuals with Hormone Receptor-Positive, HER2-Negative Metastatic Breast Cancer who have Progressed on Treatment with Palbociclib and an Aromatase Inhibitor

In this phase II trial, we will determine the progression-free survival (PFS) of the cyclin dependent kinase 4/6 inhibitor (CDK4/6i) palbociclib with fulvestrant in women and men with estrogen or progesterone receptor (ER/PR) positive, HER2-negative metastatic breast cancer (MBC) who progressed on treatment with palbociclib and an aromatase inhibitor (AI). We will also determine the prevalence rate of estrogen eceptor α (ESR1) and phosphatidylinositol-3-kinase (PI3K) mutations in the study population.
Lea May at lmay1@psu.edu
All
18 year(s) or older
This study is NOT accepting healthy volunteers
NCT02738866
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Inclusion Criteria:
Men and women, 18 years of age or older
Histologically or cytologically confirmed adenocarcinoma of the breast with evidence of metastatic disease (stage IV) or locally advanced disease,
ER-positive and/or PR-positive tumor (≥1% positive stained cells) • HER2-negative tumor
Progressed on and following at least 6 months of combined treatment with palbociclib and AI therapy for advanced/metastatic breast cancer, and be able and willing to receive additional palbociclib treatment
Eastern Cooperative Oncology Group (ECOG) performance status 0-2
Exclusion Criteria:
Women who are pregnant or breast-feeding
Concurrent use of any of the following medications during study participation: • Inhibitors or inducers of CYP3A4 that may affect serum concentrations of palbociclib
Major surgery, chemotherapy, radiotherapy, or other anti-cancer therapy within 2 weeks before registration.
Any other malignancy within 3 years prior to registration, except for adequately treated basal cell or squamous cell skin cancer, or carcinoma in situ of the cervix.
Prior hematopoietic stem cell or bone marrow transplantation.
Cancer
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Hershey, PA

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

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 Randomized Phase II/III Trial of Radiotherapy with Concurrent MEDI4736 (Durvalumab) vs. Radiotherapy with Concurrent Cetuximab in Patients with Locoregionally Advanced Head and Neck Cancer with a Contraindication to Cisplatin

The purpose of this study is to compare any good and bad effects of usual radiation plus the study treatment drug (durvalumab), to the usual therapy of radiation plus the drug (cetuximab) in patients with head and neck cancer who cannot take the drug cisplatin.
Irina Geier at iug29@psu.edu
All
18 year(s) or older
This study is NOT accepting healthy volunteers
NCT03258554
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Inclusion Criteria:
squamous cell carcinoma
18 or older
Adequate hematologic function
Adequate hepatic function
Adequate renal function
Exclusion Criteria:
invasive malignancy within the past 3 years
Prior radiotherapy
Prior immunotherapy
Major surgery within 28 days prior to Step 1 registration
Uncontrolled hypertension
Cancer
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Hershey, PA

A Single Arm Phase II Study of Palbociclib in Combination With Tamoxifen as First Line Therapy for Metastatic Hormone Receptor Positive Breast Cancer: Big Ten Cancer Research Consortium (BTCRC-BRE15-016) (16-053)

Primary Objective The primary objective of the Phase II study is to estimate the activity of the combination of palbociclib and tamoxifen in first line therapy for women with HR(+)/HER2(-) advanced breast cancer who have not received prior systemic anti-cancer therapies for their advanced/metastatic disease, assessed by response rates (complete or partial response) (RR) based on RECIST 1.1 or MDA criteria (for patients with bone only disease). Secondary Objectives - Characterize safety and tolerability of palbociclib and tamoxifen in first line therapy for women with HR(+)/HER2(-) advanced breast cancer who have not received prior systemic anti-cancer therapies for their advanced/metastatic disease. - Evaluate progression-free survival (PFS) per local assessment and RECIST 1.1 or MDA criteria in subjects with HR(+)/HER2(-) advanced breast cancer who have not received prior systemic anti-cancer therapies for their advanced/metastatic disease treated with palbociclib in combination with tamoxifen. - Evaluate clinical benefit rate RR (complete, partial response, or stable disease, lasting 24 weeks or longer) based on RECIST 1.1 or MDA criteria in subjects with HR(+)/HER2(-) advanced breast cancer who have not received prior systemic anti-cancer therapies for their advanced/metastatic disease treated with palbociclib in combination with tamoxifen. - Measure overall survival (OS) at 2 years in subjects with HR(+)/HER2(-) advanced breast cancer who have not received prior systemic anti-cancer therapies for their advanced/metastatic disease treated with palbociclib in combination with tamoxifen.
All
18 year(s) or older
This study is NOT accepting healthy volunteers
NCT02668666
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Inclusion Criteria:
Locally advanced, locoregionally recurrent, or metastatic disease, not amenable to curative therapy
Histologically and/or cytologically confirmed diagnosis of ER positive and/or PR positive (ER>1%, PR>1%), Her2 negative breast cancer
No prior systemic anti-cancer therapy for advanced HR+ positive disease
Metastatic disease evaluable on imaging studies.
Adequate blood, liver and kidney function
Exclusion Criteria:
Prior treatment with any CDK 4/6 inhibitor
Confirmed diagnosis of HER2 positive disease
Known uncontrolled or symptomatic CNS metastases.
Prior (neo)adjuvant treatment with tamoxifen within the 12 months before study entry.
Prior history of blood clots, pulmonary embolism or deep vein thrombosis.
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

A Phase I/II, Multicenter, Open Label, Multi Arm Study Evaluating The Safety, Tolerability, Pharmacokinetics, And Preliminary Activity Of Idasanutlin In Combination With Either Chemotherapy Or Venetoclax In The Treatment Of Pediatric And Young Adult Patients With Relapsed/Refractory Acute Leukemias Or Solid Tumors

A study of the safety of idasanutlin for children with solid tumors and leukemias that returned or did not respond to previous treatment.
Suzanne Treadway at streadway@pennstatehealth.psu.edu or 717-531-3097
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All
This study is NOT accepting healthy volunteers
NCT04029688
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Inclusion Criteria:
1-30 year of age
Have a solid tumors or leukemia that returned or did not respond to previous treatment
Exclusion Criteria:
Have a primary CNS tumor
Have uncontrolled infection
Cancer
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Hershey, PA