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Suggestions within category "Cancer"


15 Study Matches

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

Site for A Phase III Randomized Trial Comparing Adjuvant MK3475 (Pembrolizumab) to Standard of Care Observation in Completely Resected Merkel Cell Carcinoma

The purpose of this Phase III study is to compare Overall Survival (OS) and Recurrence Free Survival (RFS) across the two arms: MK3475 (Pembrolizumab) to Standard of Care Observation. Patients will undergo standard clinical procedures including physical, labs, vitals, ecg's, and imaging.
Irina Geier at iug29@psu.edu
All
18 year(s) or older
This study is NOT accepting healthy volunteers
NCT03712605
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Inclusion Criteria:
Patients must have an ECOG performance Status: 0, 1, or 2
Patient must have a histological confirmation of diagnosis of Merkel cell carcinoma (MCC), pathologic stages (AJCC version 8) I-IIIb.
completely resected by surgery within 8 weeks before enrollment.
All patients must have disease-free status documented by a complete physical examination and conventional imaging studies within 4 weeks prior to randomization.
Patients must not be on active immunosuppression, have a history of life threating virus, have had other cancer diagnoses in the last two years
Exclusion Criteria:
Women who are pregnant
present metastases
previous systemic therapy or radiation therapy for Merkel cell carcinoma.
inoperable disease who have received radiation are not eligible.
history of (non-infectious) pneumonitis that required steroids or has current pneumonitis.
Cancer
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Hershey, PA

A Phase Ib/11 Study of Propranolol with fixed-dose Pembrolizumab in Patients with Unresectable Stage III and Stage IV Melanoma

This research is being done to find out the safety of propranolol and, identify the maximum tolerated dose of propranolol that can be administered in combination with pembrolizumab in patients with unresectable stage III and stage IV melanoma. This study will evaluate this novel combination of pembrolizumab and propranolol to see what effect it may have on how your cancer responds to the treatment combination.
Irina Geier at igeier@pennstatehealth.psu.edu or 717-531-4300
All
18 year(s) or older
This study is NOT accepting healthy volunteers
NCT03384836
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Inclusion Criteria:
Age >=18 years.
Participants must be newly diagnosed, treatment-naive with histologically confirmed stage IIIC unresectable melanoma or stage IV melanoma.
Have measurable disease per RECIST v1.1
Have an ECOG performance status 0-1
Exclusion Criteria:
Participants who have received previous immunotherapy for any cancer (excluding melanoma) including PD-1/PD-L1 inhibitors but not interferons and CTLA-4 inhibitors.
Participants with chronic autoimmune diseases
Other invasive cancers diagnosed < 3 years back that required systemic treatment. If diagnosed with other invasive cancer ≥ 3 years, should have complete recovery from all systemic toxicity except neuropathy and alopecia
Cancer
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Hershey, PA

Site for Phase III IGRT and SBRT VS IGRT and Hypofractionated IMRT for Localized Intermediate Risk Prostate Cancer (NRG-GU005) (PSCI# 19-073)

The purpose of this study is to compare any good and bad effects of using stereotactic body radiation therapy (SBRT), a technique that gives treatment in a shorter amount of time compared to the usual radiation therapy. SBRT is experimental for treating this type of cancer. SBRT uses special equipment to position a participant and precisely deliver radiation to tumors in the body. Both the study and the usual radiation treatments use daily images to guide the radiation treatment to protect normal tissue. The study treatment, treatment over a shorter amount of time, may prevent the tumor from returning but it could also cause side effects. This study will allow the researchers to know whether this different approach using SBRT is better, the same, or worse than the usual approach. To be better, the study treatment should increase the time without the cancer coming back by six months or more compared to the usual approach, and show improvements in side effects to the bladder or rectum.
Male
18 year(s) or older
This study is NOT accepting healthy volunteers
NCT03367702
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Inclusion Criteria:
ECOG Performance Status 0-1 60 days prior to registration
Previously untreated localized adenocarcinoma of the prostate
Clinical stage by digital rectal exam of either T1c or T2a/b
The prostate volume must be < 60 cc as reported at time of biopsy or by separate measure with ultrasound or other imagining modalities including MRI or CT scan
Age is 18 years or older
Exclusion Criteria:
Definitive clinical or radiologic evidence of metastatic disease. No nodal involvement or evidence of metastatic disease allowed as defined by screening of the pelvis
Definitive T3 disease on MRI
Prior or current invasive malignancy with current evidence of active disease within the past 3 years
Prior systemic chemotherapy for the study cancer; note that prior chemotherapy for a different cancer is allowable; must be off treatment
Prior radiotherapy to the region of the study cancer that would result in overlap of radiation therapy fields
Cancer
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Hershey, PA

Site for Phase III Randomized Trial of Concurrent Chemoradiotherapy with or without Atezolizumab in Localized Muscle Invasive Bladder Cancer (Study SWOG/NRG 1806) (PSCI#19-044)

The purpose of this study is to compare the effects, good and/or bad, of chemotherapy and radiation therapy with or without the use of atezolizumab, which is used to treat bladder cancer. The combination of chemotherapy, radiation therapy and the immunotherapy atezolizumab is considered experimental. If you decide to take part in this study, you will receive combined chemotherapy and radiation therapy which is called “chemoradiotherapy” either with or without the study drug. The chemoradiotherapy you will receive is standard of care and what your doctor thinks is best. You will receive chemoradiotherapy for up to 7 weeks. If you are assigned to the group receiving study drug, you will take the drug for up to 6 months in addition the chemoradiotherapy. Your doctor will continue to follow your condition for up to 5 years after you register to the study, even though you have finished treatment in the first year. Your doctor will watch you for side effects and to see how your cancer affects you. You will have clinic visits at 3 months from the time you stop taking treatment for the first two years and then twice a year for the third year and once a year thereafter until 5 years after you register to the study.
All
18 year(s) or older
This study is NOT accepting healthy volunteers
NCT03775265
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Inclusion Criteria:
Patients must have histologically proven, T2-T4a N0M0 urothelial carcinoma of the bladder within 70 days prior to randomization.
Patients must undergo radiological staging within 70 days prior to randomization. Imaging of chest, abdomen, and pelvis must be performed using CT or MRI. Patients must not have evidence of T4bN1-3 disease.
Patients with hydronephrosis are eligible if they have unilateral hydronephrosis and kidney function meets criteria specified.
Female patients of childbearing potential must have a serum pregnancy test prior to randomization.
Patients must be ≥ 18 years of age.
Exclusion Criteria:
Patient must not have received any systemic chemotherapy for their bladder cancer.
Patients must not have received prior treatment for muscle invasive bladder cancer including neoadjuvant chemotherapy for the current tumor.
Patients must not have a major surgical procedure within 28 days prior to randomization.
Patients must not have undergone prior allogeneic bone marrow transplantation or prior solid organ transplantation.
Patients must have adequate bone marrow function as evidenced by all of the following: ANC ≥ 1,500/microliter (mcL); platelets ≥ 100,000/mcL; Hemoglobin ≥ 9 g/dL. These results must be obtained within 28 days prior to randomization.
Cancer
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Hershey, PA

E4512- A Phase III Double-Blind Trial for Surgically Resected Early Stage Non-Small Cell Lung Cancer: Crizotinib versus Placebo for Patients with Tumors Harboring the Anaplastic Lymphoma Kinase (ALK) Fusion Protein

Purpose of this study is to compare any good and bad effects of using the study drug, crizotinib after completeion of surgery and in some cases after chemotherapy and/or radiation therapy for ALK-positive non-small cell lung cancer.
Michelle Eschbach at meschbach@pennstatehealth.psu.edu or 610-378-2336
All
18 year(s) or older
This study is NOT accepting healthy volunteers
NCT02201992
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Inclusion Criteria:
Patients must have undergone complete surgical resection of their
Patients must be registered to the ALCHEMIST-SCREEN (ALLIANCE
ALK positive
Patients must have completed any prior adjuvant chemotherapy or
Exclusion Criteria:
No prior treatment with crizotinib or another ALK inhibitor.
Cancer
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Reading, PA

Site for PD-INHIBITOR (NIVOLUMAB) AND IPILIMUMAB FOLLOWED BY NIVOLUMAB VS. VEGF TKI CABOZANTINIB WITH NIVOLUMAB: A PHASE III TRIAL IN METASTATIC UNTREATED RENAL CELL CANCER [PDIGREE] (PSCI# 19-109) (A031704)

The purpose of this study is to compare the usual treatment of advanced kidney cancer (treatment with ipilimumab and nivolumab followed by nivolumab alone) to the usual treatment with ipilimumab and nivolumab, followed by nivolumab with cabozantinib. This study will help the study doctors find out if this different approach is better than the usual approach. To decide if it is better, the study doctors will be looking to see if adding cabozantinib to nivolumab can increase the percentage of patients alive at 3 years from 60% to 70%.
All
18 year(s) or older
This study is NOT accepting healthy volunteers
NCT03793166
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Inclusion Criteria:
Histologic documentation of renal cell carcinoma with clear cell component
Age ≥ 18 years
Karnofsky performance status greater than or equal to 70%
Hemoglobin ≥8 g/dL
Platelet Count ≥ 100,000/mm3
Exclusion Criteria:
No prior previous systemic therapy for renal cell carcinoma.
No cancer therapy less than 28 days prior to registration; this includes radiation therapy.
Not pregnant and not nursing, because this study involves an agent that has known genotoxic, mutagenic, and teratogenic effects.
No history of HIV or active hepatitis B/C, or tuberculosis
No uncontrolled hypertension (systolic BP >150mmHg or diastolic BP
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 Phase III Randomized Open Label Study to Compare NKTR-214 Combined with Nivolumab to the Investigator's Choice of Sunitinib or Cabozantinib in Patients with Previously Untreated Advanced Renal Cell Carcinoma (PSCI 18-122)

The purpose of the study is to compare how well the drug called NKTR-214 works when combined with the other drugs: nivolumab, sunitinib, and cabozantinib in patients with renal cell carcinoma.
Kathleen Rizzo at krizzo@pennstatehealth.psu.edu
All
18 year(s) or older
This study is NOT accepting healthy volunteers
NCT03729245
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Inclusion Criteria:
18 years or older
Karnofsky Performance Status of at least 70
advanced or metastatic renal carcinoma
No prior systemic therapy
No active brain metastases
Exclusion Criteria:
Use of an investigational agent or an investigational device within 28 days of randomization
autoimmune disease
History of organ or tissue transplant
Prior major surgery or radiotherapy within 14 days
Any tumor invading the major blood vessels
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

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 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

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

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.
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