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Suggestions within category "Cancer"


99 Study Matches

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 PSCI-CTO@pennstatehealth.psu.edu or 717-531-5471
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

Pivotal study of the LUM Imaging System for assisting intraoperative detection of residual cancer in the tumor bed of female subjects with breast cancer.

The objective of this prospective, multi-center, single-arm study is to demonstrate the safety and efficacy of the LUM Imaging System (LUM015 imaging agent in conjunction with the LUM Imaging Device and decision software), in identifying residual cancer in the lumpectomy bed of female breast cancer patients in order to assist surgeons in reducing the rates of positive margins.
Female
18 year(s) or older
This study is NOT accepting healthy volunteers
NCT03686215
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Inclusion Criteria:
Subjects must have histologically or cytologically confirmed primary invasive breast cancer, ductal carcinoma in situ (DCIS) or primary invasive breast cancer with a DCIS component.
Female, age of 18 years or older. Because no dosing or adverse event data are currently available on the use of LUM015 in subjects <18 years of age, children are excluded from this study.
Subjects must be scheduled for a lumpectomy for a breast malignancy.
Subjects must be able and willing to follow study procedures and instructions.
Subjects must have no uncontrolled serious medical problems except for the diagnosis of breast cancer, as per the exclusion criteria listed below.
Exclusion Criteria:
Subjects who are treated for bilateral breast cancer resection procedure.
Subjects who are pregnant at the time of diagnosis of their breast cancer.
Subjects who are sexually active and not willing/able to use 2 medically acceptable forms of contraception (hormonal, barrier method of birth control, abstinence) upon entering the study and for 60 days after injection of LUM015.
Subjects who have taken an investigational drug within 30 days of enrollment.
Subjects who will have administration of methylene blue or any dye for sentinel lymph node mapping on the day of the surgery prior to imaging the lumpectomy cavity with the LUM Imaging Device.
Cancer
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Hershey, PA

Site for LungMAP: A MASTER PROTOCOL TO EVALUATE BIOMARKER-DRIVEN THERAPIES AND IMMUNOTHERAPIES IN PREVIOUSLY-TREATED NON-SMALL CELL LUNG CANCER

This is a screening study and there is no treatment. The purpose of this study is to collect blood samples to determine if you are able to participate in other LUNGMAP studies.
Irina Geier at iug29@psu.edu
All
18 year(s) or older
This study is NOT accepting healthy volunteers
N/A
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Inclusion Criteria:
pathologically proven non-small cell lung cancer
at least one line of systemic therapy for any stage of disease
Patients with known EGFR sensitizing mutations, EGFR T790M mutation, ALK gene fusion, ROS 1 gene rearrangement, or BRAF V600E
Patients must have Zubrod performance status 0-1
Patients must be ≥ 18 years of age.
Exclusion Criteria:
Patients must be willing to provide prior smoking history as required on the LungMAP Onstudy Form.
Patients under age of 18
Criteria documentation within 28 days
n/a
n/a
Cancer
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Hershey, PA
Reading, PA

Site for Tomosynthesis Mammographic Imaging Screening Trial (TMIST)_EA1151_PSCI 19-080

This study is being done to answer the following question: Can tomosynthesis mammography, three-dimensional x-ray imaging of the breast, lower your chance of developing life-threatening breast cancer through routine screening compared with digital mammography, two-dimensional x-ray imaging of the breast? We are doing this study because we want to find out which of the two usual approaches to breast cancer screening are better in the early detection of life-threatening breast cancers.
Swati Shah at sshah@pennstatehealth.psu.edu
Female
18 year(s) or older
This study is also accepting healthy volunteers
NCT03233191
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Inclusion Criteria:
Women age 45 or older and under age 75 at the time of study entry
Patients must be scheduled for, or have intent to schedule, a screening mammogram.
Patients must be able to tolerate digital breast tomosynthesis and fullfield digital mammographic imaging required by protocol.
Patients must be willing and able to provide a written informed consent.
Exclusion Criteria:
Women of childbearing potential must not be known to be pregnant or lactating.
Patients must not have new symptoms or signs of benign or malignant breast disease
Patients must not have had a screening mammogram within the last 11 months prior to date of randomization.
Patients must not have previous personal history of breast cancer including ductal carcinoma in situ
Patients must not currently have breast enhancements (e.g., implants or injections).
Prevention, Cancer, Women's Health
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Hershey, PA

CCTG MA.39- A Randomized Trial of Regional Radiotherapy in Biomarker Low Risk Node Positive Breast Cancer

Purpose of this study is to compare any good and bad effects of not using regional radiotherapy to using radiotherapy. The study will help researcher learn if not giving regional radiotherapy is just as good as using regional therapy to treat node positive breast cancer in women.
Michelle Eschbach at meschbach@pennstatehealth.psu.edu or 610-378-2336
Female
18 year(s) or older
This study is NOT accepting healthy volunteers
NCT03488693
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Inclusion Criteria:
Estrogen Receptor Positive / Her2 Negative Breast Cancer
No evidence of metastasis
1
•3 positive lymph nodes
May have had breast conserving surgery or mastectomy
40 years of age or older
Exclusion Criteria:
Nodal disease limited to micromets or isolated cells
History of ipsilateral breast cancer or DCIS
Synchronous or contralateral breast cancer
pT3 or pT4 disease
Neoadjuvant Chemotherapy for breast cancer
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%.
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
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

Impact of Prehabilitation in Oncology Via Exercise- Bone Marrow Transplant

The purpose of this study is to assess feasibility, safety, and acceptability of a prehabilitation exercise program for hematopoietic stem cell transplant patients. The second purpose of this study is to assess changes in physical function, fatigue, pain, quality of life, and transplant-related symptoms and complications in hematopoietic stem cell transplant patients.
All
18 year(s) or older
This study is NOT accepting healthy volunteers
NCT03886909
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Inclusion Criteria:
Hematological cancer (e.g. Acute Myeloid Leukemia, Multiple Myeloma, Chronic Lymphocytic Leukemia, etc.)
Females and males, 18 years of age and older
Fluent in written and spoken English
Scheduled for an inpatient autologous or allogeneic stem cell transplant at Penn State Cancer Institute
At least 2 weeks until scheduled transplant
Exclusion Criteria:
Not fluent in written and spoken English
Severe cardiovascular issues
Uncontrolled hypertension
Transplant physician does NOT approve
Cancer
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Harrisburg, PA
Hershey, PA

Managed Access Program (MAP) to provide access to CTL019, for acute lymphoblastic leukemia (ALL) or large B-cell lymphoma patients with out of specification leukapheresis product and/or manufactured tisagenlecleucel out of specification for commercial release

This study is to provide access to CTL019 for ALL or large B-cell lymphoma patients who are either out of manufactured specifications or out of specification leukapheresis product who would otherwise not be able to be treated with CTL019 due to commercial restrictions. This means these manufactured cells are not able to be used commercially and insurance will not pay or contribute to paying for the product.
Jen Petrask at jpetrask@pennstatehealth.psu.edu or 717-531-8678
All
All
This study is NOT accepting healthy volunteers
NCT03601442
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Inclusion Criteria:
patient to be treated has a serious or life threatening disease or condition and no comparable alternative therapy is available
patient is not eligible or able to enroll in a clinical trial
potential benefit to justify potential risk of the treatment use
provision of the investigational product will not interfere with the initiation, conduct or completion of a Novartis clinical trial
access to provision of investigational product is allowed per local laws and regulations
Exclusion Criteria:
product can be commercially manufactured per the specifications
evidence of CD19 negative disease in patients with B-cell ALL
active Hepatitis B, active or latent Hepatitis C, or HIV positivity
uncontrolled active infection or inflammation
pregnant or nursing women
Cancer
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Hershey, PA

A Phase 1/2, Open-label, Safety, Tolerability, Pharmacokinetics, and Anti-Tumor Activity Study of Repotrectinib in Pediatric and Young Adult Subjects with Advanced or Metastatic Malignancies Harboring ALK, ROS1, or NTRK1-3 Alterations

Repotrectinib for cancer that has returned or is not responding to treatment
Suzanne Treadway at streadway@pennstatehelath.psu.edu or 717-531-3097
All
All
This study is NOT accepting healthy volunteers
NCT04094610
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Inclusion Criteria:
You have cancer that has returned or is not respondin g to treatment
You are positive for certain changes in your genes which we will test you for as needed
Exclusion Criteria:
1. You have gastrointestinal disease, such as Crohn’s disease,
Cancer
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Hershey, PA

3D-PREDICT REGISTRY: 3D Prediction of Patient-specific Response using Ex vivo Interrogation of Live Cells from Tumors

Patients are being asked to participate in this study because they may have one of the following: Brain Cancer (high-grade gliomas (HGG) that are limited to Glioblastoma Multiforme (GBM) or Anaplastic Astrocytoma (AA)). This study will collect data for a registry that records how a patient's cancer tissue responds to different types of approved chemotherapy drugs. The results of the responses will be shared with the patient's physician. The purpose of this study is to measure the accuracy of new investigational laboratory tests which could predict which chemotherapies are most active to each individual patient’s tumor. KIYATEC has validated a test, the Ex-Vivo 3-Dimensional Drug Response Assay (EV3D, the Assay) prior to use in this study. In this study, KIYATEC will establish the clinical correlation and utility of the Assay in various cancer subtypes.
All
18 year(s) or older
This study is NOT accepting healthy volunteers
NCT03561207
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Inclusion Criteria:
Age 18 years and older
Diagnosis of or suspected diagnosis of glioblastoma multiforme (GBM) or anaplastic astrocytoma (AA)
Patient must undergo elective surgery or biopsy to remove tumor tissue
Consideration as a candidate for systemic therapy with cytotoxic chemotherapy, targeted small molecule inhibitors or immunotherapy
Exclusion Criteria:
Age of <18 years
Do not have a diagnosis of or suspected diagnosis of glioblastoma multiforme (GBM) or anaplastic astrocytoma (AA)
Patient will not have surgery or a biopsy as part of routine clinical practice
Patient has known active cancer metastatic to the brain except for patients with brain metastases that have been treated and are considered stable
Patient refuses to have the assay performed on their tissue
Neurology, Cancer
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Hershey, PA

Site for A Randomized, Double blind, Placebo-controlled, Multi-center, Phase III Study of CD24Fc for Prevention of Acute Graft-versus-Host Disease Following Myeloablative Allogeneic Hematopoietic Stem Cell Transplantation

The primary objective of the study is to compare the rate of 180 days grade III-IV acute GVHD-free survival (aGFS) between the two GVHD prophylaxis regimens. An event for this time-to-event outcome is defined as grade III-IV aGVHD, or death by any cause.
Rachael Griffith at PSCI-CTO@pennstatehealth.psu.edu or 717-531-5471
All
18 year(s) or older
This study is NOT accepting healthy volunteers
NCT04095858
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Inclusion Criteria:
Acute Myeloid Leukemia (AML) or Acute Lymphoblastic Leukemia (ALL) in remission.
Males or non-pregnant, non-lactating females, ≥ 18 years of age.
Karnofsky Performance Status ≥70%.
Patients must have normal or near normal organ function as defined by their treating institutions BMT program clinical practice guidelines.
Ability to understand and the willingness to sign a written informed consent document.
Exclusion Criteria:
Subjects may not have presence of active CNS disease or extramedullary disease.
Prior cytotoxic chemotherapy within 21 days from the initiation of HCT conditioning (i.e. intensive induction / consolidation for AML).
Matched sibling donor, cord blood and haploidentical donors are not eligible.
Pregnant and nursing mothers are excluded from this study.
Uncontrolled infections.
Cancer
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Hershey, PA

A Randomized Phase II Trial of Adjuvant Pembrolizumab versus Observation Following Curative Resection for Stage I Non-small Cell Lung Cancer (NSCLC) with Primary Tumors Between 1-4 cm:Big Ten Cancer Research Consortium BTCRC-LUN18-153 (PSCI# 20-043)

This is a research study to find out if giving a drug called pembrolizumab after lung cancer surgery does a better job at keeping the cancer from coming back than surgery alone. The usual approach for patients who are not in a study is to be followed closely by their doctor to watch in case the cancer returns. Participants in this study will be assigned by chance (flip of a coin) to be watched closely by their doctor or to receive a drug called pembrolizumab. Pembrolizumab is given as an infusion in the clinic once every six weeks. . You will have tests, exams and procedures that are part of your regular care and for study purposes. You will have scans every 12 weeks to make sure the cancer hasn’t come back. If you are assigned to receive pembrolizumab, you can continue to receive it for up to 1 year.
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
NCT04317534
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Inclusion Criteria:
Males and females age ≥ 18 years.
Patients must have undergone complete surgical resection of their stage I non-small cell lung cancer between 4-12 weeks prior to registration.
Pathological tumor size must be 1.0 – 4.0 cm in size.
ECOG Performance Score 0-1
Baseline CT chest must be performed within 28 days of randomization
Exclusion Criteria:
Patients with tumors that are known to harbor actionable EGFR mutations are NOT eligible.
No prior PD-1 or PD-L1 inhibitors are permitted.
No prior neo-adjuvant or adjuvant chemotherapy is permitted for this lung cancer.
Patients with a history of (non-infectious) pneumonitis that required steroids
Has active autoimmune disease that has required systemic treatment in the past 2 years.
Cancer
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Hershey, PA

Site for NRG-GU008, Randomized Phase III Trial Incorporating Abiraterone Acetate with Prednisone and Apalutamide and Advanced Imaging into Salvage Treatment for Patients with Node-Positive Prostate Cancer after Radical Prostatectomy (NCT #04134260)

The purpose of this study is to compare the use of hormone therapy and radiation therapy (usual treatment) to the use of apalutamide and abiraterone acetate with prednisone plus the usual treatment. The addition of apalutamide and abiraterone acetate with prednisone to the usual treatment could stabilize your cancer and prevent it from spreading. But it could also cause side effects, which are described in the risks section below. 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 approach increases the time without prostate cancer spreading compared to the usual approach. The study drugs, apalutamide and abiraterone acetate with prednisone, are already approved by the FDA for use in prostate cancer. But, most of the time abiraterone acetate with prednisone is not used until hormone drugs stop working and apalutamide is not used until hormone drugs stop working and after prostate cancer has spread. There will be about 586 people taking part in this study.
Kathleen Rizzo at PSCI-CTO@pennstatehealth.psu.edu or 717-531-5471
Male
18 year(s) or older
This study is NOT accepting healthy volunteers
NCT04134260
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Inclusion Criteria:
Pathologically (histologically) proven diagnosis of prostate adenocarcinoma
History/physical examination within 90 days prior to registration
ECOG Performance Status of 0-1 within 90 days prior to registration
Any T-stage is eligible (AJCC 8th ed)
Adequate hepatic function within 90 days prior to registration
Exclusion Criteria:
Didanosine (DDI) antiretroviral therapy is not permitted
Seizure or known condition that may pre-dispose to seizure
Severe or unstable angina, myocardial infarction, arterial or venous thromboembolic events within 6 months prior to registration
Any chronic medical condition requiring a higher dose of corticosteroid than 10 mg prednisone/prednisolone once daily
Patients with inflammatory bowel disease.
Cancer
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Hershey, PA

Phase 1 Study To Evaluate the Safety and Pharmacokinetics of Palbociclib (Ibrance®) in Combination with Irinotecan and Temozolomide and in Combination with Topotecan and Cyclophosphamide in Pediatric Patients with Recurrent or Refractory Solid Tumors

A study of the safety of palbociclib with irinotecan and temozolomide and palbociclib with topotecan and cyclophosphamide for children with solid tumors that returned or did not respond to previous treatment.
Suzanne Treadway at streadway@pennstatehealth.psu.edu or 717-531-3097
All
All
This study is NOT accepting healthy volunteers
NCT03709680
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Inclusion Criteria:
Have a solid tumor that has returned or did not respond to previous treatment
Ages ≥2 and <21
Exclusion Criteria:
Prior intolerability to the chemo drugs used in this study
Cancer
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Hershey, PA

Site for A Phase III, Randomized, Open-label Study of Adjuvant Immunotherapy with Bempegaldesleukin Combined with Nivolumab Versus Nivolumab After Complete Resection of Melanoma in Participants at High Risk for Recurrence (PIVOT-12)

This study is to compare the efficacy, as measured by recurrence-free survival (RFS) by a blinded independent central review (BICR) of bempegaldesleukin plus nivolumab versus nivolumab in patients with completely resected Stage IIIa, Stage IIIb/c/d, or Stage IV no evidence of disease (NED) cutaneous melanoma who are at high risk for recurrence.
Irina Geier at igeier@pennstatehealth.psu.edu or 717-531-4300
All
18 year(s) or older
This study is NOT accepting healthy volunteers
NCT04410445
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Inclusion Criteria:
Prior treated central nervous system (CNS) metastases must have magnetic resonance imaging (MRI) evidence of no recurrence for at least 4 weeks after treatment
Male or female patients age 12 years or older at the time of signing the informed consent form (ICF) (age 18 years or older where local regulations or institutional policies do not allow for patients < 18 years of age to participate).
Patients must have an Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1
Histologically confirmed Stage IIIA (LN metastasis > 1 mm [i.e., at least one LN metastasis measuring > 1 mm at greatest diameter]), IIIB/C/D, or IV (M1a/b/c/d) cutaneous melanoma by AJCC
Tumor tissue from biopsy or resected disease must be provided to central laboratory for PD-L1 status analysis
Exclusion Criteria:
Use of an investigational agent or an investigational device within 28 days before randomization
History of ocular/uveal melanoma or mucosal melanoma
Conditions requiring systemic treatment with either corticosteroids (> 10 mg daily prednisone equivalent) or other immunosuppressive medications within 14 days of randomization
Prior therapy for melanoma
History of leptomeningeal disease
Cancer
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Hershey, PA

Site for Randomized Phase II/III Trial of Adjuvant Radiation Therapy with Cisplatin, Docetaxel-Cetuximab, or Cisplatin-Atezolizumab in Pathologic High-Risk Squamous Cell Cancer of the Head and Neck (PSCI# 20-106) (RTOG-1216)

To determine if the combination of atezolizumab, cisplatin, and IMRT is superior to standard cisplatin and IMRT in the HNSCC.
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
NCT01810913
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Inclusion Criteria:
Pathologically (histologically or cytologically) proven diagnosis of head and neck squamous cell carcinoma
Patients must have undergone gross total surgical resection of high-risk oral cavity, oropharynx (p16 Negative), larynx, or hypopharynx within 63 days prior to registration
Pathologic stage III or IV HNSCC, including no distant metastases
Zubrod Performance Status of 0-1 within 14 days prior to registration
Adequate hepatic function
Exclusion Criteria:
Prior systemic chemotherapy or anti-EGF therapy for the study cancer; note that prior chemo for a different cancer is allowable
Severe, active co-morbidity
Grade 3-4 electrolyte abnormalities
Prior allergic reaction to cetuximab
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 NRG-GU007, Randomized Phase II Trial of Niraparib with Standard Combination Radiotherapy and Androgen Deprivation Therapy (ADT) in High Risk Prostate Cancer (With Initial Phase I) (NADIR*) (NCT 04037254) (PSCI# 20-104)

The purpose of this study is to compare the usual treatment alone to using the study drug niraparib plus the usual treatment. The addition of niraparib to the usual treatment could prevent your cancer from growing or returning. But, it could also cause side effects, which are described in the risks section below. This study will help the study doctors find out if this different approach is better, the same, or worse than the usual approach. To be better, the study approach should increase the chance of remaining cancer free to 50 out of 100 participants after 2 years, or a 20% improvement compared to the usual approach.
All
18 year(s) or older
This study is NOT accepting healthy volunteers
NCT04037254
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Inclusion Criteria:
ECOG performance status of 0 or 1 within 180 days prior to registration
Age is greater than or equal to 18 years old
Pretreatment serum PSA, obtained prior to any androgen suppression therapy and within 180 days of registration
Adequate hematologic, renal, and hepatic function within 90 days prior to registration
Men of child-producing potential must be willing to consent to use effective contraception while on treatment and for at least 3 months afterwards
Exclusion Criteria:
PSA > 150 ng/mL
Definitive clinical or radiologic evidence of metastatic disease
Pathologically positive lymph nodes or nodes > 1.5 cm short axis on CT or MR imaging
Prior radical prostatectomy, cryosurgery for prostate cancer, or bilateral orchiectomy for any reason
Prior systemic therapy for prostate cancer; note that prior therapy for a different cancer is allowable
Cancer
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Hershey, PA

STEEL: A Randomized Phase II Trial of Salvage Radiotherapy with Standard vs Enhanced Androgen Deprivation Therapy (with Enzalutamide) in Patients with Post-Prostatectomy PSA Recurrences with Aggressive Disease Features

Radiation treatment and hormonal therapy vs. Radiation treatment, hormonal therapy plus Enzalutamide in post-prostatectomy cancer recurrences.
Male
18 year(s) or older
This study is NOT accepting healthy volunteers
NCT03809000
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Inclusion Criteria:
Prostatectomy performed within 10 years prior to registration and any type of radical prostatectomy is permitted, including retropubic, perineal, laparoscopic or robotically assisted.
PSA level (≥0.2 ng/mL) within 90 days prior to registration.
Hemoglobin ≥9.0 g/dL, independent of transfusion and/or growth factors within 90 days prior to registration.
At least 1 of the following features: • Gleason score of 8-10 • Seminal vesicle invasion • Locoregional node involvement at radical prostatectomy • Persistently elevated PSA post-RP nadir
Exclusion Criteria:
Definitive clinical or radiologic evidence of metastatic disease with the exception of locoregional lymph nodes
Prior systemic chemotherapy for the study cancer; note that prior chemotherapy for a different cancer is allowable
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 Protocol NRG-LU007: RAndomized Phase II/III Trial Of Consolidation Radiation + Immuno-therapy for ES-SCLC: RAPTOR trial (NCT # NCT04402788) (PSCI# 20-118)

The purpose of this study is to compare the usual treatment of the immune therapy drug atezolizumab alone, to using radiation therapy plus the usual treatment. The addition of radiation to the usual treatment could shrink your cancer or prevent it from returning. 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 approach increases the life of patients or extends your time without disease compared to the usual approach.
All
18 year(s) or older
This study is NOT accepting healthy volunteers
NCT04402788
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Inclusion Criteria:
Pathologically proven diagnosis of extensive stage small cell lung cancer
measurable disease (per RECIST) and 3 or fewer observable liver metastases and no evidence of progressive disease at enrollment
Patients presenting with a pleural effusion will be eligible if thoracentesis is cytologically negative and non-bloody
ECOG Performance Status of 0-2 at the time of registration
Age ≥ 18
Exclusion Criteria:
Metastatic disease invading the liver (>3 metastases), heart or >10 metastatic sites
Prior invasive malignancy (except non-melanomatous skin cancer) unless disease free for 5 years prior to randomization
Chronic obstructive pulmonary disease (COPD) requiring chronic oral steroid therapy of > 10 mg prednisone daily or equivalent at the time of registration
Patients who have had immunotherapy-induced pneumonitis
History of recent myocardial infarction within 6 months prior to registration
Cancer
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Location
Hershey, PA

AYA-UNITE (Utilizing Novel Information Technology to Promote Exercise and Well-Being) in Adolescents and Young Adults with Cancer

Adolescents and young adults (AYAs) with cancer have many needs for supportive care that differ from younger and older patients. This includes age-appropriate psychological support for management of distress, as well as supports for the social isolation many AYAs experience. One exciting intervention that may provide AYAs with cancer improved psychosocial support, as well as increased physical strength, is physical activity. This feasibility project aims to evaluate the safety, feasibility and acceptability of a physical activity training in AYAs with cancer delivered via a socially interactive videoconferencing platform.
Pooja Rao at prao2@pennstatehealth.psu.edu or 717-531-6012
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All
This study is NOT accepting healthy volunteers
NCT03778658
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Inclusion Criteria:
Participant age 15-29 years old at time of cancer diagnosis

Participant diagnosis of cancer who is currently undergoing active treatment for cancer, or who is within 3 years of end of cancer treatment at the time of enrollment
Participant must have access to a computer or smartphone
Exclusion Criteria:
Cardiovascular or respiratory disease

Absolute contraindication to exercise
Pregnant women
Patients with relapsed cancer
atients who have undergone allogeneic stem cell transplant
Sports Medicine, Mental & Behavioral Health, Cancer
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Site for A Phase III Study of Pembrolizumab (MK-3475) in Combination with Concurrent Chemoradiation Therapy Followed by Pembrolizumab with or without Olaparib, Compared to Concurrent Chemoradiation Therapy Followed by Placebo in Participants with Newly Diagnosed Treatment-Naïve Limited-Stage Small Cell Lung Cancer (LS-SCLC) (MK7339-013)

This is a Phase 3 Study of the study drug Pembro in combination with chemoradiation followed by Pembro alone or with a combination of Pembro/Olaparib in subjects without prior treatment of Limited Stage Small Cell Lung Cancer.
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
NCT04380636
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Inclusion Criteria:
Has pathologically (histologically or cytologically) confirmed SCLC.
Has LS-SCLC (Stage I-III, by AJCC 8th Edition Cancer Staging), and can be safely treated with definitive radiation doses.
Has no evidence of metastatic disease by whole body PET/CT scan, CT or MRI scans of diagnostic quality of chest, abdomen, pelvis and brain.
Has not received prior treatment (chemotherapy or radiotherapy or surgery resection) of LS-SCLC.
Has ECOG Performance score 0 or 1 assessed within 7 days prior to the first administration of study intervention.
Exclusion Criteria:
Has history, current diagnosis, or features suggestive of MDS/AML.
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 therapy with olaparib or with any other PARP inhibitor.
Had major surgery <4 weeks prior to the first dose of study intervention
Has received colony-stimulating factors 28 days prior to the first dose of study intervention.
Cancer
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Hershey, PA

Site for EA6192: A Phase II Study of Biomarker Driven Early Discontinuation of anti-PD-1 Therapy in Patients with Advanced Melanoma (PET-Stop) (PSCI# 20-097)

The purpose of this study is to compare the safety and effects of stopping the standard treatment with nivolumab or pembrolizumab early with the safety and effects of not stopping the standard treatment early on people’s risk of having advanced melanoma cancer spread more. In this study, you will continue on your standard of care treatment for one more year or you will discontinue your standard of care treatment. Whether you continue or stop treatment is dependent on the results of a PET/CT scan and, if needed, a biopsy. PET/CT scan can be useful for monitoring your type of cancer. There will be about 150 people taking part in this study.
All
18 year(s) or older
This study is NOT accepting healthy volunteers
NCT04462406
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Inclusion Criteria:
Patient must be ≥ 18 years of age.
Patient must have active advanced melanoma, defined as unresectable stage IIIB-IV by AJCC 8th edition
Patient must have an ECOG performance status of 0-2
Patient must have completed an FDG-PET/CT scan at week 52 (+/- 2 weeks) from start of initial anti-PD-1 therapy
For patients with HCV infection who are currently on treatment, they are eligible if they have an undetectable
Exclusion Criteria:
Patient must not have brain metastases
Women must not be pregnant or breast-feeding
Patient must not be receiving concurrent anti-tumor therapies in addition to the standard of care anti-PD-1 regimens
Cancer
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Hershey, PA

IMpact of PRehabilitation in Oncology Via Exercise – Breast cancer

It is well known that breast cancer patients suffer from many cancer- and treatment-related side effects that all worsen overall quality of life. Besides dealing with existing treatment-related side-effects, there is the idea of prehabilitation a process on the cancer continuum of care that occurs between the time of cancer diagnosis and the beginning of acute treatment. IMPROVE-B will evaluate an exercise prehabilitation approach with regard to safety, feasibility, acceptability and effectivity in breast cancer patients (n=30) prior surgery.
Joachim Wiskemann at jwiskema@phs.psu.edu or 717-531-0003, ext=289736
All
18 year(s) or older
This study is NOT accepting healthy volunteers
N/A
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Inclusion Criteria:
Scheduled for breast cancer surgery
Not metastatic (stage <4)
more than 2 weeks till surgery
Exclusion Criteria:
Receiving neoadjuvant chemotherapy or radiotherapy
Pregnant
• Engaging in systematic intense exercise training (at least 1h twice per week)
Cancer
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Hershey, 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

CUFF Study: Characterization of Upper Limb Function following Mastectomy and Reconstruction for Breast Cancer

This is an observational study that will provide information describing the relationships between type of breast reconstruction and shoulder/upper extremity function and perceived health-related quality of life (HRQOL) for breast cancer survivors. This study will obtain measurements of arm strength and mobility and use self-report questionnaires to evaluate patient quality of life and satisfaction with treatment. Outcomes across three patient groups will be compared, including patients who undergo mastectomy with: 1) no reconstruction; 2) reconstruction with implants; and 3) reconstruction with autologous flaps.
Meghan Vidt at mzv130@psu.edu or 814-865-6885
Female
18 year(s) or older
This study is NOT accepting healthy volunteers
N/A
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Inclusion Criteria:
Women aged 18-79 years old
Plan to undergo mastectomy as a part of breast cancer treatment
Mastectomy with or without secondary reconstruction
Exclusion Criteria:
Men
Women who do not plan to have mastectomy as a part of their breast cancer treatment
History of a stroke or neuromuscular disorder (e.g. Parkinson's disease, tremor)
Severe arthritis that affects how you move
Any condition that affects memory (e.g. Alzheimer's disease, dementia)
Cancer
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Hershey, PA

A Phase 1b-2 Study to Evaluate Safety, Efficacy, Pharmacokinetics, and Pharmacodynamics of Various Regimens of Erdafitinib in Subjects with Metastatic or Locally Advanced Urothelial Cancer

The purpose of this study is to see whether taking the drug Erdafitinib and the drug JNJ-63723283 is safe and effective in treating patients with advanced bladder cancer.
Kathleen Rizzo at kar23@psu.edu or 717-531-0003, ext=289630
All
18 year(s) or older
This study is NOT accepting healthy volunteers
NCT03473743
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Inclusion Criteria:
≥18 years of age.
Histologic demonstration of transitional cell carcinoma of the urothelium.
Stage IV disease (metastatic or Locally Advanced cT4b, N+, or M+ cancer).
Meet appropriate molecular eligibility criteria
Documented progression of disease per RECIST 1.1, defined as any progression that requires a change in treatment, prior to randomization.
Exclusion Criteria:
Treatment with any other investigational agent or participation in another clinical study with therapeutic intent within 30 days prior to Cycle 1 Day 1. For Phase 1b, subjects who have received the following prior antitumor therapy
Chemotherapy within 3 weeks of Cycle 1 Day 1
Prior anti-PD-1, anti-PD-L1, or anti-PD-L2 therapy
Active malignancies (ie, requiring treatment change in the last 24 months) other than urothelial cancer (except skin cancers within the last 24 months that are considered completely cured).
Symptomatic central nervous system metastases.
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 PSCI-CTO@pennstatehealth.psu.edu or 717-531-5471
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

Effect of oral black raspberry administration on oral cell DNA adducts in smokers

This is an intervention study that will examine the effect of black raspberry lozenges on mouth cell DNA damage in smokers.
Nicolle Krebs at nkrebs@pennstatehealth.psu.edu or 717-531-5673
All
18 year(s) or older
This study is also accepting healthy volunteers
N/A
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Inclusion Criteria:
Smokers (15 cigarettes per day or more)
21-65 years of age
No quit attempt in the prior 30 days
No plans to quit smoking in next 4 months
Willingness and ability to attend 8 visits over 13 weeks
Exclusion Criteria:
Current unstable or significant medical condition
Women who are pregnant or nursing
Use of marijuana or other illegal drugs
Any known allergy to raspberries
Heavy drinking (>4 drinks/day, 5 days/wk)
Smoking, Vaping, Nicotine and Tobacco, Prevention, 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

A Randomized, Placebo-Controlled, Double-Blind Study of Adjuvant Cemiplimab versus Placebo after Surgery and Radiation Therapy in Patients with High Risk Cutaneous Squamous Cell Carcinoma (CSCC) (PSCI 18-112)

This study is a comparison of disease-free survival of patients with high-risk cutaneous squamous cell carcinoma (CSCC) when treated with a medication (cemiplimab) versus those treated with placebo after already having surgery and radiation therapy.
Irina Geier at igeier@pennstatehealth.psu.edu
All
18 year(s) or older
This study is NOT accepting healthy volunteers
NCT03969004
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Inclusion Criteria:
High risk cutaneous squamous cell carcinoma
Post resection and curative intent post-operative Radiation Therapy within 2 to 6 weeks of randomization
Adequate hepatic, renal, and bone marrow function as defined in the protocol
Exclusion Criteria:
Patients with blood cancer (hematologic malignancies) or other malignancies
Squamous cell carcinomas (SCCs) arising in non-cutaneous sites as defined in the protocol
Significant autoimmune disease that required treatment with systemic immunosuppressive treatments (including corticosteroids)
Has had prior systemic anti-cancer immunotherapy for cutaneous squamous cell carcinoma
Cancer
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Hershey, PA