Search Results
Maintenance Obinutuzumab for primary central nervous system lymphoma complete or partial responders
The study will compare participants with primary central nervous system lymphoma which responded to initial treatment and are thereafter treated with Obinutuzumab (the study drug), with participants with primary central nervous system lymphoma which responded to initial treatment and are not treated with the study drug.
In addition to your routine care, you will be “randomized” into one of the study groups described below. You will have a MRI of your brain approximately every three months (plus or minus two weeks) for two years. You will undergo a neurocognitive assessment and complete a quality-of-life questionnaire two years after study entry. Group A – Obinutuzumab Arm If you are in the first group ("Group A") you will be given the study drug every two months for two years. Every two months you will have your vital signs taken, your blood drawn (one to two tablespoons), and you will be given the study drug through an IV infusion into your vein. Group B – No Obinutuzumab Arm If you are in the second group ("Group B") every six months you will have your vital signs taken and your blood drawn (one tablespoon).
Must have undergone first-line treatment with high-dose methotrexate-based chemotherapy regimen with or without brain radiotherapy
Must be within 75 days of completion of first-line treatment regimen at the time of randomization
18 years or older
Clinical evidence of extra-CNS (systemic) non-Hodgkin lymphoma.
Known hypersensitivity to any of the study drugs.
History of other malignancy that could affect compliance with the protocol or interpretation of results
Known active bacterial, viral, fungal, mycobacterial, or other infection or any major episode of infection requiring treatment with IV antibiotics or hospitalization
NRG-GI008 Colon Adjuvant Chemotherapy based on Evaluation of Residual Disease (CIRCULATE-US) (22-070)
To compare time to ctDNA (+ve) status in ctDNA (-ve) cohort following resection of stage III colon cancer treated with immediate vs delayed (based on serial ctDNA surveillance) chemotherapy. Time to positive event is defined as time from randomization to the first ctDNA positive result for the immediate arm (Arm 1) and to the 2nd ctDNA positive result for the delayed arm (Arm 2) to allow for the potential effect of delayed adjuvant chemotherapy. Patients recurred without a positive ctDNA result will be considered to have ctDNA positive status at the time of recurrence for both study arms.
We are asking you to take part in this research study because you have colon cancer that has been treated with surgery but has spread to some of your lymph nodes and is known as stage III colon cancer. Or, you have stage II or stage III colon cancer with a higher risk of cancer returning, your colon cancer has been treated with surgery, and you had ctDNA testing done and are ctDNA positive. Stage II colon cancer is an early stage colon cancer that has been treated with surgery but has not spread to your lymph nodes. ctDNA, or circulating tumor DNA, is DNA that has been released from tumor cells into your bloodstream. This DNA can be measured using a blood test.
Hemoglobin must be ≥ 9 g/dL
HIV-infected patients on effective anti-retroviral therapy with undetectable viral load within 6 months
The treating investigator must deem the patient a candidate for all potential agents used in this trial (5FU, LV, oxaliplatin and irinotecan)
The patient must have an ECOG performance status of 0 or 1
Tumor-related bowel perforation
Synchronous primary rectal and/ or colon cancers
Active seizure disorder uncontrolled by medication
Active or chronic infection requiring systemic therapy
S1914 Randomized Phase III Atezolizumab + SBRT vs SBRT alone in high risk, early stage NSCLC (22-025)
To compare overall survival (OS) in patients with inoperable, early stage non-small cell lung cancer (NSCLC) randomized to stereotactic body radiation therapy (SBRT) with or without atezolizumab.
Patients will need to keep all of their radiation treatment appointments and keep all appointments with the study doctor. Patients will be expected to complete questionnaires and have extra blood samples taken at specific time point throughout the study.
Age ≥ 18
ECOG performance status of 0 or 1 within 180 days prior to registration;
Pretreatment serum PSA, obtained prior to any androgen suppression therapy and within 180 days of 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
Definitive clinical or radiologic evidence of metastatic disease
Pathologically positive lymph nodes or nodes > 1.5 cm short axis on CT or MR imaging
HIV positive with CD4 count < 200 cells/microliter
Prior radical prostatectomy, cryosurgery for prostate cancer, or bilateral orchiectomy for any reason
NMTRC012: PEDS-PLAN – Pediatric Precision Laboratory Advanced Neuroblastoma Therapy
A study of the safety and feasibility of using molecularly guided therapy in combination with standard therapy followed by maintenance therapy with DFMO in patients with newly diagnosed high risk neuroblastoma.
Participating in this study requires that you visit the study hospital Penn State Hershey Medical Center multiple times over the course of the full study for evaluations (physical exam, blood draw, urine analysis, etc.) and scans (MRI/CT, MIBG). Weekly visits may occur at your home institution with your home treating oncologist. As a subject in this clinical trial you are expected to receive treatment on this phase of the study for a total of about 2 ½ years if you complete all portions. After treatment, you will have follow-up examinations and medical tests.
Must be 21 years of age or younger when diagnosed.
No prior systemic therapy with some exceptions.
Tumor samples will be obtained only in a non-significant risk manner and not solely for the purpose of the study.
Female patients who are lactating are not eligible unless they agree not toe breast feed.
PSCI 22-141 CCTG MA.39
To compare the breast cancer recurrence-free interval (BCRFI) between patients that received regional RT or not, defined as time from randomization to time of invasive recurrent disease in the ipsilateral chestwall, breast, regional nodes, distant sites or death due to BC.
Women with low risk breast cancer will be randomized to either regional radiation therapy or no regional breast radiation therapy. Patients will be expected to keep all of their radiation appointment and complete all questionnaires.
Patients must have been treated by BCS or mastectomy with clear margins of excision*.
Patients with T3N0 disease are eligible.
Patients with disease limited to nodal micrometastases are eligible.
Patients must be ER ≥ 1% and HER2 negative on local testing
Patients with pT3N1 and pT4 disease
Any prior history, not including the index cancer, of ipsilateral invasive breast cancer or ipsilateral DCIS treated with radiation therapy
Synchronous or previous contralateral invasive breast cancer.
Patients who are pregnant.
A Phase III De-escalation of Breast Radiation for Stage I, Hormone Sensitive, HER2 Negative Breast Cancer (PSCI# 21-098) (NRG-BR007)
This study is being done to answer the following question: Is treatment with hormonal therapy as good as the usual treatment of radiation and hormonal therapy in women with low-risk breast cancer who have had lumpectomy? We are doing this study because we want to find out if this approach is better or worse than the usual approach for your breast cancer. The usual approach is defined as care most people get for low-risk, early stage breast cancer that is sensitive to hormones.
Pt will either have radiation therapy to the breast and take a hormonal drug for at least five years or you will only take a hormonal drug for at least five years.
The patient must have recovered from surgery with the incision completely healed and no signs of infection
The patient must have an ECOG performance status of 0 or 1
The tumor must be unilateral invasive adenocarcinoma of the breast on histologic examination
The tumor must have been determined to be HER2-negative by current ASCO/CAP guidelines
pT2 - pT4 tumors including inflammatory breast cancer
Patient had a mastectomy
Non-epithelial breast malignancies such as sarcoma or lymphoma
Paget's disease of the nipple
PSCI 24-077 A Phase 1b/2 Study Assessing the Safety and Efficacy of Evexomostat (SDX-7320) in Combination with a PI3K Pathway Inhibitor plus Fulvestrant in Postmenopausal Women with Advanced Breast Cancer and PI3K Pathway Alterations Who Have Progressed on or Following Endocrine Therapy plus a CDK4/6 Inhibitor
this trial is looking at introducing a medication to control blood sugars elevations caused by CDK inhibitors.
Participants must agree to come to all study visits, report any new medications to the study team, agree to having blood work done at least 8-12 hours after eating something, take study medication as directed.
Patient with histologically and/or cytologically confirmed diagnosis of HR+, HER2- breast cancer, as determined by the local laboratory.
Patient has identified PI3K pathway
Patient has locally advanced (not amenable to curative therapy or metastatic) breast cancer meeting any of the following categories:
Patient has measurable disease
Patient has known primary brain malignancy,
Patient has a known hypersensitivity to evexomostat, fulvestrant, alpelisib or capivasertib, or to any of their excipients.
Patient has had major surgery within 30 days
Patient has uncontrolled human immunodeficiency virus (HIV) infection.
PSCI 23-012 THE JANUS RECTAL CANCER TRIAL: A RANDOMIZED PHASE II TRIAL TESTING THE EFFICACY OF TRIPLET VERSUS DOUBLET CHEMOTHERAPY TO ACHIEVE CLINICAL COMPLETE RESPONSE IN PATIENTS WITH LOCALLY ADVANCED RECTAL CANCER
This trial is using long course chemoradiation in combination with three different chemotherapy treatments to treat rectal cancer. Once therapy is completed patients will either have surgery or watch and wait. The goal is to see which therapy is better in achieving a complete response, if any.
Patients will be expected to come to the clinic for all radiation treatments and all chemotherapy treatments.
Tumor Site: Rectum; ≤ 12cm from the anal verge
No prior systemic chemotherapy, targeted therapy, or immunotherapy; or radiation therapy administered as treatment for colorectal cancer within the past 5 years is allowed.
Not pregnant and not nursing,
Age ≥ 18 years
No recurrent rectal cancer; prior transanal excision, prior distal sigmoid cancer with a low anastomosis
No known mismatch repair deficient rectal adenocarcinoma
Phase III Trial of MEDI4736 (durvalumab) as Concurrent and Consolidative Therapy or Consolidative Therapy Alone for Unresectable Stage 3 NSCLC (EA5181) (PSCI# 21-041)
The purpose of this study is to compare the usual approach of chemo/radiation followed by one year of MEDI4736 (durvalumab) to chemo/radiation with MEDI4736 (durvalumab) followed by one year of MEDI4736 (durvalumab). The addition of MEDI4736 (durvalumab) during chemo/radiation could prevent your cancer from returning and extend your life. But, it could also cause side effects. This study will help the study doctors find out if this different approach is better, the same, or worse than the usual approach. To decide if it is better, the study doctors will be looking to see if the study drug extends the life of patients and/or prevents the tumor from coming back as compared to the usual approach. This drug, MEDI4736 (durvalumab), is already approved by the FDA for use in other cancers, and for use in your type of cancer after the completion of chemotherapy and radiation. At this time MEDI4736 (durvalumab) is not yet approved (experimental) when given with chemotherapy and radiation. There will be about 660 people taking part in this study.
The purpose of this study is to compare the usual approach of chemo/radiation followed by one year of MEDI4736 (durvalumab) to chemo/radiation with MEDI4736 (durvalumab) followed by one year of MEDI4736 (durvalumab). The addition of MEDI4736 (durvalumab) during chemo/radiation could prevent your cancer from returning and extend your life. But, it could also cause side effects. This study will help the study doctors find out if this different approach is better, the same, or worse than the usual approach. To decide if it is better, the study doctors will be looking to see if the study drug extends the life of patients and/or prevents the tumor from coming back as compared to the usual approach. This drug, MEDI4736 (durvalumab), is already approved by the FDA for use in other cancers, and for use in your type of cancer after the completion of chemotherapy and radiation. At this time MEDI4736 (durvalumab) is not yet approved (experimental) when given with chemotherapy and radiation. There will be about 660 people taking part in this study.
Patient must have an ECOG Performance Status of 0 or 1.
Body weight > 30 kg of patients.
Patient must not have unintentional weight loss > 10% within 30 days prior to registration.
Patient must have a baseline ECG obtained within 6 weeks of registration.
Patient must not have a history of active hepatitis B (chronic or acute) or hepatitis C infection.
Patient must not have a known active tuberculosis infection.
Patient must not have any severe infections within 4 weeks prior to registration including, but not limited to, hospitalization for complications of infection, bacteremia, or severe pneumonia.
Patient must not have signs or symptoms of severe infection (sepsis) within 2 weeks prior registration.
A multicenter safety study of unlicensed, investigational cryopreserved cord blood units (CBUs) manufactured by the National Cord Blood Program (NCBP) and provided for unrelated hematopoietic stem cell transplantation of pediatric and adult patients
Study of the safety of unlicensed cord blood units for stem cell transplant of children and adults.
For the treatment arm of this study you will no receive the total body radiation (TBI) as typically given before transplant. In this study you will have various research procedures such as a Blast sample at the screening part of the study, and MRD testing of your bone marrow and blood at screening and through the course of the study. Participation in the treatment arm (Non-TBI) of the study will last up to 5 years.
You are receiving unlicensed CB products from other CB banks
A151216-Adjuvant Lung Cancer Enrichment Marker Identification and Sequencing Trial (Alchemist)
Purpose of study is to examine lung cancer patients' surgically removed tumors for certain genetic changes and to possibly refer these patients to a treatment study with drugs that may specifically these tumors.
Patients will be registered to the trial after surgical intervention. One vial of peripheral blood and a tissue block (or scrolls) will be submitted to the study. Once testing is completed, subject is notified if they are eligible for one of the sub protocols.
Pathologic stage IIIA, II (IIA or IIB) or large IB (defined as size ≥4 cm).
Tissue available for the required analyses
No prior treatment with agents targeting EGFR mutation, ALK rearrangement, and PD1/PD-L1/CTLA-4.
Genetics of Aromatase Inhibitor Musculoskeletal Syndrome (AIMSS)
This is a case-control biospecimen collection study of 1,000 breast cancer patients with survey and retrospective chart review components to study the possible genetic, clinical and demographic/lifestyle predictive factors of AIMSS.
If you decide to participate, we will ask you to send us a sample of your saliva (“spit”) and ask you to fill out a survey on a computer or on paper, whichever you prefer. The survey will ask questions about risk factor data, demographics, and questions about side effects of cancer treatments. We will also ask you for permission to collect data from your electronic medical record.
$25
Prescribed at least one AI as part of breast cancer treatment at least one year ago
Female aged 21 and older
English or Spanish speaking
Diagnosis and systemic chemotherapy and/or hormonal treatment from cancer diagnosed prior to the index breast cancer
Those currently incarcerated
Under age 21 years old
PSCI: 24-010: Evaluate Safety and Efficacy of Daily oral Angelica gigas Nakai (AGN)-INM176 in Prostate Cancer Patients with Rising Plasma PSA (Phase I/II trial)
The purpose of this voluntary research study is to evaluate the safety and assess the efficacy of the daily INM176 herbal supplement in managing prostate cancer-specific PSA levels in prostate cancer patients.
This research study involves two phases: Phase I and Phase II. The procedures and treatments may vary depending on the phase the participant is in. Study Drug is administered daily by mouth. Pharmacokinetic (PK) and Pharmacodynamic (PD) blood tests are research procedures. Other research procedures include physical exams, vital signs, and blood tests.
Phase I Total: $1,200. Phase II Total: $1,300. Phase II Subjects crossing over from Phase I: Total: $900. All phases: Each additional unscheduled visit will be compensated for $100.
Male aged >=40 years.
History of prostate cancer diagnosis
Subjects with treated prostate cancer are eligible.
ECOG performance status 0-2.
Any active secondary malignancy requiring treatment.
Chronic kidney disease with calculated GFR <30 mL/min/1.73 m2 using Cockcroft-Gault formula, or measured GFR <30 mL/min/1.73 m2 using a 24-hour urine collection.
Subjects who are taking Warfarin/coumadin.
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.
Participants will be required to come to the clinic every three weeks for evaluation and fulvestrant injections, take medication correctly, keep all appointments.
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
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.
PSCI 24-018 Phase 1, open label clinical trial to treat Stage IV cancer patients with multiple patient-specific mutated cell surface proteins with chimeric antibodies
This study will examine if giving patients their cells that have been modified in the lab will help control their cancer.
Subjects will be required to come to all visits. Each treatment will take 2-5 hours and there will be a total of 10 treatments over a 14 week period.
Subjects who have refractory or progressive disease after at least 1 line of systemic treatment
Subjects must have measurable disease
Known human immunodeficiency virus infection.
Subjects who have received any cytotoxic treatment within 3 weeks of antibody treatment.
Subjects who have received any radiotreatment to the primary sample site within the last 14 days
PARPAML: A Phase 1 Protocol for Relapsed Pediatric AML to Determine the Safety and Efficacy of the PARP Inhibitor Talazoparib in Combination with Chemotherapy
The purpose of this study is to find out what effects, good and/or bad, study treatment with talazoparib in combination with the chemotherapy drugs topotecan and gemcitabine has on pediatric patients with acute myeloid leukemia (AML) that has returned or has not responded to treatment. The study drug talazoparib has been chosen because there is evidence that is can reduce tumor activity in a more specific way than chemotherapy.
If you join the study, you will given a certain dose of the study drug talazoparib, and of the chemotherapy drugs topotecan and gemcitabine. You may be asked to provide biological samples (such as blood or bone marrow) and undergo procedures that might be different from a regular medical examination. This study will involve screening, treatment, and follow up period. During screening, the study doctor will determine whether you are eligible for the study. If you are eligible and are enrolled into the study, you will have 2-3 months of active participation, including collection of information from you, admission to the hospital for a minimum of 5-7 days, and at least weekly visits to the study center.
PSCI 24-127 EXActDNA-003: Breast Cancer Clinical Validation Study to Predict Recurrence of High-Risk Early Breast Cancer Treated with Neoadjuvant Therapy Using a Bespoke Circulating Tumor DNA Assay to Detect Molecular Residual Disease (NSABP B-64)
This study will be using a test called Oncodetect to identify specific gene mutations. These may help in predicting the risk of the cancer coming back.
Subjects will need to agree to come to the hospital for 14 visits to have blood drawn.
$375.00
ECOG performance status 0 or 1.
Histologically confirmed invasive carcinoma of the breast.
Planned neoadjuvant therapy which includes cytotoxic chemotherapy.
Tumor size ≥ 2.1 cm in greatest diameter.
Initiated neoadjuvant therapy for current breast cancer diagnosis.
diagnosis of another invasive cancer
Known pregnancy at time of enrollment.
BCC022: Phase II Trial of Tipifarnib and Naxitamab for Relapsed/Refractory Neuroblastoma
The purpose of this research is to evaluate the investigational drug, tipifarnib (a pill taken by mouth), in combination with the FDA approved drug, naxitamab, administered intravenously (IV; a liquid that continuously goes into your body through a tube that has been placed during a surgery into one of your veins).
You will be asked to come in for screening and at the start of each cycle (every 28 days), and at the end of study treatment to have tests done (these may include a physical exam, blood tests, and electrocardiogram [ECG]). During the first cycle you will need to have blood tests done weekly. You will also need to come in during Days 1-5 of each cycle to receive the study treatment. You will also have scans and a bone marrow biopsy (tissue sample) and aspirate (fluid and cells) done at the start of study, every 2 cycles, and at the end of study.
Age >12 months of age at enrollment
Age 6 years or older for safety run in
Currently receiving another investigational drug
PSCI# 24-014 OPTIMICE-PCR: DE-ESCALATION OF THERAPY IN EARLY-STAGE TNBC PATIENTS WHO ACHIEVE PCR AFTER NEOADJUVANT CHEMOTHERAPY WITH CHECKPOINT INHIBITOR THERAPY
this trial is examining what happens if a less toxic therapy is given to triple negative breast cancer subjects who's tumor is completely gone after receiving pre surgery chemotherapy.
Participants will need to come to all research visits, reports any side effects of medication, if they are taking any over the counter medications.
ECOG Performance Status 0-2
Triple Negative Breast Cancer
Patients must have received neoadjuvant chemotherapy in combination with pembrolizumab for a minimum of 6 cycles. All systemic chemotherapy must have been completed preoperatively.
An interval of no more than 12 weeks between the completion date of the final surgery and the date of randomization.
No history of any prior (ipsi- or contralateral) invasive breast cancer. Prior DCIS is allowed.
No evidence of recurrent disease following preoperative therapy and surgery.
No known active liver disease, e.g. due to HBV, HCV, autoimmune hepatic disorders, or sclerosing cholangitis
A Phase II/III Study of Maintenance Nivolumab versus Observation in HPV Positive OPCA (PSCI# 20-016) (EA3161)
The purpose of this study is to compare the usual treatment alone (radiation and chemotherapy) to adding maintenance nivolumab to the usual treatment. The addition of nivolumab to the usual treatment could shrink your cancer or prevent it from 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 than the usual approach. To decide if it is better, the study doctors will be looking to see if the nivolumab increases the lifetime of the patient without progression for 10 years. This immunotherapy drug, nivolumab, is already approved by the FDA for use in advanced and incurable head and neck cancer. But, most of the time it is not used until the cancer is very advanced and chemotherapy stops working. In this study we believe the use of nivolumab has a chance of preventing the cancer from coming back for patients with your type of cancer. There will be about 286 people taking part in the first part (phase II) of the study and 458 more people taking part in second part (phase III), if the results of the phase II portion are promising and if there is evidence that nivolumab may prolong your life.
The purpose of this study is to compare the usual treatment alone (radiation and chemotherapy) to adding maintenance nivolumab to the usual treatment.
ECOG performance status of 0 or 1.
Patients must have oropharynx cancer that is p16-positive by immunohistochemistry
Adequate baseline organ and marrow function
Adequate baseline liver functionality
Patients must not have had prior systemic therapy or radiation treatment for p16 positive OPSCC
Patients must not have received previous irradiation for head and neck, tumor, skull base, or brain tumors
Patients must not have known hypersensitivity to nivolumab
Patients with evidence of distant metastases or leptomeningeal disease are excluded
Strengths, Outcomes, Adversity, and Resilience in College-Aged Childhood Cancer Survivors: The PSU SOAR Study
The purpose of this study is to analyze the strengths, outcomes, adversity, and resilience, as indicated by self-reported experiences in college students who may or may not be childhood cancer survivors. We are asking college students aged 18-23 years attending 4 year universities in the United States to report on their childhood health experiences and their current mental, physical, and social well being during college using a confidential survey. We plan to recruit students who have or have not had a childhood history of cancer and will also ask questions about their demographic information and health habits.
The participants will be asked to complete a confidential online survey that will take 10-15 minutes to complete.
Participants are eligible to earn a $75 Amazon gift card through a random drawing that they can choose to enter after submitting their survey responses
College student attending 4 year university
English as primary language
Not attending a 4 year university
Does not have English as primary language
PSCI #24-126 A Phase III Trial Of Perioperative Versus Adjuvant Chemotherapy For Resectable Pancreatic Cancer.
This study is for subjects who have removable pancreatic cancer. If subjects decide to take part in this study, subjects will either get the study drugs FOLFIRINOX for about 4 months followed by surgery and then more FOLFIRINOX for about 2 months, or subjects will get surgery followed by FOLFIRINOX for about 6 months. After subjects finish their treatment, the subject's doctor will continue to watch them for side effects. They will check subjects in the clinic every 4 months for 2 years after you started the study. After that, they will check subjects either in the clinic or by phone every 6 months for 6 years after the subject started the study. This means that the subject will keep seeing or hearing from their doctor for 6 years after they started the study.
Subject will either get the study drugs FOLFIRINOX for about 4 months followed by surgery and then more FOLFIRINOX for about 2 months, or the subjects will get surgery followed by FOLFIRINOX for about 6 months. After treatment the doctor will continue to watch for side effects. They will check on the subjects in the clinic every 4 months for 2 years after the subject started the study. After that, they will check the subject either in the clinic or by phone every 6 months for 6 years after you started the study. This means that the subject will keep seeing or hearing from your doctor for 6 years after you started the study.
No evidence of metastatic disease
Less than 180° interface between tumor and vessel wall of the portal vein or superior mesenteric vein, and patent portal vein/splenic vein confluence
No involvement or abutment of the celiac artery, common hepatic artery, superior mesenteric artery, or replaced right hepatic artery (if applicable)
Age ≥ 18 years
comorbid conditions that would prohibit curative-intent pancreatectomy
ECOG Performance Status greater than 0-1
PSCI 23-144 NRG-LU008: PHASE III PROSPECTIVE RANDOMIZED TRIAL OF PRIMARY LUNG TUMOR STEREOTACTIC BODY RADIATION THERAPY FOLLOWED BY CONCURRENT MEDIASTINAL CHEMORADIATION FOR LOCALLY ADVANCED NON-SMALL CELL LUNG CANCER
Patients diagnosed withy inoperable node positive non small cell lung cancer will be randomized to with radiation therapy to all know sites of disease in the lung, followed by immunotherapy or radiation to the primary lung tumor, followed by radiation to the lymph nodes followed by immunotherapy
Participants will be required to come to all study visits, report to the study doctor any new medications, prescription or over the counter that they may be taking,
The patient must be deemed clinically appropriate for curative intent definitive combined modality therapy, based on the following staging assessments:
No evidence of distant metastases based on FDG PET/CT scan obtainedwithin 60 days of registration.
Primary tumor ≤ 7 cm;
Age ≥ 18;
Patients without identifiable primary tumor
Centrally located primary tumor < 2 cm from involved nodal disease which would result in significant overlap of the primary SBRT and nodal radiation fields
Participants who are pregnant or unwilling to discontinue nursing.
Participants of childbearing potential (participants who may become pregnant or who may impregnate a partner) unwilling to use highly effective contraceptives during therapy
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.
Blood will be drawn at two time points and number of visits will be determined by the individual radiation treatment plan.
No evidence of metastasis
1 - 3 positive lymph nodes
May have had breast conserving surgery or mastectomy
35 years of age or older
History of ipsilateral breast cancer or DCIS
Synchronous or contralateral breast cancer
pT4 disease
Neoadjuvant Chemotherapy for breast cancer
A Confirmatory Phase 3 Mutlicenter, Randomized, Double-Blind, Placebo-Controlled Study of the Efficacy of Topical HyBryte (Hypericin Sodium) and Visible-Light Activation for the Treatment of Cutaneous T-Cell Lymphoma (CTCL).
The purpose of this trial is to evaluate the safety and efficacy of 18 weeks of HyBryte (topical gel) treatment in combination with visible light therapy in subjects with cutaneous T-cell lymphoma when compared to placebo (no active ingredient). Cutaneous T-cell lymphoma (CTCL), of which the most common early stages are also known as mycosis fungoides (MF), is the most common type of T cell lymphoma. Participants will be enrolled in this trial for 30 weeks and will follow up at the clinic site every 4 weeks following the last trial treatment for a total of 12 weeks.
Participants will attend in person visits over 30 weeks. At different timepoints throughout the study participants will have their skin evaluated and photographed, have blood drawn, have an ECG done, and apply the study medication as directed by the study team.
Participants must have a minimum of 3 evaluable, discrete lesions
Participants must be willing to follow the clinical protocol and voluntarily give their written informed consent
Participants with extensive skin disease may not be eligible to participate; investigator will discuss during skin evaluation
Certain medical conditions may not be eligible to participate; study coordinator will discuss further.
Genomic Profiling of Urothelial Cancers Study
The objective of this protocol is to study urothelial cancer with detailed health history, tumor and/or normal tissues available for genomic sequencing to study cancers in the bladder, upper urinary tract, and urethra. There will be 3 groups of subjects in this study: 1) Urothelial cancer patients receiving care at Penn State Health 2) Relatives of patients with urothelial cancer 3) High risk-cohort of individuals with family history of urothelial cancers or inherited cancer syndromes (such as Lynch syndrome) candidates for urothelial cancer screening evaluation
All subjects will be asked to fill out questionnaires to assess risk factors for urinary cancer and document family history of cancer. You will be asked to provide a blood sample and urine sample for genetic testing. Patients with urothelial cancer will be asked to allow us to test leftover tissue from a past or future biopsy to test cancer and/or normal cells for certain mutations. We may also ask you for a saliva sample, cheek swab, skin biopsy, or nail clippings for comparison.
personal or family history of bladder cancer
PSCI 22-120 A Randomized, Double-Blind, Placebo-Controlled Study to Determine the Efficacy and Safety of AAV2-hAQP1 Gene Therapy in Participants with Radiation-Induced Late Xerostomia
This trial will be comparing two doses of AAV2-hAQP1 against a placebo for patients with head and neck cancer who have severe dry mouth from receiving radiation.
Patient's will be required to come to all study visits, reports any signs and symptoms they are having and all medications they are taking. You will be required to come in for 2 pre screening visits that will include signing the consent, collecting of saliva, completing questionnaires, seeing the study doctor, having blood drawn, providing a urine specimen to see if you qualify to participate. If you meet the qualifications to participate you will have one visit in which you will receive medication to dry your mouth, than the study doctor will place the medication into the glands in your mouth that produce saliva. You will then be requires to come in the next week for additional saliva collection and to see the study doctor. After that you will come in monthly to see the study doctor too see how you are feeling,complete questionnaires and provide a urine specimen.
dependent upon miles traveled
Age ≥18 years
Able to understand the investigational nature, potential risks, and benefits of the study, and to provide valid informed consent to enroll in this study and in the long-term follow-up study
Completed beam radiation therapy for head and neck cancer at least 3 years prior to the first screening visit
No history of recurrent cancer or a second primary cancer
Any experimental therapy within 3 months prior to the first screening visit
Previous treatment with a gene or cell therapy
History of systemic autoimmune disease affecting the salivary glands (e.g., Sjogren’s disease)
Currently using systemic immunosuppressive medication(s)
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.
Radiation treatment and hormonal therapy vs. Radiation treatment, hormonal therapy plus Enzalutamide in post-prostatectomy cancer recurrences
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
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
A082002 Randomized Phase II/III of immunotherapy with or without SBRT PD-L1 negative NSCLC (22-026)
To assess if SBRT improves the progression free survival (PFS, phase II portion) and overall survival (OS, phase III portion) of advanced stage NSCLC patients with PD-L1 TPS <1% who receive immunotherapy with or without chemotherapy
We are asking you to take part in a research study. This study has public funding from the National Cancer Institute (NCI), part of the National Institutes of Health (NIH) in the United States Department of Health and Human Services. We do research studies to try to answer questions about how to prevent, diagnose, and treat diseases like cancer.
No prior systemic chemotherapy or immunotherapy for advanced NSCLC
Not pregnant and not nursing
No known history of Hepatitis B or Hepatitis C
Platelet Count ≥ 100,000/mm3
Current pneumonitis or history of non-infectious pneumonitis that required steroids
Prior allogeneic tissue/solid organ transplant.
Age < 18 years
ECOG Performance Status over 3
Randomized Phase II/III Trial of Radiation with High-Dose Cisplatin (100 mg/m2) Every Three Weeks versus Radiation with Low-Dose Weekly Cisplatin (40 mg/m2) (PSCI# 21-207) (NRG-HN009)
The purpose of this study is to compare two usual treatment approaches to your head and neck cancer: high-dose cisplatin given every 3 weeks with radiation to low-dose cisplatin given weekly with radiation. The first part of this study will help the study doctors find out if the low-dose cisplatin approach is better tolerated than the high-dose cisplatin approach. To decide if it is better, the study doctors will be looking to see if there are fewer side effects for patients who receive low-dose cisplatin weekly compared to patients who receive high-dose cisplatin every 3 weeks. The second part of this study will also help the study doctors find out if the low-dose cisplatin approach will extend your life by at least the same amount of time as the high-dose cisplatin approach. There will be 464 people in the first part of the study. If the study goes on to the second part, there will be 786 additional people. Overall, there will be a total of up to 1250 people taking part in this study.
he first part of this study will help the study doctors find out if the low-dose cisplatin approach is better tolerated than the high-dose cisplatin approach. To decide if it is better, the study doctors will be looking to see if there are fewer side effects for patients who receive low-dose cisplatin weekly compared to patients who receive high-dose cisplatin every 3 weeks. The second part of this study will also help the study doctors find out if the low-dose cisplatin approach will extend your life by at least the same amount of time as the high-dose cisplatin approach. There will be 464 people in the first part of the study. If the study goes on to the second part, there will be 786 additional people. Overall, there will be a total of up to 1250 people taking part in this study.
Age ≥ 18
Zubrod (ECOG) performance status of 0-1 within 14 days prior to registration
Adequate hematologic function within 30 days prior to registration
Adequate renal function within 30 days prior to registration defined as calculated creatinine clearance (CrCl) ≥ 50 mL/min by the Cockcroft-Gault formula
Definitive clinical or radiologic evidence of distant metastatic disease
Prior systemic chemotherapy for the study cancer; note that prior chemotherapy for a different cancer is allowable, however, any prior exposure to cisplatin is excluded
Prior radiotherapy to the region of the study cancer that would result in overlap of radiation therapy fields
Pregnancy and individuals unwilling to discontinue nursing