Search Results Within Category "Cancer"
A Phase 3 Multicenter, Randomized, Double-blinded, Active-controlled, Clinical Study to Evaluate the Safety and Efficacy of Lenvatinib (E7080/MK-7902) with Pembrolizumab (MK3475) in Combination with Transarterial Chemoembolization (TACE) Versus TACE in Participants with Incurable/Non-metastatic Hepatocellular Carcinoma (LEAP-012)
This is a study that will compare a study drug pembrolizumab plus a study drug lenvatinib in combination with the therapy called TACE (transarterial chemoembolization) which is a way to deliver chemotherapy locally through a procedure called embolization and how that works versus placebo (or no study medications) plus TACE and how it could lead to progression-free survival (PFS).
This is a study that will compare a study drug pembrolizumab plus a study drug lenvatinib in combination with the therapy called TACE (transarterial chemoembolization) which is a way to deliver chemotherapy locally through a procedure called embolization and how that works versus placebo (or no study medications) plus TACE and how it could lead to progression-free survival (PFS).
Has HCC localized to the liver without portal vein thrombosis, and not amenable to curative treatment such as resection, ablation, or liver transplant.
Has at least one measurable HCC lesion based on RECIST 1.1,
Has an ECOG performance score of 0 to 1
Has a predicted life expectancy of >3 months.
Has had esophageal or gastric variceal bleeding within the last 6 months.
Has clinically apparent ascites on physical examination that is not controlled with medication
Has had clinically diagnosed hepatic encephalopathy in the last 6 months unresponsive to therapy.
Has clinically significant hemoptysis from any source or tumor bleeding within 2 weeks prior
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
SENTINEL LYMPH NODE BIOPSY VERSUS ELECTIVE NECK DISSECTION FOREARLY-STAGE ORAL CAVITY CANCER (NRG-HN006) (PSCI# 20-085)
The purpose of this study is to see if neck and shoulder function and pain are better after SLN biopsy surgery compared to the usual approach and to see if SLN biopsy surgery is as good as the usual approach in extending your time without cancer. SLN biopsy surgery is potentially less invasive compared to the usual approach, but it requires a radioactive imaging agent to see the lymph nodes and it could also cause side effects. These side effects are described in the risks section below. Your study doctor will choose the appropriate imaging agent, Lymphoseek or sulfur colloid, for use in your surgery.This study will help the study doctors find out if this different approach is better than the usual approach at improving neck and shoulder function. To decide if it is better, in the first part of the study, doctors will be looking to see if shoulder and neck function and quality of life are better after SLN biopsy surgery compared to the END surgery.
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. We are asking you to take part in this research study because you have early-stage oral cavity cancer and are having neck dissection surgery.
Age ≥ 18
Zubrod Performance Status 0-2 within 42 days prior to registration
Only English speaking patients (able to read and understand English) are eligible to participate as the mandatory patient reported NDII tool is only available in this language
For women of child bearing potential, negative serum or urine pregnancy test within 42 days prior to registration
Prior systemic chemotherapy for the study cancer; note that prior chemotherapy for a different cancer is allowable
Patient with severe, active co-morbidity that would preclude an elective or completion neck dissection
Incomplete resection of oral cavity lesion with a positive margin; however, an excision biopsy is permitted
Actively receiving systemic cytotoxic chemotherapy, immunosuppressive, anti-monocyte or immunomodulatory therapy.
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: “Tailor RT: A Randomized Trial of Regional Radiotherapy in Biomarker Low Risk Node Positive and T3N0 Breast Cancer
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 Randomized, Open Label Phase 3 Study Evaluating Safety and Efficacy of Venetoclax in combination with Azacitidine after allogeneic Stem Cell Transplantation in Subjects with Acute Myeloid Leukemia (AML)(M19-063)
This study is to determine the recommended Phase 3 dose of venetoclax in combination with azacitidine in Acute Myeloid Leukemia patients when given as maintenance therapy following allogeneic stem cell transplantation. It also is to determine if venetoclax can be effective in combination with azacitidine to improve Relapse Free Survival in Acute Myeloid Leukemia patients compared to Best Supportive Care (BSC) when given as maintenance therapy following allogeneic stem cell transplantation.
There are different phases of this study. The first phase is Screening, then there is the Treatment phase as well as a Follow up phase. Each phase will have testing and procedures that will require you to come to the study center.
50.00 Travel expenses
Subject must be diagnosed with Acute Myeloid Leukemia by World Health Organization (WHO) criteria (2017) and either be planning for allogeneic stem cell transplantation or have received allogeneic transplantation within the past 14 days.
Subjects that have previously been treated with venetoclax, can only be included if there was no history of disease progression during venetoclax treatment.
Grafts must be from one of the following sources: Bone marrow or peripheral blood stem cells or cord blood cells irrespective of degree of matching.
Subjects and/or their legally authorized representative (where permitted per local regulations) must voluntarily sign and date an informed consent form (and assent form for minors if required by applicable regulations)
No history of any other malignancy within 2 years prior to study entry
Subject has no known evidence indicating leukemia relapse, which may include immunophenotype, cytogenetic or molecular methods.
No psychiatric illness/social situation that would limit compliance with the study.
No evidence of other clinically significant uncontrolled systemic infection.
PSCI 22-132 A Dose-Escalation and Expansion Study of the Safety and Efficacy of XL092 in Combination With Immuno-Oncology Agents in Subjects With Unresectable Advanced or Metastatic Solid Tumors
The purpose of this voluntary research study is to evaluate potential new anticancer to treat people with tumors similar to yours. This study will provide information about the safety, the ability of your body to accept the study drug(s), the amount of study drug(s) and/or break-down products in your blood, and your body’s reaction to the study drug(s). Participants will be required to take study medication, have blood drawn, and have imaging tests such as CT, MRI, ECG, MUGA, ECHO, and bone scans.
Participants in the expansion stage will receive study treatment, imaging exams (ECHO, MUGA, ECG, CT, MRI, bone scans), blood draws, tumor assessments, and tumor tissue samples.
For all Expansion Cohorts except Cohort 3 (mCRPC): Measurable disease per RECIST
For Expansion Cohorts only: Archival tumor tissue material, if available, or fresh tumor tissue if it can be safely obtained.
Recovery to baseline or ≤ Grade 1 CTCAE v5 from AE(s) related to any prior treatments unless AE(s) are deemed clinically nonsignificant by the Investigator and/or stable on supportive therapy.
Age 18 years or older on the day of consent
Cohort 2 (ccRCC 2L), Cohort 3 (mCRPC), Cohort 5 (UC), Cohort 9 (NSCLC, 2L+), and Cohort 10 (CRC, 2L+): Receipt of any type of small molecule kinase inhibitor (including investigational kinase inhibitor) within 2 weeks before first dose of study treatment.
For Cohort 3 (mCRPC): Receipt of abiraterone within 1 week; cyproterone within 10 days; or receipt of flutamide, nilutamide, bicalutamide, enzalutamide, or other androgen receptor inhibitors within 2 weeks before first dose of study treatment.
Receipt of any type of anticancer antibody (including investigational antibody) or systemic chemotherapy within 4 weeks before first dose of study treatment.
Any complementary medications (eg, herbal supplements or traditional Chinese medicines) to treat the disease under study within 2 weeks before first dose of study treatment.
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
Phase 2 Study of Bladder-SparIng ChemoradiatioN with Durvalumab (PSCI# 19-072) (EA8185)
The purpose of this study is to compare the usual treatment of chemotherapy and radiation to adding MEDI4736 (durvalumab) immunotherapy to the usual treatment. The addition of MEDI4736 (durvalumab) immunotherapy to the usual treatment may help shrink your cancer better than the current standard of care or usual approach for bladder cancer. But, it could also cause side effects, which are described in the risks section.This study will help determine 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 study approach increases the life of patients by 6 months or more compared to the usual approach.
If you decide to take part in this study, you will either get chemotherapy and radiation for 6-8 weeks, or you will get durvalumab immunotherapy in addition to chemotherapy and radiation for 6.5-8 weeks. After you finish your study treatment, your doctor will continue to follow you for up to 3 years. The follow-up will consist of visits to his or her office and CT scans of the bladder.
Patient must have histologically proven pure or mixed urothelial cancer of the bladder.
Patient must be ≥ 18 years of age.
Must have adequate renal function as evidenced by calculated (Cockcroft’s formula) creatinine clearance or 24 hours actual creatinine clearance ≥ 30mL/min.
Patient must have a life expectancy of at least 12 weeks, as determined by the treating physician.
Patient must not have received any previous radiation therapy to the pelvic area.
Women must not be pregnant or breast-feeding due to the potential harm to an unborn fetus and possible risk for adverse events in nursing infants with the treatment regimens being used.
Patients with a negative biopsy of nodes determined to be suspicious on imaging are not eligible.
Small cell carcinoma is excluded, however other variant histologies are permitted provided a component of urothelial carcinoma is present.
A Phase 3 Randomized, Open-Label, Multicenter Study Evaluating the Efficacy of Axicabtagene Ciloleucel Versus Standard of Care Therapy in Subjects with Relapsed/Refractory Follicular Lymphoma
The purpose of this study is to determine how effective and safe axi-cel is compared to standard of care, specifically chemo-immunotherapies, and use this information to determine the best choice of treatment in Subjects with Relapsed/Refractory Follicular Lymphoma
Attend all study visits receive study drug or SOChave blood drawn for various testsECHO or MUGA, ECG, PET/CT, and MRI if neededbone marrow biopsy if neededComplete questionnaires
R/r disease as defined as one of the following options: a) First-line systemic chemoimmunotherapy and high-risk disease, defined as relapse or progression within 24 months of initiation of the initial course of chemoimmunotherapy (ie, POD24)
Clinical indication for treatment local symptoms due to progressive or bulky disease, systemic B symptoms, compromised organ function due to disease progression, cytopenias due to marrow involvement, or symptomatic extranodal disease.
At least 1 measurable lesion per the Lugano Classification
No known history or suspicion of central nervous system (CNS) lymphoma involvement
FL Grade 3b
Small lymphocytic lymphoma
Lymphoplasmacytic lymphoma
Full-thickness involvement of the gastric wall by lymphoma
PSCI 21-158 Radiopaque Hydrogel Rectal Spacer for Prostate Cancer Radiation Image Guidance
Prior to enrollment, potential subjects will be evaluated during the Screening Period to determine eligibility. The following assessments will be performed during the Screening Period:●Review of eligibility ●Placement of hydrogel spacer and fiducial marker after eligibility is determined Visit 2 or Day 2 or Post-test - Radiotherapy per standard of care.
Prior to enrollment, potential subjects will be evaluated during the Screening Period to determine eligibility. The following assessments will be performed during the Screening Period:●Review of eligibility ●Placement of hydrogel spacer and fiducial marker after eligibility is determinedVisit 2 or Day 2 or Post-test - radiotherapy per standard of care
N/A
N/A
N/A
N/A
Prior prostate surgery
Prior prostate radiotherapy
N/A
N/A
Phase II Study of Bendamustine and Rituximab plus Venetoclax in Untreated Mantle Cell Lymphoma over 60 Years of Age
This study is to see if venetoclax in combination with bendamustine and rituximab chemotherapy is effective in treating people who have mantle cell lymphoma and to examine the side effects, good and bad, associated with this combination .
This study is to see if venetoclax in combination with bendamustine and rituximab chemotherapy is effective in treating people who have mantle cell lymphoma and to examine the side effects, good and bad, associated with this combination .
Must have measurable or evaluable disease as defined as a lymph node measuring >1.5 cm in any dimension or splenomegaly with spleen >15 cm in craniocaudal dimension
ECOG performance status of 0-2
Adequate organ function as measured by the criteria
Total Bilirubin ≤ 1.5x upper limit of normal (ULN) or ≤ 3x ULN with documented Gilbert’s syndrome
Should not have prior chemotherapy, radiotherapy or immunotherapy for lymphoma
Must not have received a prior allogeneic stem cell transplant or solid organ transplant (except for cornea) for any indication
Must have no active, uncontrolled infections
Must not have active hepatitis B or be chronic carriers of hepatitis B.
A Randomized, Double-Blind, Phase III Trial of Paclitaxel/Trastuzumab/Pertuzumab with Atezolizumab or Placebo in First-Line HER2-Positive Metastatic Breast Cancer (NRG-BR004) (PSCI# 20-136)
The purpose of this study is to compare the usual treatment plus placebo to the usual treatment plus atezolizumab. The addition of atezolizumab to the usual treatment could stabilize your cancer. 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 atezolizumab lengthens the time during and after the treatment of your cancer that you live with your cancer and it is stable. Atezolizumab is already approved by the FDA for use in non-small cell lung cancer and urinary cancer. Its use in this study is considered experimental. There will be about 600 people taking part in this study.
pt will initially get the chemotherapy drug paclitaxel or docetaxel along with trastuzumab, pertuzumab, and either placebo or atezolizumab.
Histologically confirmed adenocarcinoma of the breast with locally recurrent, unresectable disease, or metastatic disease
Adequate hematologic function within 14 days prior to randomization
Localized palliative radiation therapy is allowed for symptom management if completed 14 days or more prior to randomization
Adequate renal function determined within 14 days prior to randomization
History of exposure to cumulative doses of doxorubicin greater than 360 mg per square meter of body surface area or its equivalent
Prior treatment with mTOR inhibitors or CDK 4/6 inhibitors in combination with endocrine therapy for treatment of metastatic disease
History of asymptomatic LVEF decline to < 40% during or after prior HER2-targeted therapy
Prior treatment with CD137 agonists or immune checkpoint-blockade therapies, including antiCD40, anti-CTLA-4, anti-PD-1, and anti-PD-L1 therapeutic antibodies
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.
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.
18 or older
Adequate hematologic function
Adequate hepatic function
Adequate renal function
Prior radiotherapy
Prior immunotherapy
Major surgery within 28 days prior to Step 1 registration
Uncontrolled hypertension
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
Phase III Trial of Concurrent Chemoradiotherapy with or without Atezolizumab (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.
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
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.
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.
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
KEYSTROKE: A RANDOMIZED PHASE II STUDY OF PEMBROLIZUMAB (KEYTRUDA®) PLUS STEREOTACTIC RE-IRRADIATION VERSUS SBRT ALONE FOR LOCOREGIONALLY RECURRENT OR SECOND PRIMARY HEAD AND NECK CARCINOMA
Study of Pembrolizumab (KEYTRUDA®) Plus non-surgical radiation therapy Versus non-surgical radiation therapy alone for Recurrent or Second Primary Head and Neck Cancer. This study is evaluating the safety of the addition of pembrolizumab to non-surgical radiation therapy.
The purpose of this voluntary research study is to compare any good and bad effects of using the study drug, pembrolizumab, plus radiation therapy to using radiation therapy alone. The addition of the study drug to radiation could shrink your cancer/prevent it from returning but it could also cause side effects.
Patients for whom resection would be medically contraindicated and/or would impose excessive surgical risk
Patients must have had prior radiation to the head and neck
Tumors that involve more than 180 degrees of the carotid artery
Patients with tumor ulceration through the skin
Disease that requires two or more discontiguous target volumes will be ineligible.
Phase II Trial of Palbociclib with Fulvestrant in Individuals withHormone 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.
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.
Phase II Trial of Eflornithine (DFMO) and Etoposide for Relapsed/Refractory Neuroblastoma
This is a study of the drug DFMO (difluoromethylornithine) for neuroblastoma that has returned or not responded to treatment. DFMO is an oral drug that inhibits a certain enzyme (protein) in blood which is associated with a bad outcome in neuroblastoma cases. Cancer cells have pathways that drive the cancer to grow and DFMO targets the specific pathway of this enzyme to turn these cells off.
You will have exams, tests, and procedures while on the study to evaluate whether you can participate in the study and how you are doing while on the study. These include physical exams, blood tests, urine tests, bone marrow aspirate and biopsies, heart tests, hearing tests, and imaging evaluations such as CT scans and MIBG or PET scans. You will receive treatment on this study for a total of about 2 years. After treatment, you will have follow-up examinations and medical tests. We would like to continue to find out about your health for about 5 years after you complete the study.
Completed upfront therapy with at least 4 cycles of aggressive multi-drug chemotherapy
Currently receiving another investigational drug
Parallel Phase III Randomized Trials For High Risk Prostate Cancer Evaluating De-Intensification For Lower Genomic Risk and Intensification for Higher Genomic Risk with Radiation (NRG-GU009) (PSCI# 20-141)
This study is being done to answer the following questions: If you have high risk prostate cancer, a low gene risk score and plan to receive radiation therapy, is a shorter hormone therapy treatment as effective at controlling your cancer compared to the usual 24 month hormone therapy treatment? If you have high risk prostate cancer, a high gene risk score and plan to receive radiation therapy, does adding two new hormone therapy drugs to the usual treatment increase the length of time without your prostate cancer spreading as compared to the usual treatment?We are doing this study because we want to find out if these approaches are better, similar, or worse than the usual approach for your type of prostate cancer. The usual treatment is defined as the care most people get for prostate cancer.
This study is being done to answer the following questions:If you have high risk prostate cancer, a low gene risk score and plan to receive radiation therapy, is a shorter hormone therapy treatment as effective at controlling your cancer compared to the usual 24 month hormone therapy treatment?If you have high risk prostate cancer, a high gene risk score and plan to receive radiation therapy, does adding two new hormone therapy drugs to the usual treatment increase the length of time without your prostate cancer spreading as compared to the usual treatment?We are doing this study because we want to find out if these approaches are better, similar, or worse than the usual approach for your type of prostate cancer. The usual treatment is defined as the care most people get for prostate cance
High-risk disease
ECOG Performance Status of 0-2 within 120 days prior to registration
Adequate hematologic function within 120 days prior to registration
Adequate hepatic function within 120 days prior to registration
Prior systemic chemotherapy within ≤3 years prior to registration
Current use of 5-alpha reductase inhibitor
Didanosine (DDI) antiretroviral therapy is not permitted
History of seizure disorder or current severe or unstable angina
An Open-Label, Randomized, Controlled Multi-Center Study of The Efficacy of Daromun (L19IL2 + L19TNF) Neoadjuvant Intratumoral Treatment Followed by Surgery and Adjuvant Therapy Versus Surgery and Adjuvant Therapy in Clinical Stage IIIB/C Melanoma Patients
The purpose of this study is to test the efficacy of Daromun neoadjuvant treatment followed by surgery and adjuvant therapy to improve in a statistically significant manner the recurrence-free survival (RFS) of Stage IIIB/C melanoma patients with respect to the standard of care (surgery and adjuvant therapy)
•Blood collection for laboratory tests•CT/MRI/PET/CT scans•ECG•Take study drug•Tumor assessment
Eligible subjects must have measurable disease and must be candidate for intralesional therapy with at least one injectable cutaneous, subcutaneous, or nodal melanoma lesion
Males or females, age ≥ 18 years
ECOG Performance Status/WHO Performance Status ≤ 1.
Life expectancy of > 24 months
Evidence of distant metastases at screening
Previous or concurrent cancer that is distinct in primary site or histology from the cancer being evaluated in this study except cervical carcinoma in situ
Presence of active infections
History within the last year of acute or subacute coronary syndromes including myocardial infarction, unstable or severe stable angina pectoris
Telehealth Navigation for Informed Prostate Cancer Screening in Black Men
This study is being conducted to determine whether patient navigation improves informed decision making for prostate cancer screening. Participants will be offered the opportunity to discuss and address issues related to PSA testing with a patient navigator over a one month period. Surveys at the beginning and end of this period will include health knowledge, opinions on telehealth, and barriers to health care. All sessions will be conducted virtually.
Complete short on-line questionnairesComplete at least one telehealth session with the Patient Navigator
100
ages 45 to 70
spoken english language
PSCI# 18-049 A PHASE II, DOUBLE-BLINDED, PLACEBO-CONTROLLED RANDOMIZED TRIAL OF SALVAGE RADIOTHERAPY WITH OR WITHOUT ENHANCED ANTI-ANDROGEN THERAPY WITH APALUTAMIDE IN RECURRENT PROSTATE CANCER
To determine whether, in men with post-prostatectomy PSA recurrences, salvage radiation (SRT) with enhanced anti-androgen therapy with apalutamide will improve biochemical progression-free survival (bPFS) compared to SRT alone.
To determine whether, in men with post-prostatectomy PSA recurrences, salvage radiation (SRT) with enhanced anti-androgen therapy with apalutamide will improve biochemical progression-free survival (bPFS) compared to SRT alone.
Post-prostatectomy patients with a detectable serum PSA (≥0.1, but ≤1.0 ng/mL) at study entry (within 90 days of Step 1 registration) a
pN0 or pNx
History/physical examination within 90 days prior to Step 1 registration
Karnofsky performance status of 70-100 within 90 days prior to Step 1 registration
Prior invasive malignancy (except non-melanomatous skin cancer, carcinoma in situ of the male breast, penis, oral cavity, or stage Ta of the bladder, or stage I completely resected melanoma) unless disease free for a minimum of 2 years
Prior systemic chemotherapy for the study cancer
Prior radiotherapy to the region of the study cancer that would result in overlap of radiation therapy fields;
Prior whole gland ablative therapy
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