95 results for "Therapy "

RTOG-0924: Prostate Cancer and the Effects of Androgen-Deprivation Therapy and Radiation Therapy

Androgens can cause the growth of prostate cancer cells. Androgen deprivation therapy may stop the adrenal glands from making androgens. Radiation therapy uses high-energy X-Rays to kill tumor cells. This randomized phase III trial studies androgen-deprivation therapy and radiation therapy in treating patients with prostate cancer.

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EAY131: Molecular Analysis for Therapy Choice (MATCH)

This phase II trial studies how well treatment that is directed by genetic testing works in patients with solid tumors or lymphomas that have progressed following at least one line of standard treatment or for which no agreed upon treatment approach exists. Genetic tests look at the unique genetic material (genes) of patients' tumor cells. Patients with genetic abnormalities (such as mutations, amplifications, or translocations) may benefit more from treatment which targets their tumor's particular genetic abnormality. Identifying these genetic abnormalities first may help doctors plan better treatment for patients with solid tumors, lymphomas, or multiple myeloma.

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Barostim Therapy for Heart Failure (BeAT-HF)

The objective of this study is to demonstrate that treatment with the Barostim neo system, relative to medical management, reduces the rate of cardiovascular mortality or worsening heart failure that leads to hospitalization, cardiac assist device or heart transplant.

CA209-901: Nivolumab + Ipilimumab or SOC Chemotherapy VS SOC Chemotherapy Alone for Urothelial Cancer

The purpose of this study is to determine whether an investigational immunotherapy nivolumab in combination with ipilimumab or in combination with standard of care chemotherapy is more effective than standard of care chemotherapy alone in treating patients with previously untreated inoperable or metastatic urothelial cancer.

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NRG-GU002: Prostate Cancer and the Effects of Anti-Androgen Therapy and Radiation Therapy +/- Docetaxel

This randomized phase II / III trial studies docetaxel, antiandrogen therapy, and radiation therapy to see how well it works compared with antiandrogen therapy and radiation therapy alone in treating patients with prostate cancer that has been removed by surgery. Androgen can cause the growth of prostate cells. Antihormone therapy may lessen the amount of androgen made by the body. Radiation therapy uses high energy x-rays to kill tumor cells and shrink tumors. Drugs used in chemotherapy, such as docetaxel, work in different ways to stop the growth of tumor cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Giving antiandrogen therapy and radiation therapy with or without docetaxel after surgery may kill any remaining tumor cells.

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MIT-201701: Observational Study Examining Empirically Selected Therapy vs. CANscript Recommended Therapy (CANscript)

The purpose of this study is to test the CANscript™ sensitivity assay, which is a new and different assay developed to test the sensitivity of different cancer types to physician selected therapies (both drugs and/or drug combinations) indicated for the stage and type of cancer for treatment. CANscript™ tests how a patients specific tumor reacts to the therapies being considered by the treating physician. CANscript™ test results have been shown to closely correspond with actual clinical results, providing physicians with information that may help him/her develop a more personalized cancer treatment and care plan based on the patients specific condition. The researchers want to see if CANscript™ test results are helpful in selecting the treatments prescribed and provided. There will be about 800 people taking part in this study, across 5 different tumor types. The study is designed to assess the decision impact of the CANscript™ test results in informing physicians in therapy selection.

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EA1131: Breast Cancer and the Effects of Platinum Based Chemotherapy

This randomized phase III trial studies how well cisplatin or carboplatin (platinum based chemotherapy) works compared to observation in treating patients with remaining (residual) basal-like triple-negative breast cancer following chemotherapy after surgery (neoadjuvant). Drugs used in chemotherapy, such as cisplatin and carboplatin, work in different ways to stop the growth of tumor cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. It is not yet known whether cisplatin or carboplatin is more effective than observation in treating patients with residual triple negative basal-like breast cancer.

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RTOG-1008: RT +/- Chemotherapy for High-Risk Malignant Salivary Gland Tumors that have been Surgically Removed

This randomized phase II/III trial is studying radiation therapy with or without chemotherapy to see how well it works in treating patients with high-risk malignant salivary gland tumors that have been removed by surgery.

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Astellas EV-301: Enfortumab vs Chemotherapy for Metastatic Urothelial Cancer

The purpose of this study is to compare the overall survival (OS) of participants with locally advanced or metastatic urothelial cancer treated with enfortumab vedotin (EV) to the OS of participants treated with chemotherapy.

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Observational Study to evaluate patients receiving Transarterial Chemoembolization (TACE) Therapy

The purpose of this study is to determine if there is a link between liver cancer recurrences after liver transplant, in a specific population of patients who have received TACE therapy.

A091605: Pembrolizumab +/- Stereotactic Body Radiation Therapy for Advanced Merkel Cell Cancer

This randomized phase II trial studies how well Pembrolizumab with or without stereotactic body radiation therapy works in treating patients with Merkel Cell Cancer that has spread to other places in the body. Monoclonal antibodies, such as Pembrolizumab, may interfere with the ability of tumor cells to grow and spread. Stereotactic body radiation therapy is a specialized radiation therapy that sends X-Rays directly to the tumor using smaller doses over several days and may cause less damage to normal tissue. Giving Pembrolizumab with stereotactic body radiation therapy may work better in treating patients with Merkel Cell Cancer.

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ACNS0831: Ependymoma and Effects of Maintenance Chemotherapy vs. Observation After Induction Chemoradiation


This randomized phase III trial is studying maintenance chemotherapy to see how well it works compared to observation following induction chemotherapy and radiation therapy in treating young patients with newly diagnosed ependymoma. Drugs used in chemotherapy, such as vincristine sulfate, carboplatin, cyclophosphamide, etoposide, and cisplatin, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Giving more than one drug (combination chemotherapy) may kill more tumor cells. Radiation therapy uses high-energy x-rays to kill tumor cells. Specialized radiation therapy that delivers a high dose of radiation directly to the tumor may kill more tumor cells and cause less damage to normal tissue. Giving chemotherapy with radiation therapy may kill more tumor cells and allow doctors to save the part of the body where the cancer started.

ACNS1422: Reduced Craniospinal RT and Chemotherapy for Newly Diagnosed WNT-Driven Medulloblastoma

This phase II trial studies how well reduced doses of radiation therapy to the brain and spine (craniospinal) and chemotherapy work in treating patients with newly diagnosed type of brain tumor called WNT)/Wingless (WNT)-driven medulloblastoma. Recent studies using chemotherapy and radiation therapy have been shown to be effective in treating patients with WNT-driven medulloblastoma. However, there is a concern about the late side effects of treatment, such as learning difficulties, lower amounts of hormones, or other problems in performing daily activities. Radiotherapy uses high-energy radiation from x-rays to kill cancer cells and shrink tumors. Drugs used in chemotherapy, such as cisplatin, vincristine sulfate, cyclophosphamide and lomustine, work in different ways to stop the growth of tumor cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Giving reduced craniospinal radiation therapy and chemotherapy may kill tumor cells and may also reduce the late side effects of treatment.

NRG-GI002: Rectal Cancer and the Effects of Veliparib and Combination Chemotherapy

This randomized phase II trial studies how well veliparib works with combination chemotherapy and radiation therapy in treating patients with rectal cancer that has spread from where it started to nearby tissue or lymph nodes (locally advanced). Veliparib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Drugs used in chemotherapy, such as modified (m)FOLFOX6 regimen, work in different ways to stop the growth of tumor cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Radiation therapy uses high-energy x-rays to kill tumor cells and shrink tumors. Giving veliparib with combination chemotherapy and radiation therapy may kill more tumor cells and giving it before surgery may make the tumor smaller and reduce the amount of normal tissue that needs to be removed.

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ARST1431: Combination Chemotherapy with or without Temsirolimus for Intermediate-Risk Rhabdomyosarcoma

This randomized phase III trial studies how well combination chemotherapy (vincristine sulfate, dactinomycin, cyclophosphamide alternated with vincristine sulfate and irinotecan hydrochloride) works compared to combination chemotherapy plus temsirolimus in treating patients with rhabdomyosarcoma (cancer that forms in the soft tissues, such as muscle), and has an intermediate chance of coming back after treatment (intermediate risk). Drugs used in chemotherapy work in different ways to stop the growth of tumor cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Combination chemotherapy and temsirolimus may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. It is not yet known whether combination chemotherapy or combination chemotherapy plus temsirolimus is more effective in treating patients with intermediate-risk rhabdomyosarcoma.

AFT-38: Clinical Study of the Targeted Therapy, Palbociclib, to Treat Metastatic Breast Cancer (PATINA)

The primary objective of this study is to demonstrate that the combination of palbociclib with anti-HER2 therapy plus endocrine therapy is superior to anti-HER2-based therapy plus endocrine therapy alone in improving the outcomes of subjects with hormone receptor-positive, HER2+ metastatic breast cancer.

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AALL1631: Imatinib Mesylate and Combination Chemotherapy in Newly Diagnosed Philadelphia Chromosome + ALL

This randomized phase III trial studies how well imatinib mesylate and combination chemotherapy work in treating patients with newly diagnosed Philadelphia chromosome positive acute lymphoblastic leukemia. Imatinib mesylate may stop the growth of cancer cells by blocking some of the enzymes needed for cell growth. Drugs used in chemotherapy, work in different ways to stop the growth of cancer cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Giving imatinib mesylate and combination chemotherapy may work better in treating patients with Philadelphia chromosome positive acute lymphoblastic leukemia.

APEC1621: Advanced Solid Tumors, Non-Hodgkin Lymphomas, or Histiocytic Disorders and Targeted Therapy

This screening and multi-sub-study phase II trial studies how well treatment that is directed by genetic testing works in pediatric patients with solid tumors, non-Hodgkin lymphomas, or histiocytic disorders that have progressed following at least one line of standard systemic therapy and/or for which no standard treatment exists that has been shown to prolong survival. Genetic tests look at the unique genetic material (genes) of patients' tumor cells. Patients with genetic changes or abnormalities (mutations) may benefit more from treatment which targets their tumor's particular genetic mutation, and may help doctors plan better treatment for patients with solid tumors or non-Hodgkin lymphomas.

NRG-GI004: Combination Chemotherapy, Bevacizumab, and/or Atezolizumab for dMMR Metastatic Colorectal Cancer

This randomized phase III trial studies how well combination chemotherapy, bevacizumab, and/or atezolizumab work in treating patients with deficient DNA mismatch repair colorectal cancer that has spread to other places in the body. Drugs used in chemotherapy, such as fluorouracil, oxaliplatin, and leucovorin calcium, work in different ways to stop the growth of tumor cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Monoclonal antibodies, such as bevacizumab and atezolizumab, may interfere with the ability of tumor cells to grow and spread. Giving combination chemotherapy, bevacizumab, and atezolizumab may work better in treating patients with colorectal cancer.

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ALTE16C1: Biospecimen Analysis in Determining Effects of Chemotherapy on Fertility in Osteosarcoma Survivors

This research trial studies saliva, semen, and blood samples to determine effects of chemotherapy on fertility in osteosarcoma survivors. Study biospecimen samples from osteosarcoma survivors in the laboratory may help doctors learn whether chemotherapy causes fertility problems and to learn more about the long term effects.

ANHL12P1: Brentuximab Vedotin or Crizotinib and Chemotherapy in Treating Anaplastic Large Cell Lymphoma

This partially randomized phase II trial studies how well brentuximab vedotin or crizotinib and combination chemotherapy works in treating patients with newly diagnosed stage II-IV anaplastic large cell lymphoma. Monoclonal antibody-drug conjugates, such as brentuximab vedotin, can block cancer growth in different ways by targeting certain cells. Crizotinib and methotrexate may stop the growth of cancer cells by blocking some of the enzymes needed for cell growth. Drugs used in chemotherapy work in different ways to stop the growth of cancer cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. It is not yet known whether brentuximab vedotin and combination chemotherapy is more effective than crizotinib and combination chemotherapy in treating anaplastic large cell lymphoma.

GOG-0279: Cisplatin + Gemcitabine & Radiation Therapy for Squamous Cell Carcinoma of the Vulva

This phase II trial studies how well radiation therapy works when given with gemcitabine hydrochloride and cisplatin work in treating patients with squamous cell cancer of the vulva that has spread from where it started to nearby tissue or lymph nodes. Specialized radiation therapy that delivers a high dose of radiation directly to the tumor may kill more tumor cells and cause less damage to normal tissue. Drugs used in chemotherapy, such as gemcitabine hydrochloride and cisplatin, work in different ways to stop the growth of tumor cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Giving radiation therapy together with gemcitabine hydrochloride and cisplatin may kill more tumor cells.

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CALGB-30610: Radiation Therapy Regimens for Limited-Stage Small Cell Lung Cancer Receiving Cisplatin and Etoposide

Radiation therapy uses high-energy x-rays to kill tumor cells. Drugs used in chemotherapy, such as etoposide, carboplatin and cisplatin, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. It is not yet known which radiation therapy regimen is more effective when given together with chemotherapy in treating patients with limited-stage small cell lung cancer. This randomized phase III trial is comparing different chest radiation therapy regimens to see how well they work in treating patients with limited-stage small cell lung cancer.

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GRAHF-2 (Genomic Response Analysis of Heart Failure Therapy in African Americans)

The purpose of this study is to evaluate the response to therapy when a fixed dose combination of isosorbide dinitrate and hydralazine (FDC I/H) is enhanced in African Americans with heart failure and reduced ejection fraction (HFrEF) when compared to similar white cohorts.

FIRST: Platinum-Based Therapy + TSR-042 and Niraparib VS SOC Platinum-Based Therapy as First-Line Treatment of Stage III or IV Nonmucinous Epithelial Ovarian Cancer

This is a global, multicenter, randomized, double-blind, controlled Phase III study in patients with newly diagnosed, Stage III or IV nonmucinous epithelial ovarian, fallopian tube, or peritoneal cancer (collectively referred to as "ovarian cancer"). The currently recommended standard of care therapy for the first line treatment of Stage III or IV ovarian cancer is the combination of Paclitaxel and Carboplatin, with or without concurrent and maintenance Bevacizumab.

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S1418: Triple Negative Breast Cancer and the Effects of MK3475 (Pembrolizumab) as Adjuvant Therapy

This randomized phase III trial studies how well pembrolizumab works in treating triple negative breast cancer. Monoclonal antibodies, such as pembrolizumab, may interfere with the ability of tumor cells to grow and spread.

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ANBL1232: Response and Biology-Based Risk Factor-Guided Therapy in Treating Non-High-Risk Neuroblastoma

This phase III trial studies how well response and biology-based risk factor-guided therapy works in treating younger patients with non-high risk neuroblastoma. Sometimes a tumor may not need treatment until it progresses. In this case, observation may be sufficient. Measuring biomarkers in tumor cells may help plan when effective treatment is necessary and what the best treatment is. Response and biology-based risk factor-guided therapy may be effective in treating patients with non-high risk neuroblastoma and may help to avoid some of the risks and side effects related to standard treatment.

A041501: Inotuzumab Ozogamicin & Frontline Chemotherapy in Treating Young Adults with Newly Diagnosed B-Cell ALL

This partially randomized phase III trial studies the side effects of Inotuzumab Ozogamicin and how well it works when given with frontline chemotherapy in treating patients with newly diagnosed B Acute Lymphoblastic Leukemia. Monoclonal antibodies, such as Inotuzumab Ozogamicin, may block cancer growth in different ways by targeting certain cells. Drugs used in chemotherapy work in different ways to stop the growth of tumor cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Giving Inotuzumab Ozogamicin with chemotherapy may work better in treating young adults with B Acute Lymphoblastic Leukemia.

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AHOD1331: Brentuximab Vedotin and Chemotherapy in Treating Stage IIB or Stage IIIB-IVB Hodgkin Lymphoma

This randomized phase III trial studies brentuximab vedotin and combination chemotherapy to see how well they work compared to combination chemotherapy alone in treating children and young adults with stage IIB or stage IIIB-IVB Hodgkin lymphoma. Combinations of biological substances in brentuximab vedotin may be able to carry cancer-killing substances directly to Hodgkin lymphoma cells. Drugs used in chemotherapy, such as doxorubicin hydrochloride, bleomycin sulfate, vincristine sulfate, etoposide, prednisone, and cyclophosphamide, work in different ways to stop the growth of cancer cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. It is not yet known if combination chemotherapy is more effective with or without brentuximab vedotin in treating Hodgkin lymphoma.

AFT-25: Comparison of Operative to Monitoring and Endocrine Therapy (COMET) Trial For Low Risk DCIS

This study looks at the risks and benefits of active surveillance (AS) compared to guideline concordant care (GCC) in the setting of a pragmatic prospective randomized trial for low risk DCIS. Our overarching hypothesis is that management of low-risk Ductal Carcinoma in Situ (DCIS) using an AS approach does not yield inferior cancer or quality of life outcomes compared to GCC.

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A011502: Node Positive HER2 Negative Breast Cancer and the Effects of Placebo vs. Aspirin as Adjuvant Therapy

This randomized phase III trial studies how well aspirin works in preventing the cancer from coming back (recurrence) in patients with human epidermal growth factor receptor 2 (HER2) breast cancer after chemotherapy, surgery, and/or radiation therapy. Aspirin is a drug that reduces pain, fever, inflammation, and blood clotting. It is also being studied in cancer prevention. Giving aspirin may reduce the rate of cancer recurrence in patients with breast cancer.

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COLO-007: ABI-009 (Nab-rapamycin) + FOLFOX & Bevacizumab as First-line Therapy for Advanced or Metastatic CRC

A phase 1/2 multi-center investigation of ABI-009 (nab-rapamycin) in combination with mFOLFOX6 and Bevacizumab as first-line therapy in patients with advanced or metastatic colorectal cancer.

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NSABP B-59: Neoadjuvant Chemotherapy with Atezolizumab or Placebo for TNBC Followed After Surgery by Atezolizumab or Placebo

The main purpose of this study is to learn if the usual chemotherapy given before surgery (neoadjuvant therapy) for breast cancer plus the experimental drug, Atezolizumab, is better than the usual chemotherapy plus a placebo. The usual chemotherapy in this study is Paclitaxel (WP) and Carboplatin followed by Doxorubicin and Cyclophosphamide (AC) or Epirubicin and Cyclophosphamide (EC). Usually, after neoadjuvant therapy and surgery for Triple Negative Breast Cancer, no additional treatment is given unless the cancer returns. This study will also look at continuing treatment after surgery with Atezolizumab or the placebo. To be better, Atezolizumab given with the neoadjuvant therapy should be better at: 1) decreasing the amount of tumor in the breast than the placebo given with the usual chemotherapy and 2) decreasing the chance of the cancer from returning after surgery.

Another purpose of this study is to test the good and bad effects of Atezolizumab when added to the usual chemotherapy. Atezolizumab may keep your cancer from growing but it can also cause side effects.

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AALL1131: Chemotherapy in Treating Young Patients with High-Risk B ALL and Ph-like Sensitive Mutations

This randomized phase III trial studies how well combination chemotherapy works in treating young patients with newly diagnosed B acute lymphoblastic leukemia that is likely to come back or spread, and in patients with Philadelphia chromosome (Ph)-like tyrosine kinase inhibitor (TKI) sensitive mutations. Drugs used in chemotherapy work in different ways to stop the growth of cancer cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Giving more than one drug (combination chemotherapy) and giving the drugs in different doses and in different combinations may kill more cancer cells.

S1608: Follicular Lymphoma and effects of Obinutuzumab +/- PI3K-delta Inhibitor TGR-1202, Lenalidomide, or Combination Chemotherapy

This randomized phase II trial studies how well obinutuzumab with or without PI3K-delta inhibitor TGR-1202, lenalidomide, or combination chemotherapy work in treating patients with grade I-IIIa follicular lymphoma that has come back or does not respond to treatment. Monoclonal antibodies, such as obinutuzumab, may interfere with the ability of cancer cells to grow and spread. PI3K-delta inhibitor TGR-1202 may stop the growth of cancer cells by blocking some of the enzymes needed for cell growth. Biological therapies, such as lenalidomide, use substances made from living organisms that may stimulate or suppress the immune system in different ways and stop cancer cells from growing. Drugs used in chemotherapy, such as cyclophosphamide, doxorubicin hydrochloride, vincristine sulfate, and prednisone, work in different ways to stop the growth of cancer cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. It is not yet known whether giving obinutuzumab with or without PI3K-delta inhibitor TGR-1202, lenalidomide, or combination chemotherapy will work better in treating patients with grade I-IIIa follicular lymphoma.

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STU 022015-069: Stage 1 NSCLC and the Effects of Sublobar Resection (SR) Versus Stereotactic Ablative Radiotherapy (STABLE-MATES Trial)

To Determine if Stereotactic Ablative Radiotherapy improves survival over Sublobar Resection in High Risk Operable Stage I NSCLC.

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Lung-MAP: Biomarker-Targeted Second-Line Therapy in Treating Patients with Recurrent Stage IV Squamous Cell Lung Cancer

This screening and multi-sub-study randomized phase II/III trial will establish a method for genomic screening of similar large cancer populations followed by assigning and accruing simultaneously to a multi-sub-study hybrid "Master Protocol" (S1400). The type of cancer trait (biomarker) will determine to which sub-study, within this protocol, a participant will be assigned to compare new targeted cancer therapy, designed to block the growth and spread of cancer, or combinations to standard of care therapy with the ultimate goal of being able to approve new targeted therapies in this setting. In addition, the protocol includes a "non-match" sub-study which will include all screened patients not eligible for any of the biomarker-driven sub-studies. This sub-study will compare a non-match therapy to standard of care also with the goal of approval.

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RTOG-1112: Hepatocellular Carcinoma and the Effects of Sorafenib vs SBRT + Sorafenib

This randomized phase III trial studies sorafenib tosylate and stereotactic body radiation therapy to see how well they work compared to sorafenib tosylate alone in treating patients with liver cancer. Sorafenib tosylate may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Stereotactic body radiation therapy may be able to send the radiation dose directly to the tumor and cause less damage to normal tissue. Giving sorafenib tosylate together with stereotactic body radiation therapy may kill more tumor cells.

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NSABP B-51: Early Stage Breast Cancer and the Effects of Standard vs. Comprehensive Radiation

This randomized phase III trial studies standard or comprehensive radiation therapy in treating patients with early-stage breast cancer who have undergone surgery. Radiation therapy uses high-energy x rays to kill tumor cells. It is not yet known whether comprehensive radiation therapy is more effective than standard radiation therapy in treating patients with breast cancer.

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A011202: Node Positive Breast Cancer and the effects of Axillary Lymph Node Dissection Vs. Axillary Radiation

This randomized phase III trial studies axillary lymph node dissection to see how well it works compared to axillary radiation therapy in treating patients with node-positive breast cancer treated with neoadjuvant chemotherapy followed by surgery. Lymph node dissection may remove cancer cells that have spread to nearby lymph nodes in patients with breast cancer. Radiation therapy uses high-energy x-rays to kill tumor cells. This study will evaluate whether radiation therapy is as effective as lymph node dissection.

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AAML1531: AML in Down Syndrome and the Effects of Cytaribine, Daunorubicin Hydrochloride, Thioguanine

This phase III trial studies response-based chemotherapy in treating newly diagnosed acute myeloid leukemia or myelodysplastic syndrome in younger patients with Down syndrome. Drugs used in chemotherapy work in different ways to stop the growth of cancer cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Response-based chemotherapy separates patients into different risk groups and treats them according to how they respond to the first course of treatment (Induction I). Response-based treatment may be effective in treating acute myeloid leukemia or myelodysplastic syndrome in younger patients with Down syndrome while reducing the side effects.

M16-298: Small Cell Lung Cancer (SCLC) and the Effects of Rovalpituzumab Tesirine / Dexamethasone (MERU)

This is a Phase 3, randomized, double-blind, placebo-controlled, multinational, and multicenter study to evaluate the efficacy of rovalpituzumab tesirine as maintenance therapy following first-line platinum-based chemotherapy.

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EA5142: Non-Small Cell Lung Cancers and the Effects of Nivolumab (ANVIL)

This randomized phase III trial studies how well nivolumab after surgery and chemotherapy work in treating patients with stage IB-IIIA non-small cell lung cancer. Monoclonal antibodies, such as nivolumab, may stimulate the immune system in different ways and kill tumor cells remaining after surgery and standard of care chemotherapy.

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WF 97116: Phase 3 Randomized Placebo Controlled Clinical Trial of Donepezil

This study is to compare the safety and effects of Donepezil (Aricept) or if it decreases memory loss after receiving chemotherapy for breast cancer. A randomized, placebo controlled, double-blind, parallel group Phase 3 design will be used to assess the effect of 24 Weeks of Donepezil on cognitive function (memory) in breast cancer survivors who report having cognitive dysfunction and demonstrate memory impairment 1-5 Year post chemotherapy. Patients who meet the eligibility criteria will be stratified by age (<50, 50-59, 60-69, ≥70) and randomized to Donepezil or placebo with equal probability.

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HIMALAYA: Durvalumab + Tremelimumab as 1st-line Treatment for Unresectable Hepatocellular Carcinoma

This is a randomized, open-label, multi-center, global, Phase III study to assess the efficacy and safety of Durvalumab plus Tremelimumab combination therapy and Durvalumab monotherapy versus Sorafenib in the treatment of patients with no prior systemic therapy for unresectable HCC. The patients cannot be eligible for locoregional therapy.

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ALTE11C2: Effects of Dexrazoxane on Biomarkers Associated with Cardiomyopathy After Cancer Treatment (HEART)

This clinical trial studies the effects of dexrazoxane hydrochloride on biomarkers associated with cardiomyopathy and heart failure after cancer treatment. Studying samples of blood in the laboratory from patients receiving dexrazoxane hydrochloride may help doctors learn more about the effects of dexrazoxane hydrochloride on cells. It may also help doctors understand how well patients respond to treatment.

PREVENT II

PREVENT II is a prospective study of subjects receiving the HM II LVAD as per the current FDA approved indications for use that will investigate if subjects in the Treatment Arm (Warfarin + placebo) experience a reduced incidence of non-surgical bleeding without an increased risk of thromboembolic events.

NRG-GY006: Vaginal Cancer and/or Cervical Cancer and the Effects of Radiation and Cisplatin +/- IV Triapine

This randomized phase II trial studies radiation therapy and cisplatin with triapine to see how well they work compared to the standard radiation therapy and cisplatin alone in treating patients with newly diagnosed stage IB2, II, or IIIB-IVA cervical cancer or stage II-IVA vaginal cancer.

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NRG-GY005: Ovarian, Fallopian Tube, or Peritoneal Cancer and the Effects of Cediranib + / - Olaparib

This randomized phase II/III trial studies how well cediranib maleate and olaparib work when given together or separately, and compares them to standard chemotherapy in treating patients with ovarian, fallopian tube, or primary peritoneal cancer that has returned after receiving chemotherapy with drugs that contain platinum (platinum-resistant) or continued to grow while being treated with platinum-based chemotherapy drugs (platinum-refractory). Cediranib maleate and olaparib may stop the growth of tumor cells by blocking enzymes needed for cell growth. Drugs used in chemotherapy work in different ways to stop the growth of tumor cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. It is not yet known whether giving cediranib maleate and olaparib together may cause more damage to cancer cells when compared to either drug alone or standard chemotherapy.

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E1910: BCR-ABL Negative B Lineage ALL and the Effects of Blinatumomab

This randomized phase III trial studies combination chemotherapy with blinatumomab to see how well it works compared to induction chemotherapy alone in treating patients with newly diagnosed breakpoint cluster region (BCR)-c-abl oncogene 1, non-receptor tyrosine kinase (ABL)-negative B lineage acute lymphoblastic leukemia. Drugs used in chemotherapy work in different ways to stop the growth of cancer cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Monoclonal antibodies, such as blinatumomab, may block cancer growth in different ways by targeting certain cells. It is not yet known whether combination chemotherapy is more effective with or without blinatumomab in treating newly diagnosed acute lymphoblastic leukemia.

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A221505: Hypofractionated RT After Mastectomy in Preventing Recurrence in Stage IIa-IIIa Breast Cancer

This randomized phase III trial studies how well hypofractionated radiation therapy works in preventing recurrence in patients with Stage IIa-IIIa Breast Cancer who have undergone mastectomy. Hypofractionated radiation therapy delivers higher doses of radiation therapy over a shorter period of time and may kill more tumor cells that remain after surgery and have fewer side effects.

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ACCL1333/CV185-155: ALL or Lymphoma (T or B Cell) and the Effects of Apixaban for Thromboembolism Prevention

To compare the effect of prophylactic oral or enteric apixaban versus no administration of systemic prophylactic anticoagulant during induction chemotherapy, on the composite endpoint of adjudicated non-fatal deep vein thrombosis (DVT, including asymptomatic and symptomatic), pulmonary embolism (PE), and cerebral venous sinus thrombosis (CSVT); and venous thrombosis (VTE) -related-death during 25-28 days of open-label treatment in pediatric subjects (1 to < 18 years) with newly diagnosed ALL or lymphoma (T or B cell), a functioning Central Venous Access Device(CVAD) and receiving pegylated L-asparaginase during chemotherapy induction and to assess the effect of prophylactic oral or enteric apixaban versus no administration of systemic prophylactic anticoagulant during induction chemotherapy, on adjudicated major bleeding events during 25-28 days of open-label treatment.

NRG-GY007: Ruxolitinib, Paclitaxel, & Carboplatin for Stage III-IV Epithelial Ovarian Cancer

This phase I/II partially randomized trial studies the side effects and the best dose of Ruxolitinib Phosphate when given together with Paclitaxel and Carboplatin and to see how well they work in treating patients with Stage III-IV Epithelial Ovarian, Fallopian Tube, or Primary Peritoneal Cancer. Ruxolitinib Phosphate may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Drugs used in chemotherapy, such as Paclitaxel and Carboplatin, work in different ways to stop the growth of tumor cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Giving Ruxolitinib Phosphate together with Paclitaxel and Carboplatin may be a better treatment for Epithelial Ovarian, Fallopian Tube, or Primary Peritoneal Cancer.

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AREN1721: Axitinib and Nivolumab in Treating Unresectable or Metastatic TFE/Translocation Renal Cell Carcinoma

This phase II trial studies how well axitinib and nivolumab works in treating participants with TFE/translocation renal cell carcinoma that cannot be removed by surgery or has spread to other places in the body. Axitinib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Immunotherapy with monoclonal antibodies, such as nivolumab, may help the body's immune system attack the cancer, and may interfere with the ability of tumor cells to grow and spread. Giving axitinib and nivolumab may work better in treating participants with TFE/translocation renal cell carcinoma.

OPUS Registry

Opsumit is a newly available endothelin receptor antagonist (ERA) in the US. Evaluating the safety profile of Opsumit in the post-marketing setting will provide further characterization of its use from clinical practice. This study is a prospective observational drug registry developed to characterize the safety profile (including primarily potential serious hepatic risks) and to describe clinical characteristics and outcomes of patients newly treated with Opsumit in the post-marketing setting.

NCT02126943

NRG-BR003: Breast Cancer and the Effects of Doxorubicin + Cyclophosphamide, then Paclitaxel +/- Carboplatin

This randomized phase III trial studies how well doxorubicin hydrochloride and cyclophosphamide followed by paclitaxel with or without carboplatin work in treating patients with triple-negative breast cancer. Drugs used in chemotherapy, such as doxorubicin hydrochloride, cyclophosphamide, paclitaxel, and carboplatin, work in different ways to stop the growth of tumor cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. It is not yet known whether doxorubicin hydrochloride and cyclophosphamide is more effective when followed by paclitaxel alone or paclitaxel and carboplatin in treating triple-negative breast cancer.

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AG013-ODOM-201: Oral Mucositis in Head & Neck Cancer Patients and the Effects of Topically-applied AG013

The purpose of the study is to evaluate, safety and tolerability administered AG013 compared to placebo for reducing Oral Mucositis in patients undergoing chemoradiation for the treatment of head and neck cancer, as measured by the duration, time and development, and overall incidence of Om during the active treatment phase, beginning from the start of radiation therapy until 2 weeks following its completion.

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Endometriosis-Associated Pain and the effects of Elagolix with Estradiol/Norethindron Acetate

This study evaluates the safety and efficacy of Elagolix in combination with concomitant hormonal add-back therapy (E2/NETA) in the management of endometriosis-associated pain (EAP) in premenopausal women.

Rucaparib vs. Physician's Choice in Metastatic CRPC & Homologous Recombination Gene Deficiency

The purpose of this study is to determine how patients with metastatic castration-resistant prostate cancer, and evidence of a homologous recombination gene deficiency, respond to treatment with rucaparib versus treatment with physician's choice of abiraterone acetate, enzalutamide, or docetaxel.

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ATHENA: Rucaparib & Nivolumab as Maintenance following response to 1st-Line Platinum Chemo for Ovarian Cancer

This is a Phase 3, randomized, multinational, double-blind, dual placebo-controlled, 4-arm study evaluating rucaparib and nivolumab as maintenance treatment following response to front-line treatment in newly diagnosed ovarian cancer patients. Response to treatment will be analyzed based on homologous recombination (HR) status of tumor samples.

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S1400F: Durvalumab and Tremelimumab in Treating Patients with Recurrent Stage IV Lung Cancer

This phase II trial studies how well Durvalumab and Tremelimumab works in treating patients with Stage IV Lung Cancer that has come back after previous treatment. Monoclonal antibodies, such as Durvalumab and Tremelimumab, may interfere with the ability of tumor cells to grow and spread.

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Premenopausal Women with Uterine Fibroids and the effects of Elagolix

This study evaluates the long-term efficacy and safety of Elagolix administered alone and in combination with add-back therapy (estradiol/norethindrone acetate or E2/NETA) to reduce heavy menstrual bleeding (HMB) associated with uterine fibroids.

FEN-T14: Intravenous Fenretinide Emulsion for Relapsed/Refractory Peripheral T-Cell Lymphomas

This is an open-label, multicenter, single arm efficacy and safety study in patients with relapsed or refractory peripheral T-cell lymphoma, who have failed at least one prior system therapy.

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AALL1331: Pediatric B-Cell Acute Lymphoblastic Leukemia and the Effects of Blinatumomab

This randomized phase III trial compares how well blinatumomab works compared with standard combination chemotherapy in treating patients with B-cell acute lymphoblastic leukemia that has returned after a period of improvement (relapsed). Monoclonal antibodies, such as blinatumomab, can block cancer growth by finding cancer cells and helping to kill them or carrying cancer-killing substances to them. It is not yet known whether standard combination chemotherapy is more effective than blinatumomab in treating relapsed B-cell acute lymphoblastic leukemia.

ALTE1621: Carvedilol in Preventing Heart Failure in Childhood Cancer Survivors

This randomized phase IIb trial studies how well low-dose carvedilol works in preventing heart failure in cancer survivors exposed to high dose anthracyclines for management of childhood cancer. Patients who received high-dose anthracycline chemotherapy are at a much greater risk for developing heart failure compared to survivors who didn't get any anthracycline chemotherapy. Heart failure happens when the heart muscle has been weakened and can't pump blood as well as it should. Carvedilol may help lower the risk of cardiovascular complications.

AdaptResponse Clinical Trial

This study is testing the hypothesis that market released Cardiac Resynchronization Therapy (CRT) devices that contain the AdativCRT® (aCRT) algorithm have a superior outcome compared to standard CRT devices in CRT indicated patients with normal atrio-ventricular (AV) condition and left bundle branch block (LBBB).

VICCGI1523: Liver Cancer and the Effect of SIR-Spheres

This research trial studies Yttrium Y 90 resin microspheres in collecting data from patients with liver cancer not capable of being removed by surgery (unresectable) for the radiation-emitting Selective Internal Radiation-Spheres (SIR-spheres) in non-resectable (RESIN) liver tumor registry. The information generated will help doctors better understand treatment patterns involving Y90 therapy, gain additional insights in the long-term outcomes for patients, as well as guide future research for using Y90 therapy, especially for those conditions where data is currently very limited or lacking.

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GSK 201973: ER Positive Breast Cancer and the Effects of GSK525762 with Fulvestrant

This is a combination Phase I and II study, with an aim to evaluate the combination of GSK525762 and fulvestrant in women with advanced or metastatic ER+ breast cancer, who has disease that has progressed after prior treatment with at least one line of endocrine therapy.

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DORA Trial: A Study to Test Radium-223 with Docetaxel in Patients with Prostate Cancer

This is an open-labeled, randomized, phase III study of Docetaxel versus Docetaxel in combination with Radium-223 in subjects with mCRPC. The purpose of this study is to compare any good and bad effects of using Radium-223 along with Docetaxel chemotherapy treatment versus using Docetaxel alone.

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CODEX: Study of Inodiftagene Vixteplasmid (BC-819) in Unresponsive NMIBC

This study, BC-819-18-204, is a Phase II, open-label, monotherapy, single-arm, multicenter clinical trial of BC-819 (Inodiftagene Vixteplasmid) in patients with NMIBC adequately treated with Bacillus Calmette-Guerin (BCG) whose disease is BCG unresponsive according to the US Food and Drug Administration (FDA) guidance.

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DCL-16-001: Select B-Cell Malignancies and the Effects of CLR 131

This study evaluates CLR 131 in patients with select B Cell Malignancies, including Multiple Myeloma (MM), Indolent Chronic Lymphocytic Leukemia (CLL) / Small Lymphocytic Lymphoma (SLL), Lymphoplasmacytic Lymphoma (LPL), Marginal Zone Lymphoma (MZL), Mantle Cell Lymphoma (MCL), and Diffuse Large B Cell Lymphoma (DLBCL) who have been previously treated with standard therapy for their underlying malignancy.

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Respond CAS

The objective of the Continued Access study is to gather confirmatory evidence on the safety of the SonRtip lead and performance of the automatic atrioventricular (AV) delay and interventricular (VV) delay optimization algorithm used in the PARADYM RF SONR Cardiac Resynchronization Therapy with Defibrillation (CRT-D) device (Model 9770) in a patient population that is reflective of current heart failure treatment practice.

AAML1331: Acute Promyelocytic Leukemia and the Effects of Arsenic Trioxide and All-trans Retinoic Acid

This phase III trial studies tretinoin and arsenic trioxide in treating patients with newly diagnosed acute promyelocytic leukemia. Standard treatment for acute promyelocytic leukemia involves high doses of a common class of chemotherapy drugs called anthracyclines, which are known to cause long-term side effects, especially to the heart. Tretinoin may stop the growth of cancer cells by blocking some of the enzymes needed for cell growth. Arsenic trioxide may stop the growth of cancer cells by either killing the cells, by stopping them from dividing, or by stopping them from spreading. Completely removing or reducing the amount of anthracycline chemotherapy and giving tretinoin together with arsenic trioxide may be an effective treatment for acute promyelocytic leukemia and may reduce some of the long-term side effects.

USA-MCI GON-1.01: Ovarian Cancer and the Effects of Screening Using Gynecologic Fluids and Mucus

In this Phase II biomarker validation study we will further refine and validate these biomarkers using a new collection of samples from at least 200 ovarian cancer cases with epithelial ovarian cancer (endometroid and papillary serous histology, most common) and comparing these against 600 patients with a diagnosis of a benign adnexal mass that enter the clinics during the same time period. Patient samples will be collected on their first visit to the gynecologic oncologist at a number of collaborating clinics. Final processing of all of the samples will be performed within the proteomics research facilities of the Mitchell Cancer Institute using Selected Reaction Monitoring (SRM, with mass spectrometry) based on the refined set of makers statistically selected within the first aim. Biomarkers validated within this study will be compared with the well accepted CA-125 data for the patients. The research involves a three year validation and may allow detection of this cancer at a very early stage when the survival is as high as 90%. One aim examines a self-taken test that could allow its use in medically underrepresented and rural areas.

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S1501: Carvedilol in Preventing Cardiac Toxicity in Patients with Metastatic HER-2-Positive Breast Cancer

This phase III trial studies how well carvedilol works in preventing cardiac toxicity in patients with human epidermal growth factor receptor (HER)-2-positive breast cancer that has spread to other places in the body. A beta-blocker, such as carvedilol, is used to treat heart failure and high blood pressure, and it may prevent the heart from side effects of chemotherapy.

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S1619: Atezolizumab, Pemetrexed, Cisplatin, and Surgery +/- RT for Stage I-III Malignant Mesothelioma

This phase I pilot trial studies how well atezolizumab, pemetrexed disodium, cisplatin, and surgery with or without radiation therapy in treating patients with stage I-III pleural malignant mesothelioma. Monoclonal antibodies, such as atezolizumab, may interfere with the ability of tumor cells to grow and spread. Pemetrexed disodium may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Drugs used in chemotherapy, such as cisplatin, work in different ways to stop the growth of tumor cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Giving atezolizumab, pemetrexed disodium, and cisplatin before surgery may make the tumor smaller and reduce the amount of normal tissue that needs to be removed. Giving atezolizumab after surgery may kill any remaining tumor cells.

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PUMA-NER-5201: Patients with Malignant Solid Tumor Harboring Somatic ERBB and the Effects of Neratinib

This is an open-label, multicenter, multinational, Phase 2 study exploring the efficacy and safety of neratinib therapy in patients with solid tumors with activating ERBB (EGFR, ERBB2, ERBB3) mutations or with EGFR gene amplification. The trial will consist of a screening period, a treatment period, and an end of treatment visit occurring when neratinib is discontinued for any reason, a safety follow-up visit occurring 28 to 42 days after the last dose of neratinib and a survival follow-up period lasting for a maximum of 12 months for each patient after their last dose of neratinib or until initiation of additional anti -cancer therapy. Treatment will consist of neratinib alone 240 mg daily in all ERBB2 mutated cancers (solid tumors (NOS), ovarian, gastroesophageal, endometrial, and biliary tract) excluding hormone positive breast cancers.

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ALS and the effects of Phenylbutyrate (PB) and Tauroursodeoxycholic Acid (TUDCA)

AMX0035 is a combination therapy designed to reduce neuronal death through blockade of key cellular death pathways originating in the mitochondria and endoplasmic reticulum (ER). This clinical trial is designed to demonstrate that treatment is safe, tolerable, and able to slow decline in function as measured by the ALSFRS-R. The trial will also assess the effects of AMX0035 on muscle strength, vital capacity, and biomarkers of ALS including markers of neuronal death and neuroinflammation.

EAE161: CT Perfusion in Predicting Outcomes in Ovarian Cancer Receiving Bevacizumab

This phase II trial studies how well computed tomography perfusion imaging works in predicting outcomes in patients with ovarian, fallopian tube, or primary peritoneal cancer who are receiving bevacizumab. Computed tomography perfusion imaging monitors the effects of the drug treatment on the blood flow to the tumor and may help to predict whether a certain drug therapy is likely be successful in a patient with ovarian, fallopian tube, or primary peritoneal cancer.

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GlIadeL WAfer ImplaNT (VIGILANT) Registry

This is a prospective, observational registry in patients who have been prescribed Gliadel Wafer by the physician as part of usual care. Data will be collected on the safety and effectiveness of treatment with Gliadel Wafer perioperatively and ongoing during regular office visits up to 3-years. Patients enrolled in this registry will be asked to complete a questionnaire (Functional Assessment of Cancer Therapy-Brain [FACT-Br]) about their well-being and clinicians will complete the Karnofsky Performance Status (KPS) during office visits.

AGCT1531: Active Surveillance, Bleomycin, Carboplatin, Etoposide, or Cisplatin in Treating Germ Cell Tumors

This partially randomized phase III trial studies how well active surveillance, bleomycin, carboplatin, etoposide, or cisplatin work in treating pediatric and adult patients with germ cell tumors. Active surveillance may help doctors to monitor subjects with low risk germ cell tumors after their tumor is removed. Drugs used in chemotherapy, such as bleomycin, carboplatin, etoposide, and cisplatin, work in different ways to stop the growth of tumor cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading.

Pediatric Type 2 Diabetes Mellitus and the effects of Lixisenatide

This study is to establish a safe dose for lixisenatide in children and adolescents of different age-groups and to understand whether lixisenatide has beneficial effects on Type 2 Diabetes Mellitus in children and adolescents.

At present, metformin and insulin are the only drugs with regulatory approval in most countries for the treatment of pediatric diabetes. Because approximately half of youth with Type 2 Diabetes Mellitus fail to maintain glycemic control when treated with metformin either alone or in conjunction with lifestyle interventions, insulin therapy is often required soon after diagnosis. Thus, there is a need for more treatment options for children and adolescents with Type 2 Diabetes Mellitus.

RU011501I: Breast Cancer and of Effects Folate Receptor Alpha Peptide Vaccine, Sargramostim, & Cyclophosphamide

This randomized phase II trial studies how well multi-epitope folate receptor alpha peptide vaccine, sargramostim, and cyclophosphamide work in treating patients with triple negative breast cancer. Vaccines made from a person's white blood cells mixed with tumor proteins may help the body build an effective immune response to kill tumor cells. Drugs used in chemotherapy, such as cyclophosphamide, work in different ways to stop the growth of tumor cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Giving multi-epitope folate receptor alpha peptide vaccine, sargramostim, and cyclophosphamide may work better in treating patients with triple negative breast cancer.

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NRG-GY009: Pegylated Liposomal Doxorubicin + Atezolizumab and/or Bevacizumab for Recurrent Ovarian Cancer

This randomized phase II/III trial studies how well Pegylated Liposomal Doxorubicin Hydrochloride with Atezolizumab and/or Bevacizumab work in treating patients with Ovarian, Fallopian Tube, or Primary Peritoneal Cancer that has come back. Drugs used in chemotherapy, such as Pegylated Liposomal Doxorubicin Hydrochloride, work in different ways to stop the growth of cancer cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Monoclonal Antibodies, such as Atezolizumab and Bevacizumab, may interfere with the ability of tumor cells to grow and spread. It is not yet known which combination will work better in treating patients with Ovarian, Fallopian Tube, or Primary Peritoneal Cancer.

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S1416: Breast Cancer and the Effects of Cisplatin With or Without ABT-888 (Veliparib)

This randomized phase II trial studies how well cisplatin works with or without veliparib in treating patients with stage IV triple-negative breast cancer and/or breast cancer (BRCA) mutation-associated breast cancer. Drugs used in chemotherapy, such as cisplatin, work in different ways to stop the growth of tumor cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Veliparib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. It is not yet known if cisplatin is more effective with or without veliparib in treating patients with triple-negative and/or BRCA mutation-associated breast cancer.

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RENAVIV: Pazopanib With or Without Abexinostat for Locally Advanced or Metastatic Renal Cell Carcinoma

In this randomized, Phase 3, double-blind, placebo-controlled study, patients will be randomized 2:1 to receive either a combination of pazopanib plus abexinostat or pazopanib plus placebo. At the time of disease progression, patient treatment assignment will be unblinded, and those patients randomized to the pazopanib plus placebo treatment arm will have the option of crossing over to receive treatment with a combination of pazopanib plus abexinostat. Patients may continue to receive study drug until any of the following events: the development of IRC-verified radiographic progression, clinical disease progression, unacceptable toxicity, another discontinuation criterion is met, withdrawal of consent, or closure of the study by the sponsor. No maximum duration of therapy has been set.

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S1613: Trastuzumab + Pertuzumab or Cetuximab + Irinotecan for HER2/Neu Amplified Colorectal Cancer

This randomized phase II trial studies how well trastuzumab and pertuzumab work compared to cetuximab and irinotecan hydrochloride in treating patients with HER2/neu amplified colorectal cancer that has spread from where it started to other places in the body and cannot be removed by surgery. Monoclonal antibodies, such as trastuzumab and pertuzumab, may interfere with the ability of tumor cells to grow and spread. Drugs used in chemotherapy, such as cetuximab and irinotecan hydrochloride, work in different ways to stop the growth of tumor cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Giving trastuzumab and pertuzumab may work better compared to cetuximab and irinotecan hydrochloride in treating patients with colorectal cancer.

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S1612: Azacitidine +/- Nivolumab or Midostaurin, or Decitabine and Cytarabine Alone for AML or MDS

This randomized phase II/III trial studies how well azacitidine with or without nivolumab or midostaurin, or decitabine and cytarabine alone work in treating older patients with newly diagnosed acute myeloid leukemia or high-risk myelodysplastic syndrome. Drugs used in chemotherapy, such as azacitidine, decitabine, and cytarabine, work in different ways to stop the growth of cancer cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Monoclonal antibodies, such as nivolumab, may interfere with the ability of cancer cells to grow and spread. Midostaurin may stop the growth of cancer cells by blocking some of the enzymes needed for cell growth. Giving azacitidine with or without nivolumab or midostaurin, or decitabine and cytarabine alone may kill more cancer cells.

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AG120-C-009: AG-120 (Ivosidenib) vs. Placebo with Azacitidine for Previously Untreated AML with IDH1 Mutation

Study AG120-C-009 is a global, Phase 3, multicenter, double-blind, randomized, placebo-controlled clinical trial to evaluate the efficacy and safety of AG-120 (Ivosidenib) + Azacitidine vs Placebo + Azacitidine in adult subjects with previously untreated IDH1m AML who are considered appropriate candidates for non-intensive therapy. The primary endpoint is Overall Survival (OS). The key secondary efficacy endpoints are Event free Survival (EFS), rate of complete remission (CR), Rate of CR and complete remission with partial hematologic recovery (CRh), and overall response rate (ORR). Subjects eligible for study treatment based on Screening assessments will be randomized 1:1 to receive oral AG-120 or matched placebo, both administered in combination with subcutaneous (SC) or intravenous (IV) Azacitidine. An estimated 392 subjects will participate in the study.

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A171601: Palbociclib and Letrozole or Fulvestrant for ER Positive, HER2 Negative Metastatic Breast Cancer

This phase II trial studies the side effects and how well Palbociclib and Letrozole or Fulvestrant works in treating patients aged 70 years and older with estrogen receptor positive, HER2 negative breast cancer that has spread to other places in the body. Palbociclib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Drugs used in chemotherapy, such as Letrozole or Fulvestrant, work in different ways to stop the growth of tumor cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Giving Palbociclib and Letrozole or Fulvestrant may work better in treating patients with breast cancer. The trial will explore factors other than chronologic age that can affect toxicity rates as identified using a cancer-specific geriatric assessment.

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EA2142: Gastroenteropancreatic Neuroendocrine Carcinoma and the Effects of Cisplatin and Etoposide

This randomized phase II trial studies how well temozolomide and capecitabine work compared to standard treatment with cisplatin and etoposide in treating patients with neuroendocrine carcinoma of the gastrointestinal tract or pancreas that has spread to other parts of the body (metastatic) or cannot be removed by surgery. Drugs used in chemotherapy, such as temozolomide, capecitabine, cisplatin, and etoposide, work in different ways to stop the growth of tumor cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Certain types of neuroendocrine carcinomas may respond better to treatments other than the current standard treatment of cisplatin and etoposide. It is not yet known whether temozolomide and capecitabine may work better than cisplatin and etoposide in treating patients with this type of neuroendocrine carcinoma, called non-small cell neuroendocrine carcinoma.

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MIRATI 516-003: Sitravatinib and Nivolumab in Urothelial Carcinoma Study

The study will evaluate the clinical activity of Nivolumab in combination with the investigational agent Sitravatinib in patients with advanced or metastatic Urothelial Carcinoma. Sitravatinib is an orally-available, potent small molecule inhibitor of a closely related spectrum of receptor tyrosine kinases (RTKs) including MET, Axl, MERTK, VEGFR family, PDGFR family, KIT, FLT3, Trk family, RET, DDR2 and selected Eph family members. Nivolumab is a human IgG monoclonal antibody that binds to the programmed cell death-1 (PD-1) receptor and blocks its interaction with programmed cell death ligand-1 (PD-L1) and PD-L2, releasing PD-1 pathway-mediated inhibition of the immune response including anti-tumor immune response. Combining an immunotherapeutic PD-L1 checkpoint inhibitor with an agent that has both immune modulatory and antitumor properties could enhance the antitumor efficacy observed with either agent alone. Sitravatinib selectively inhibits key molecular and cellular pathways strongly implicated in checkpoint inhibitor resistance and therefore represents a rational strategy to enhance or restore anti-tumor immunity when combined with Nivolumab, a checkpoint inhibitor therapy.

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Tracon 253PC101: TRC253, an Androgen Receptor Antagonist, in Metastatic Castration-Resistant Prostate Cancer

This is a multi-center, first-in-human, open-label, Phase 1/2A dose-escalation study in which eligible patients with metastatic castration-resistant prostate carcinoma (mCRPC) will receive oral doses of TRC253. The study will be conducted in 2 parts: part 1 (dose escalation) and part 2 (dose expansion).

The objective of Part 2 is to gather additional information on the safety, pharmacokinetics (PK) and pharmacodynamic (PD) characteristics, and the clinical efficacy of TRC253 in a pre-defined population of patients with metastatic castrate-resistant prostate cancer (mCRPC). Patients enrolled into Part 2 will have received prior treatment with enzalutamide or apalutamide and showed characteristics of acquired resistance based on changes in PSA serum levels. Patients will be centrally screened for the presence of the AR F876L (androgen receptor F876L) mutation from a plasma sample and enrolled into Cohort 1 (AR F876L positive) or Cohort 2 (AR F876L negative). Cohort 2 may be expanded if a specific molecular mechanism sensitizing the mCRPC to TRC253 therapy can be identified retrospectively. Additional patients may be prospectively selected for this specific molecular resistance mechanism and added to Cohort 2 upon recommendation by the medical monitor and Principal Investigators.

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BEST - CLI

The BEST-CLI Trial is a multicenter randomized trial of best endovascular (EVT) or best open surgical (OPEN) revascularization in patients with CLI (Critical Limb Ischemia) and infrainguinal arterial occlusive disease who are candidates for both open and endovascular treatment.

CREST-2

This trial is testing that intensive medical management differs from the combination of CEA and intensive medical management in preventing the primary endpoint in patients with high-grade asymptomatic carotid stenosis and to test that intensive medical management differs from the combination of CAS and intensive medical management in preventing the primary endpoint in patients with high-grade asymptomatic carotid stenosis.