Clinical Trials

This randomized phase II trial studies how well atezolizumab and capecitabine with or without bevacizumab work in treating patients with colorectal cancer that is not responding to treatment and has spread to other places. Monoclonal antibodies, such as atezolizumab and bevacizumab, may interfere with the ability of tumor cells to grow and spread. Drugs used in chemotherapy, such as capecitabine, 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 with capecitabine and bevacizumab may be a better way in treating colorectal cancer.

The primary objective of this study is to provide access to [Ga-68] PSMA-11 imaging (PET/CT or PET/MR) for patients diagnosed with untreated high-risk prostate cancer or biochemically recurrent prostate cancer.

The purpose of this study to assess the effectiveness of proton vs. photon therapy in reducing major cardiovascular events (MCE), defined as atherosclerotic coronary heart disease or other heart disease death, myocardial infarction, coronary revascularization, or hospitalization for major cardiovascular event (heart failure, valvular disease, arrhythmia, or unstable angina or other major cardiovascular event) in patients with locally-advanced breast cancer.

The purpose of this trial is to study how well tazemetostat works in treating patients with ovarian, primary peritoneal, or endometrial cancer that has come back. Drugs used in chemotherapy, such as tazemetostat, 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.

The treatment for postmenopausal women diagnosed with hormone receptor positive (HR+) metastatic breast cancer (mBr) includes endocrine therapy However, de novo or acquired resistance to endocrine therapy remains an important clinical problem. Many hormone receptor positive breast cancers demonstrate overexpression of cyclin D. Cyclin D interacts directly with cyclin-dependent kinases 4 and 6 (CDK4/6) in an active protein complex that promotes cell proliferation; and consequently, CDK4/6 represents a potential therapeutic target for HR+ breast cancers.

LY2835219 represents a selective and potent small molecule inhibitor of CDK4/6. LY2835219 demonstrates suitable physical and pharmacokinetic (PK) properties, an acceptable toxicity profile in nonclinical species, and antitumor activity in multiple mouse models of human cancer,. LY2835219 inhibits tumor growth in multiple human xenograft models including, but not limited to, the following tumor types: 1) colorectal cancer, 2) glioblastoma multiforme, 3) acute myeloid leukemia, 4) non-small cell lung cancer, and 5) mantle cell lymphoma (MCL).

Importantly, LY2835219 has demonstrated early evidence of single-agent activity against HR+ mBC in study I3Y-MC-JPBA. I3Y-MC-JPBA is being amended to include an expanded cohort of postmenopausal women with disease progression following antiestrogen therapy who are receiving fulvestrant. The Phase 1b study I3Y-MC-JPBH (JPBH) will further evaluate the safety and tolerability of LY2835219 in combination with hormone therapies for patients with advanced and/or HR+ mBC.

This randomized phase II trial studies how well carboplatin and paclitaxel with or without atezolizumab before surgery works in treating patients with newly diagnosed, stage II-III triple negative breast cancer. Monoclonal antibodies, such as atezolizumab, may block tumor growth in different ways by targeting certain cells. Drugs used in chemotherapy, such as carboplatin and paclitaxel, 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 carboplatin and paclitaxel with or without atezolizumab before surgery may make the tumor smaller and reduce the amount of normal tissue that needs to be removed.

This randomized phase III trial was originally designed to compare three different combination chemotherapy regimens to see how well they work. As of September 1, 2004, the study was expanded to a total of 6 arms (the original 3 arms (A, B, C) and 3 additional arms which were the same as the first 3 but with cetuximab) in treating patients who have undergone surgery for stage III colon cancer. Drugs used in chemotherapy, such as irinotecan hydrochloride, fluorouracil, leucovorin calcium, and oxaliplatin, work in different ways to stop tumor cells from dividing so they stop growing or die. Monoclonal antibodies such as cetuximab can locate tumor cells and either kill them or deliver tumor-killing substances to them without harming normal cells. Combining more than one chemotherapy drug with monoclonal antibody therapy and giving them after surgery may kill any remaining tumor cells. It was not known at the time this study was developed which combination chemotherapy regimen is more effective after surgery in treating colon cancer. This study had several key changes, based on the results of other phase III trials. As of 6/1/2005, patients no longer received irinotecan on this study and treatment arms B, C, E, and F were discontinued. Patients on arms B and C crossed to arm A. Patients on arms E and F crossed to arm D. Patients on arms C and F who had not gotten to irinotecan continued on arms A and D, respectively. As of 8/18/2008, pre-screening for Kirsten rat sarcoma (KRAS) status was added with mutant KRAS (or KRAS not evaluable) patients put on arm G and wild-type KRAS patients randomized between arm A and arm D. Patients on arm G were treated per physician discretion and followed for disease and survival status. KRAS was determined in a central laboratory and was process for all patients on this study. The primary endpoint of this study was modified on 8/18/2008 to focus on patients having wild-type KRAS tumors. All modifications were approved by the Central Institution Review Board, local Institutional Review Boards, NCI, and the NCCTG Data Safety Monitoring Board.

The purpose of this study is to test the safety of an investigational drug called LB 100 for Injection for treatment of solid tumors, when given with or without docetaxel. LB-100 is a small molecule that in laboratory and animal studies has shown activity when used by itself or together with drugs approved to treat some types of cancer (chemotherapeutic agents). Docetaxel is a drug that has been approved for the treatment of some types of cancer; one of the trade names for docetaxel is Taxotere®. The study is in 2 parts. Part 1: Patients will receive injections of LB-100. Part 2: Patients will receive injections of LB-100 and docetaxel. This is the first study where LB-100 for Injection will be used in humans.

This randomized phase II trial studies how well olaparib and atezolizumab work either alone or in combination in treating patients with stage III-IV triple negative breast cancer. Olaparib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Monoclonal antibodies, such as atezolizumab, may interfere with the ability of tumor cells to grow and spread. It is not known whether giving olaparib and atezolizumab either alone or in combination would work better in patients with triple negative breast cancer.

The purpose of this study is to determine safety and measure biodistribution of  two imaging agents in patients with refractory or metastatic melanoma. This study will use [203Pb]VMT01 for Single Photon Emission Computed Tomography (SPECT) imaging and [68Ga]VMT02 for Positron Emission Tomography (PET) imaging.