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This phase II trial studies the effect of lutetium Lu 177 dotatate compared to the usual treatment (everolimus) in treating patients with somatostatin receptor positive bronchial neuroendocrine tumors that have spread to other places in the body (advanced). Lutetium Lu 177-dotate is a radioactive drug. It binds to a protein called somatostatin receptor, which is found on some neuroendocrine tumor cells. Lutetium Lu 177-dotatate builds up in these cells and gives off radiation that may kill them. It is a type of radioconjugate and a type of somatostatin analog. Lutetium Lu 177 dotatate may be more effective than everolimus in shrinking or stabilizing advanced bronchial neuroendocrine tumors.
This phase III trial compares the combination of four drugs (daratumumab, bortezomib, lenalidomide and dexamethasone) to the use of a three drug combination (daratumumab, lenalidomide and dexamethasone). Bortezomib may stop the growth of cancer cells by blocking some of the enzymes needed for cell growth. Chemotherapy drugs, such as lenalidomide, 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. Daratumumab is a monoclonal antibody that may interfere with the ability of cancer cells to grow and spread. Anti-inflammatory drugs, such as dexamethasone lower the body's immune response and are used with other drugs in the treatment of some types of cancer. Adding bortezomib to daratumumab, lenalidomide, and dexamethasone may be more effective in shrinking the cancer or preventing it from returning, compared to continuing on daratumumab, lenalidomide, and dexamethasone.

Thatcher Heumann, M.D., M.P.H.

  • Assistant Professor of Medicine

Thatcher Heumann, M.D., M.P.H.

  • Assistant Professor of Medicine

thatcher.heumann@vumc.org

Research Program

Research Description

Have any questions? Contact Us 1-877-936-8422 for more information
This phase II trial tests whether using genetic testing of tumor tissue to select the optimal treatment regimen works in treating patients with clear cell renal cell (kidney) cancer that has spread to other places in the body (advanced or metastatic). The current Food and Drug Administration (FDA)-approved regimens for advanced kidney cancer fall into two categories. One treatment combination includes two immunotherapy drugs (nivolumab plus ipilimumab), which are delivered by separate intravenous infusions into a vein. The other combination is one immunotherapy drug (nivolumab infusion) plus an oral pill taken by mouth (cabozantinib). Nivolumab and ipilimumab are "immunotherapies" which release the brakes of the immune system, thus allowing the patient's own immune system to better kill cancer cells. Cabozantinib is a "targeted therapy" specifically designed to block certain biological mechanisms needed for growth of cancer cells. In kidney cancer, cabozantinib blocks a tumor's blood supply. The genetic (DNA) makeup of the tumor may affect how well it responds to therapy. Testing the makeup (genes) of the tumor, may help match a treatment (from one of the above two treatment options) to the specific cancer and increase the chance that the disease will respond to treatment. The purpose of this study is to learn if genetic testing of tumor tissue may help doctors select the optimal treatment regimen to which advanced kidney cancer is more likely to respond.
This is an open-label study. This means that people in this study and clinic staff will know that people will receive ASP3082. The study aims to check how safe and well-tolerated ASP3082 is for people with advanced solid tumors that have a specific mutation called KRAS G12D. This study will be in 2 parts. In Part 1, different small groups of people will receive lower to higher doses of ASP3082 by itself, or together with cetuximab. Any medical problems will be recorded at each dose. This is done to find suitable doses of ASP3082, by itself or together with cetuximab, to use in Part 2 of the study. The first group will receive the lowest dose of ASP3082. A medical expert panel will check the results from this group and decide if the next group can receive a higher dose of ASP3082. The panel will do this for each group until all groups have received ASP3082 (by itself or together with cetuximab) or until suitable doses have been selected for Part 2. In Part 2, ASP3082 will be given in by itself, or in combination with the other study treatments. Study treatments will be given through a vein. This is called an infusion. Each treatment cycle is 21 or 28 days long. They will continue treatment until: they have medical problems from the treatment they can't tolerate; their cancer gets worse; they start other cancer treatment; or they ask to stop treatment.
This Phase II/III trial will evaluate the what kind of chemotherapy to recommend to patients based on the presence or absences of circulating tumor DNA (ctDNA) after surgery for colon cancer.

Richard Mu, Ph.D.

  • Research Professor of Biomedical Engineering
  • Tennessee State University

Richard Mu, Ph.D.

  • Research Professor of Biomedical Engineering
  • Tennessee State University

615-963-5527

richard.mu@Vanderbilt.Edu

Research Program

Have any questions? Contact Us 1-877-936-8422 for more information

Mark Mcclain, Ph.D.

  • Research Professor of Medicine

Mark Mcclain, Ph.D.

  • Research Professor of Medicine

615-343-3033

mark.s.mcclain@Vanderbilt.Edu

Research Program

Research Description

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Todd Peterson, Ph.D.

  • Associate Professor Radiology & Radiological Sciences

Todd Peterson, Ph.D.

  • Associate Professor Radiology & Radiological Sciences

615-322-2648

todd.e.peterson@vumc.org

Research Program

Research Description

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Adam Rosenberg, Ph.D.

  • Research Associate Professor of Radiology & Radiological Sciences
  • Director of Radiochemistry Research, Vanderbilt University Institute of Imaging Science

Phone

615-875-0929

Email

adam.j.rosenberg@vumc.org
1161 21st. Ave S.
Nashville, TN 37232

Adam Rosenberg, Ph.D.

  • Research Associate Professor of Radiology & Radiological Sciences
  • Director of Radiochemistry Research, Vanderbilt University Institute of Imaging Science

615-875-0929

adam.j.rosenberg@vumc.org

1161 21st. Ave S.
Nashville, TN 37232

Research Program

Research Description

Have any questions? Contact Us 1-877-936-8422 for more information
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