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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). Radioactive drugs, such as lutetium Lu 177 dotatate, may carry radiation directly to tumor cells and may reduce harm to normal cells. 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-hyaluronidase, bortezomib, lenalidomide and dexamethasone) to the use of a three-drug combination (daratumumab-hyaluronidase, lenalidomide and dexamethasone) in patients with newly diagnosed multiple myeloma. 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-hyaluronidase 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 bodys immune response and are used with other drugs in the treatment of some types of cancer. Adding bortezomib to daratumumab-hyaluronidase, lenalidomide, and dexamethasone may be more effective in shrinking the cancer or preventing it from returning, compared to continuing on a combination of daratumumab-hyaluronidase, lenalidomide, and dexamethasone in patients with newly diagnosed multiple myeloma.

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 tumors 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.
Genes contain genetic code which tell the body which proteins to make. Many types of cancer are caused by changes, or mutations, in a gene called KRAS. Researchers are looking for ways to stop the actions of abnormal proteins made from the mutated KRAS gene. The so-called G12D mutation in the KRAS gene is common in people with some solid tumors. ASP3082 is a potential new treatment for certain solid tumors in people who have the G12D mutation in their KRAS gene. Before ASP3082 is available as a treatment, the researchers need to understand how it is processed by and acts upon the body. This information will help find a suitable dose and to check for potential medical problems from the treatment. People in this study will be adults with locally advanced, unresectable or metastatic solid tumors with the G12D mutation in their KRAS gene (G12D mutation). Locally advanced means the cancer has spread to nearby tissue. Unresectable means the cancer cannot be removed by surgery. Metastatic means the cancer has spread to other parts of the body. They will have been previously treated with standard therapies or refused to receive those treatments. In the European Union (EU) and South Korea, people who have refused to receive treatment with standard therapies cannot take part. The main aims of the study are: to check the safety of ASP3082 by itself and together with cetuximab (a common cancer medicine), how well it is tolerated, and to find a suitable dose of ASP3082 by itself and together with cetuximab. This is an open-label study. This means that people in this study and clinic staff will know that they will receive ASP3082. 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. Only people with colorectal cancer will receive ASP3082 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, other different small groups of people will receive ASP3082 by itself or together with cetuximab, with the most suitable doses worked out from Part 1. This will help find a more accurate dose of ASP3082 to use in future studies. ASP3082, and cetuximab (if used), will be given through a vein. This is called an infusion. Each treatment cycle is 21 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; they ask to stop treatment; they do not come back for treatment. People will visit the clinic on certain days during their treatment, with extra visits during the first 2 cycles of treatment. During these visits, the study doctors will check for any medical problems from ASP3082 by itself or together with cetuximab. At some visits, other checks will include a medical examination, echocardiogram (ECHO) or multigated acquisition (MUGA) scan, blood and urine tests and vital signs. Vital signs include temperature, pulse, breathing rate, and blood pressure. (Blood oxygen levels will also be checked for people treated with ASP3082 together with cetuximab.) Tumor samples will be taken during certain visits during treatment and when treatment has finished. People will visit the clinic within 7 days after stopping treatment. The study doctors will check for any medical problems from ASP3082 by itself or together with cetuximab. Other checks will include a medical examination, echocardiogram (ECHO) or multigated acquisition (MUGA) scan, urine and blood tests and vital signs. After this, people will continue to visit the clinic every 9 weeks. This is to check the condition of their cancer. They will do this until 45 weeks after treatment stopped, or if their cancer is worse, they start other cancer treatment, they ask to stop treatment, or they do not come back for treatment. Also, people may visit the clinic at 30 days and 90 days after stopping treatment. At the 30-day visit, the study doctors will check for any medical problems from ASP3082 by itself or together with cetuximab. People will have their vital signs checked and have some bloo
This phase II/III trial aims to determine the type of chemotherapy that will benefit patients who have had surgery for their stage II or III colon cancer based on presence or absence of circulating tumor deoxyribonucleic acid (ctDNA). In ctDNA positive patients, this trial compares the effect of usual chemotherapy versus mFOLFIRINOX. In ctDNA negative patients, this trial compares the effect of usual chemotherapy versus ctDNA testing every 3 months to determine which approach might be better to prevent colon cancer from returning. Oxaliplatin is in a class of medications called platinum-containing antineoplastic agents. It works by damaging cells DNA and may kill cancer cells. Leucovorin is in a class of medications called folic acid analogs. It works by protecting healthy cells from the effects of chemotherapy medications while allowing chemotherapy agent to enter and kill cancer cells. Fluorouracil is in a class of medications called antimetabolites. It stops cells from making DNA and may slow or stop the growth of cancer cells. Capecitabine is in a class of medications called antimetabolites. It Is taken up by cancer cells and breaks down to a substance that kills cancer cells. Irinotecan is in a class of antineoplastic medications called topoisomerase I inhibitors. It works by stopping the growth of cancer cells. This trial may help doctors determine what kind of chemotherapy to recommend to colon cancer patients based on the presence or absence of 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

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

Adam Rosenberg, Ph.D.

Phone

615-875-0929

Email

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

Adam Rosenberg, Ph.D.

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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