Neuroendocrine Tumor Gastrointestinal, Hormone-Secreting Clinical Trial
Official title:
Phase 1 Trial Using 131I MIBG and 90Y DOTATOC in a Dosimetrically Determined Optimal Combination for Therapy of Selected Patients With Midgut Neuroendocrine Tumors.
This study is designed to identify the best tolerated doses of [131]Iodine-MIBG and [90]Yttrium-DOTATOC when co-administered to treat midgut neuroendocrine tumors. These drugs (131I-MIBG, 90Y-DOTATOC) are radioactive drugs, known as radionuclide therapy. Currently, the safest and best tolerated doses of these drugs (when combined together) is unknown.
[131]Iodine-MIBG and [90]Yttrium-DOTATOC are radioactive drugs designed to treat specific tumor cells. These drugs are a combination of the radiation (131-Iodine, 90-Yttrium) and a protein that targets the tumor cell (MIBG or DOTATOC). Because these proteins are attracted to, and stick to, the tumor, the radiation is centered in the tumors. This kills more tumor cells and minimizes radiation-damage to healthy tissues, like the heart and lungs. Two organs still absorb some of the radiation, though: bone marrow and the kidney. These organs limit how much radiation can be given to tumors, but we don't know how much radiation is too much. Too much radiation to bone marrow can result in anemia. Too much radiation to the kidneys can result in kidney failure. From prior radiation therapies, we have a general idea of how much radiation we can give safely. 131I-MIBG and 90Y-DOTATOC have never been given together. We want to give them together because many times, tumors are actually groups of different types of cells. This means, not all the cells respond to therapy the same way. If some tumor cells survive therapy, the tumor will continue to grow and eventually come back. We know some mid-gut neuroendocrine tumors (NETs) have targets for DOTATOC and some other mid-gut NETs have targets for MIBG. We also have now identified that some people with mid-gut NETs have different tumors: some with targets for MIBG and some with targets for DOTATOC. For these people, this means treating only with 131I-MIBG or 90Y-DOTATOC will not be enough to treat their cancer. They need both radioactive drugs. Because we are combining these radioactive drugs, this study is known as a first-in-man study. We are also using a special imaging to help us estimate the radiation dose to the bone marrow and to the kidneys. This is what decides the final dose of 131I-MIBG and 90Y-DOTATOC. Before receiving therapy, participants will be asked to undergo imaging to verify they have both MIBG and DOTATOC tumor types: - participants are given very small doses of radioactive drugs - a special camera (SPECT/CT) collects images (scans) - imaging (scans) are done over 3 calendar days - blood samples are taken at that time, too, to measure the circulating amount of tracer doses If the scans show a participant has both MIBG and DOTATOC tumors, therapy is given: - a customized dose of 90Y-DOTATOC is given on day 1 of a treatment cycle. This is given outpatient. - a customized dose of 131I-MIBG is given on day 2 of a treatment cycle. This is given inpatient (admitted to the hospital). - participants are monitored through blood tests to identify the side effects of therapy. Each participant can have up to 2 cycles of therapy. The cycles are 12 weeks apart. The doses for 90Y-DOTATOC and 131I-MIBG are decided based on radiation to the bone marrow and radiation to the kidney. Doses are decided by how well other participants have done on this study. Participants have life long follow-up for this study. This is very important, because a study like this has not been done. ;
| Status | Clinical Trial | Phase | |
|---|---|---|---|
| Active, not recruiting |
NCT02724540 -
Randomized Embolization Trial for NeuroEndocrine Tumor Metastases To The Liver
|
Phase 2 |