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Sponsored by: |
M.D. Anderson Cancer Center |
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Information provided by: | M.D. Anderson Cancer Center |
ClinicalTrials.gov Identifier: | NCT00037869 |
The goal of this clinical research study is to learn if I-131 Metaiodobenzylguanidine (MIBG) can shrink or slow the growth of the tumor(s) in patients with metastatic neuroendocrine tumors. The safety of this treatment will also be studied.
Condition | Intervention | Phase |
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Neuroendocrine Tumors Metastases, Neoplasm |
Drug: I-131 Metaiodobenzylguanidine |
Phase III |
Study Type: | Interventional |
Study Design: | Treatment, Non-Randomized |
Study Start Date: | November 2001 |
Estimated Study Completion Date: | November 2004 |
MIBG is used to visualize a group of specific cells in the body. It has been known to deliver the radioactive iodine to the tumor (cancer) cells selectively and result in their destruction.
Before treatment starts, patients will be evaluated with a tracer scan, using either I-131 MIBG or I-123 MIBG to locate the tumor site(s). If no MIBG accumulation can be found within tumor sites, the patient will not be able to continue on this study. Patients will also have CT scans and urine and blood tests. Women able to have children will have a pregnancy test.
If tumor sites are found and patients are fully eligible, they will receive a therapeutic (treatment) dose of I-131 MIBG by vein over 120 minutes. Some patients may have to receive a lower dose of MIBG. Patients will require hospitalization for treatment and will remain hospitalized for about 3-6 days.
Ages Eligible for Study: | 2 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
INCLUSION:
Diagnostic criteria- Patients must meet all of the following:
EXCLUSION:
Study ID Numbers: | ID01-063 |
Study First Received: | May 24, 2002 |
Last Updated: | June 23, 2005 |
ClinicalTrials.gov Identifier: | NCT00037869 |
Health Authority: | United States: Food and Drug Administration |
Metastatic neuroendocrine tumors |
Neuroectodermal Tumors 3-Iodobenzylguanidine Neoplasms, Germ Cell and Embryonal |
Neoplasm Metastasis Neuroepithelioma Neuroendocrine Tumors |
Neoplasms Neoplastic Processes Neoplasms by Histologic Type Pathologic Processes Molecular Mechanisms of Pharmacological Action |
Antineoplastic Agents Therapeutic Uses Neoplasms, Nerve Tissue Enzyme Inhibitors Pharmacologic Actions |