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| Sponsor: | Molecular Insight Pharmaceuticals, Inc. |
|---|---|
| Information provided by: | Molecular Insight Pharmaceuticals, Inc. |
| ClinicalTrials.gov Identifier: | NCT00458952 |
Purpose
The purpose of this study is to determine whether iobenguane I 131 is safe and effective in patients with malignant pheochromocytoma or paraganglioma.
| Condition | Intervention | Phase |
|---|---|---|
|
Pheochromocytoma Paraganglioma |
Drug: Ultratrace Iobenguane (MIBG) I 131 |
Phase I Phase II |
| Study Type: | Interventional |
| Study Design: | Allocation: Non-Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment |
| Official Title: | A Phase I-II Study Evaluating the Maximum Tolerated Dose, Dosimetry, Safety, and Efficacy of Ultratrace Iobenguane I 131 in Patients With Malignant Pheochromocytoma/Paraganglioma |
| Estimated Enrollment: | 49 |
| Study Start Date: | April 2007 |
| Estimated Study Completion Date: | May 2013 |
| Estimated Primary Completion Date: | June 2009 (Final data collection date for primary outcome measure) |
This is a phase 1 and phase 2 study. The phase 1 patients will be enrolled before the phase 2 patients are enrolled. Each patient will receive a small dose to see if the tumors absorb the drug. If the patient's tumors absorb the drug, then the patient will receive one therapeutic dose. In the phase 1 portion, every 3 patients will be given the same therapeutic dose, and usually each group of 3 patients will be given a larger dose than people who were enrolled before them. Enrollment in the phase 1 portion will be complete once researches believe that they have found the highest dose that they can give patients without causing unacceptable toxicity. This dose is called the maximum tolerated dose (MTD). All phase 2 patients will receive the MTD. Each patient in phase 1 and phase 2 will be followed for 5 years following their therapeutic dose. During this 5-year follow-up period, patients will undergo tests such as 1.) CT or MRI scans and blood and urine tests to determine if the tumors shrink, grow, or stay the same; 2.) bone scans to see if the tumor has spread to or increased in the bones and, 3.) a quality of life test to see how the symptoms of pheochromocytoma or paraganglioma affect patients' daily lives.
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contacts and Locations| United States, Iowa | |
| University of Iowa Medical Center | |
| Iowa City, Iowa, United States, 52242 | |
| United States, Maryland | |
| Johns Hopkins University | |
| Baltimore, Maryland, United States, 21287-0817 | |
| United States, Minnesota | |
| Mayo Clinic | |
| Rochester, Minnesota, United States, 55905 | |
| United States, Missouri | |
| Mallinckrodt Institute of Radiology | |
| St. Louis, Missouri, United States, 63110 | |
| United States, New York | |
| New York Presbyterian Hospital-Weill Cornell Medical Center | |
| New York, New York, United States, 10021 | |
| Mount Sinai School of Medicine | |
| New York, New York, United States, 10029 | |
| United States, North Carolina | |
| Duke University Medical Center | |
| Durham, North Carolina, United States, 27710 | |
| United States, Pennsylvania | |
| Hospital of the University of Pennsylvania | |
| Philadelphia, Pennsylvania, United States, 19104 | |
| United States, Rhode Island | |
| Rhode Island Hospital | |
| Providence, Rhode Island, United States, 02903 | |
| Canada, Alberta | |
| Cross Cancer Institute | |
| Edmonton, Alberta, Canada, T6G 2N8 | |
| Canada, Ontario | |
| London Health Sciences Centre | |
| London, Ontario, Canada, N6A 5W9 | |
| Study Director: | Norman LaFrance, MD | Molecular Insight Pharmaceuticals |
More Information
| Responsible Party: | Jennifer Whalen, Molecular Insight Pharmaceuticals |
| ClinicalTrials.gov Identifier: | NCT00458952 History of Changes |
| Other Study ID Numbers: | MIP-IB12 |
| Study First Received: | April 9, 2007 |
| Last Updated: | June 4, 2009 |
| Health Authority: | United States: Food and Drug Administration; Canada: Health Canada |
|
MIBG iobenguane iodine I 131 radiotherapy radiopharmaceutical |
dosimetry neuroendocrine tumor Ultratrace no carrier added metaiodobenzyl-guanidine |
|
Paraganglioma Pheochromocytoma Neuroendocrine Tumors Neuroectodermal Tumors Neoplasms, Germ Cell and Embryonal Neoplasms by Histologic Type Neoplasms |
Neoplasms, Nerve Tissue 3-Iodobenzylguanidine Antineoplastic Agents Therapeutic Uses Pharmacologic Actions Enzyme Inhibitors Molecular Mechanisms of Pharmacological Action |