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Sponsored by: |
Molecular Insight Pharmaceuticals, Inc. |
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Information provided by: | Molecular Insight Pharmaceuticals, Inc. |
ClinicalTrials.gov Identifier: | NCT00458952 |
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: | Treatment, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Safety/Efficacy Study |
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: | April 2012 |
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.
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
United States, Iowa | |
University of Iowa Medical Center | Not yet recruiting |
Iowa City, Iowa, United States, 52242 | |
Contact: Stacy Michael 319-335-8966 stacy-michael@uiowa.edu | |
Contact: Thomas O'Dorisio, M.D. 319-353-7812 thomas-odorisio@uiowa.edu | |
Principal Investigator: Thomas O'Dorisio, M.D. | |
United States, Maryland | |
Johns Hopkins University | Not yet recruiting |
Baltimore, Maryland, United States, 21287-0817 | |
Contact: Yetty Olagbemiro yolagbe1@jhmi.edu | |
Contact: Nicole Cooper ncooper2@jhmi.edu | |
Principal Investigator: Richard L. Wahl, M.D. | |
United States, Minnesota | |
Mayo Clinic | Not yet recruiting |
Rochester, Minnesota, United States, 55905 | |
Contact: Terry Brinkman 507-266-8330 brinkman.terry@mayo.edu | |
Contact: Gregory Wiseman 507-284-9599 gwiseman@mayo.edu | |
Principal Investigator: Gregory Wiseman, M.D. | |
United States, Missouri | |
Mallinckrodt Institute of Radiology | Not yet recruiting |
St. Louis, Missouri, United States, 63110 | |
Contact: Jennifer Frye 314-747-1604 fryej@mir.wustl.edu | |
Contact: Perry W. Grigsby, M.D. 314-362-8502 pgrigsby@radonc.wustl.edu | |
Principal Investigator: Perry W. Grigsby, M.D. | |
United States, New York | |
New York Presbyterian Hospital-Weill Cornell Medical Center | Recruiting |
New York, New York, United States, 10021 | |
Contact: Shankar Vallabhajosula, M.D. 212-746-5694 svallabh@med.cornell.edu | |
Contact: Zubaida Rahman, R.Ph. zur9002@nyp.org | |
Principal Investigator: Stanley Goldsmith, M.D. | |
Mount Sinai School of Medicine | Not yet recruiting |
New York, New York, United States, 10029 | |
Contact: Lale Kostakoglu, M.D. 212-241-6319 lale.kostakoglu@msnyuhealth.org | |
Principal Investigator: Lale Kostakoglu, M.D. | |
United States, North Carolina | |
Duke University Medical Center | Recruiting |
Durham, North Carolina, United States, 27710 | |
Contact: Edward Coleman, M.D. 919-684-7244 colem010@mc.duke.edu | |
Contact: Beth Parente 919-970-1467 beth.parente@duke.edu | |
Principal Investigator: Edward Coleman, M.D. | |
United States, Pennsylvania | |
Hospital of the University of Pennsylvania | Not yet recruiting |
Philadelphia, Pennsylvania, United States, 19104 | |
Contact: Alex Wills 215-662-3049 eze.wills@uphs.upenn.edu | |
Contact: Chaitanya Divgi, M.D. 215-615-3687 chaitanya.divgi@uphs.upenn.edu | |
Principal Investigator: Chaitanya Divgi, M.D. | |
United States, Rhode Island | |
Rhode Island Hospital | Recruiting |
Providence, Rhode Island, United States, 02903 | |
Contact: Elizabeth Morrell 401-444-2277 emorrell@lifespan.org | |
Contact: Richard B. Noto, M.D. 401-444-5184 rnoto@lifespan.org | |
Principal Investigator: Richard B. Noto, M.D. | |
Canada, Alberta | |
Cross Cancer Institute | Not yet recruiting |
Edmonton, Alberta, Canada, T6G 2N8 | |
Contact: Margaret Landon 780-432-8751 margland@cancerboard.ab.ca | |
Contact: Gail Amyotte 780-432-8202 gaila@cancerboard.ab.ca | |
Principal Investigator: Alexander J. McEwan, M.D. | |
Canada, Ontario | |
London Health Sciences Centre | Not yet recruiting |
London, Ontario, Canada, N6A 5W9 | |
Contact: Patty Laverty (519)685-8500 ext 76068 Patricia.Laverty@lhsc.on.ca | |
Contact: Susan Vandermark Susan.Vandermark@lhsc.on.ca | |
Principal Investigator: Robert Reid, M.D. |
Study Director: | Norman LaFrance, MD | Molecular Insight Pharmaceuticals |
Responsible Party: | Molecular Insight Pharmaceuticals ( Jennifer Whalen ) |
Study ID Numbers: | MIP-IB12 |
Study First Received: | April 9, 2007 |
Last Updated: | December 8, 2007 |
ClinicalTrials.gov Identifier: | NCT00458952 |
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 |
Neuroectodermal Tumors Paraganglioma 3-Iodobenzylguanidine Neoplasms, Germ Cell and Embryonal |
Iodine Neuroepithelioma Pheochromocytoma Neuroendocrine Tumors |
Neoplasms Neoplasms by Histologic Type Molecular Mechanisms of Pharmacological Action Antineoplastic Agents |
Therapeutic Uses Neoplasms, Nerve Tissue Enzyme Inhibitors Pharmacologic Actions |