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
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.
Interventional
Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Phase1: toxicities (DLTs) in 1st 6 weeks after therapeutic (tx) dose
6 weeks post therapy dose
Yes
Norman LaFrance, MD
Study Director
Molecular Insight Pharmaceuticals
United States: Food and Drug Administration
MIP-IB12
NCT00458952
April 2007
May 2013
Name | Location |
---|---|
Johns Hopkins University | Baltimore, Maryland 21205 |
Mayo Clinic | Rochester, Minnesota 55905 |
Mount Sinai School of Medicine | New York, New York 10029 |
Rhode Island Hospital | Providence, Rhode Island 02903 |
Mallinckrodt Institute of Radiology | Saint Louis, Missouri 63110 |
Duke University Medical Center | Durham, North Carolina 27710 |
Hospital of the University of Pennsylvania | Philadelphia, Pennsylvania 19104 |
University of Iowa Medical Center | Iowa City, Iowa 52242 |
New York Presbyterian Hospital-Weill Cornell Medical Center | New York, New York 10021 |