Clinical Trial: Phase 1 Study of Iobenguane (MIBG) I 131 in Patients With Malignant Pheochromocytoma/Paraganglioma

Study Status: Completed
Recruit Status: Completed
Study Type: Interventional

Official Title: A Phase I Study Evaluating the Maximum Tolerated Dose, Dosimetry, Safety, and Efficacy of Ultratrace Iobenguane I 131 in Patients With Malignant Pheochromocytoma/Paraganglioma

Brief Summary: The purpose of this study is to determine whether iobenguane I 131 is safe and effective in patients with malignant pheochromocytoma or paraganglioma.

Detailed Summary: This was originally designed as a phase 1/2 study. The phase 1 patients received a small dose of study drug to see if the tumors absorb the drug. If the patient's tumors absorbed the drug, then the patient received one therapeutic dose. In the phase 1 portion, the study employed a 3 + 3 dose escalation design. Enrollment in the phase 1 portion was to be completed once researches believed that they found the highest dose that they could give patients without causing unacceptable toxicity. This dose is called the maximum tolerated dose (MTD). Following discussions with the Food and Drug Administration (FDA) that occurred during the dose escalation stage of the study, the protocol was amended to conclude the trial upon the identification of the MTD. The Phase 2 safety/ efficacy stage of the study was conducted with modifications of the primary endpoint as Protocol MIP IB12B, with Special Protocol Assessment Agreement with the FDA in March 2009.
Sponsor: Molecular Insight Pharmaceuticals, Inc.

Current Primary Outcome: MTD of Ultratrace Iobenguane I 131 [ Time Frame: 6 weeks post therapy dose ]

Although no primary efficacy endpoint was defined for this study, the MTD of Ultratrace iobenguane I 131 in patients with malignant pheochromocytoma/paraganglioma (a safety rather than an efficacy parameter) is the primary objective.


Original Primary Outcome:

  • Phase1: Toxicities (DLTs) in 1st 6 Weeks After Therapeutic (tx) Dose
  • Phase2: tumor response by CT/MRI 9 months after tx dose


Current Secondary Outcome:

Original Secondary Outcome:

  • Phase1: radiation absorbed 1 hour after dose 1(small dose), 2-4 days after dose 1, and 5-7 days after dose 1; tumor response by CT/MRI & blood/urine tests 3, 6, 9, & 12 months after tx dose; dose response by CT/MRI 9 months after tx dose
  • Phase2: tumor response by CT/MRI & blood/urine tests 3, 6, 9, & 12 month after tx dose; quality of life 3, 6, 9, & 12 months after tx dose


Information By: Molecular Insight Pharmaceuticals, Inc.

Dates:
Date Received: April 9, 2007
Date Started: April 2007
Date Completion:
Last Updated: June 13, 2016
Last Verified: June 2016