Clinical Trial: ULTRATRACE Iobenguane I 131 in Patients With Malignant Pheochromocytoma, Paraganglioma, or Metastatic Carcinoid

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

Official Title: Phase 1 Study Evaluating the Safety, Distribution, Metabolism, and Radiation Dosimetry of ULTRATRACE Iobenguane I 131 in Patients With Malignant Pheochromocytoma/Paraganglioma

Brief Summary: The purpose of this study is to test the safety of a drug called Ultratrace iobenguane I 131 that has radioactivity, to measure how long it takes for the drug to be absorbed and passed out of the body, and to measure how much radioactivity is absorbed into different tissues of the body.

Detailed Summary: Iobenguane, which is also known as MIBG, has been used in many patients who have types of cancers caused by what are known as neuroendocrine tumors, such as pheochromocytoma, paraganglioma, and carcinoid. Iobenguane is absorbed by neuroendocrine tumor cells. The radioactive portion of the study drug, Ultratrace iobenguane, is a form of iodine called I 131. The I 131 is absorbed into the tumor with the iobenguane, and the radioactivity should kill the tumors. The type of iobenguane being studied is called Ultratrace because of the new way in which this form of iobenguane is made. This study is the first time in which Ultratrace iobenguane will be given to patients. The purpose of the study is to give a low dose of iobenguane just to find out if the drug is safe, to measure how long it takes the drug to be absorbed and passed out of the body, and to see how much radioactivity is absorbed by different types of tissues of the body.
Sponsor: Molecular Insight Pharmaceuticals, Inc.

Current Primary Outcome:

  • whole body imaging immediately post-dose
  • whole body imaging 1 hour post-dose
  • whole body imaging 3 hours post-dose
  • whole body imaging 6 hours post-dose
  • whole body imaging 24 hours post-dose
  • whole body imaging 48 hours post-dose
  • whole body imaging 120 hours post-dose


Original Primary Outcome:

  • whole body imaging immediately post-dose
  • whole body imaging 1 hour post-dose
  • whole body imaging 3 hours post-dose
  • whole body imaging 6 hours post-dose
  • whole body imaging 24 hours post-dose
  • whole body imaging 48 hours post-dose
  • whole body imaging 96 hours post-dose


Current Secondary Outcome:

  • blood and urine samples pre-dose
  • blood and urine samples immediately post-dose
  • blood and urine samples 1 hour post-dose
  • blood and urine samples 3 hours post-dose
  • blood and urine samples 6 hours post-dose
  • blood and urine samples 24 hours post-dose
  • blood and urine samples 48 hours post-dose
  • blood and urine samples 120 hours post-dose
  • continuous urine samples at intervals of 0-6 hours, 6-24 hours, 24-48 hours, 48-72 hours, 72-96 hours and 96-120 hours post-dose
  • monitoring for adverse events starting when the patient consents to be in the study until 2 weeks post-dose


Original Secondary Outcome:

  • blood and urine samples pre-dose
  • blood and urine samples immediately post-dose
  • blood and urine samples 1 hour post-dose
  • blood and urine samples 3 hours post-dose
  • blood and urine samples 6 hours post-dose
  • blood and urine samples 24 hours post-dose
  • blood and urine samples 48 hours post-dose
  • blood and urine samples 96 hours post-dose
  • continuous urine samples at intervals of 0-6 hours, 7-24 hours, 25-48 hours, and 49-96 hours post-dose
  • monitoring for adverse events starting when the patient consents to be in the study until 2 weeks post-dose


Information By: Molecular Insight Pharmaceuticals, Inc.

Dates:
Date Received: June 17, 2006
Date Started: June 2006
Date Completion:
Last Updated: October 7, 2011
Last Verified: October 2011