Clinical Trial: A Phase II Study of 131I- Metaiodobenzylguanidine (MIBG) for Treatment of Metastatic or Unresectable Pheochromocytoma and Related Tumors

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

Official Title: A Phase II Study of 131I-labeled Metaiodobenzylguanidine (MIBG) for Treatment of Patients With Metastatic or Unresectable Pheochromocytoma and Related Tumors

Brief Summary: This is an ongoing prospective Phase II clinical trial evaluating the efficacy of 131I-MIBG for the treatment of patients with metastatic or unresectable pheochromocytoma and related tumors.

Detailed Summary:

  1. To assess the efficacy of high-dose 131I-MIBG in the treatment of patients with malignant pheochromocytoma and related tumors, with the basis of this initial examination being the percentage of patients in CR or PR, and the percentage of patients without PD for 3 years after the initial administration on 131I-MIBG therapy.
  2. To describe the response rate of malignant pheochromocytoma patients treated with high-dose 131I-MIBG.
  3. To describe the toxicity of high-dose 131I-MIBG in patients with malignant pheochromocytoma.
  4. To describe the overall survival and failure-free survival of malignant pheochromocytoma patients treated with high-dose 131I-MIBG.
  5. To determine the utility of using the serum level of Chromogranin A as a tumor marker for patients with malignant pheochromocytoma.

Sponsor: University of California, San Francisco

Current Primary Outcome: Post 131I-MIBG Evaluation [ Time Frame: 3 months after therapy ]

Patients will be evaluated for disease response.


Original Primary Outcome: Same as current

Current Secondary Outcome:

Original Secondary Outcome:

Information By: University of California, San Francisco

Dates:
Date Received: August 8, 2011
Date Started: May 1991
Date Completion:
Last Updated: January 9, 2015
Last Verified: January 2015