NCT01413503

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

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

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 50 (actual)
• Sponsor: University of California, San Francisco · Academic / Other
• Sex: All
• Age: 4 Years
• Healthy volunteers: Not accepted

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 description

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.

Conditions

• Pheochromocytoma
• Paraganglioma

Interventions

Type	Name	Description
RADIATION	131I-MIBG	Therapeutic 131I-MIBG will be synthesized at Nuclear Diagnostic Products (NDP; Rockaway, New Jersey) with specific activities of 9-18 Ci/mmole. The therapeutic dose: 8-12 mCi/kg (maximum 1200 mCi ± 10% at investigator's discretion) will be diluted in 25 ml of normal saline, and will be infused intravenously through a patient's peripheral or central line over 120 minutes. The patient will remain in a radiation protected isolation room until radiation emissions are ≤ 2 mr/hr at a 1 meter distance or meets institutional and state guidelines. This usually takes 4-6 days. In all cases, special shielding will be equipped in the room to minimize exposure to the outside environment and personnel will observe institutional radiation safety precautions.

Timeline

• Start date: 1991-05-01
• Primary completion: 2007-09-06
• Completion: 2009-05-01
• First posted: 2011-08-10
• Last updated: 2018-09-18
• Results posted: 2018-09-18

Locations

1 site across 1 country: United States