Clinical Trial: Compassionate Use of 131I-MIBG for Patients With Malignant Pheochromocytoma

Study Status: Available
Recruit Status: Available
Study Type: Expanded Access

Official Title: Compassionate Use of 131I-MIBG for Patients With Malignant Pheochromocytoma

Brief Summary: This is a compassionate use protocol to allow palliative therapy for patients with malignant pheochromocytoma and paragangliomas.

Detailed Summary: Pheochromocytomas (PHEO) and paragangliomas (PGL) are rare tumors, with an incidence of 2-8 cases per million annually. These tumors develop in both children and adults. About 15-20% metastasize. Chemotherapy for this tumor usually consists of a combination of cyclophosphamide, vincristine, and dacarbazine delivered over two days and repeated every 3 weeks. Such combined chemotherapy is ineffective for the majority of patients with metastatic PHEO/PGL. A few patients with malignant PHEO have experienced remissions with sunitinib, but the drug may produce severe toxicity and the experience with that drug is limited. Those patients who do experience a remission with chemotherapy must continue it indefinitely to stay in remission. However, most such patients experience such severe side effects from the chemotherapy (marrow suppression, neuropathy, etc) that their chemotherapy must be discontinued. Thus, chemotherapy is either ineffective or intolerable for the vast majority of patients with metastatic PHEO/PGL.
Sponsor: University of California, San Francisco

Current Primary Outcome:

Original Primary Outcome: Evaluation for response [ Time Frame: 2-4 months post treatment ]

Volumetric measurable disease will be assessed with the same modality (MRI or CT scan) as was performed at the on study evaluation


Current Secondary Outcome:

Original Secondary Outcome:

Information By: University of California, San Francisco

Dates:
Date Received: June 13, 2011
Date Started: August 2009
Date Completion: August 2021
Last Updated: December 23, 2014
Last Verified: December 2014