Ignite Creation Date:
2025-12-24 @ 9:58 PM
Ignite Modification Date:
2025-12-30 @ 5:11 PM
Study NCT ID:
NCT01377532
Status:
APPROVED_FOR_MARKETING
Last Update Posted:
2020-05-06
First Post:
2011-06-13
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Compassionate Use of 131I-MIBG for Patients With Malignant Pheochromocytoma
Sponsor:
University of California, San Francisco
Organization:
Study Overview
Official Title:
Compassionate Use of 131I-MIBG for Patients With Malignant Pheochromocytoma
Status:
APPROVED_FOR_MARKETING
Status Verified Date:
2020-05
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
This is a compassionate use protocol to allow palliative therapy for patients with malignant pheochromocytoma and paragangliomas.
Detailed Description:
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.
Study Oversight
Has Oversight DMC:
Is a FDA Regulated Drug?:
Is a FDA Regulated Device?:
Is an Unapproved Device?:
Is a PPSD?:
Is a US Export?:
Is an FDA AA801 Violation?: