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

PHASE2CompletedINTERVENTIONAL
Enrollment

50

Participants

Timeline

Start Date

May 31, 1991

Primary Completion Date

September 6, 2007

Study Completion Date

May 31, 2009

Conditions
PheochromocytomaParaganglioma
Interventions
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.

Trial Locations (1)

94103

UCSF, San Francisco

All Listed Sponsors
lead

University of California, San Francisco

OTHER

NCT01413503 - A Phase II Study of 131I- Metaiodobenzylguanidine (MIBG) for Treatment of Metastatic or Unresectable Pheochromocytoma and Related Tumors | Biotech Hunter | Biotech Hunter