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AVAILABLE
NCT01370330

131I-Labeled MIBG for Refractory Neuroblastoma: A Compassionate Use Protocol

Sponsor: Kieuhoa Vo

View on ClinicalTrials.gov

Summary

This is a compassionate use protocol to allow patients with advanced neuroblastoma palliative access to 131I-metaiodobenzylguanidine (131I-MIBG).

Key Details

Gender

All

Age Range

1 Year - Any

Study Type

EXPANDED_ACCESS

Enrollment

Not specified

Start Date

Not specified

Completion Date

Not specified

Last Updated

2026-07-23

Healthy Volunteers

No

Conditions

Interventions

DRUG

Metaiodobenzylguanidine (MIBG)

131I-MIBG Therapeutic Administration. Therapeutic 131I-MIBG will be synthesized at Jubilant DraxImage (Quebec, Canada) with specific activities of 9-18 Ci/mmole, or at Progenics with specific activity of 2,500 mCi/mg. The therapeutic dose (8-18 mCi/kg at investigator's discretion; any dose greater than 12 requires stored stem cells) will be diluted in 25-50 ml of normal saline for either preparation, and will be infused intravenously through a patient's central line, if already present, or a peripheral IV if a central line is not present.If Azedra is used, the dose will be infused over 30-60 minutes; the low specific activity preparation from Draximage will be infused over 90-120 minutes. For patients with pheochromocytoma or paraganglioma, the recommended maximum dose is 500 mCI or 12 mCi/kg.

Locations (1)

University of California, San Francisco

San Francisco, California, United States