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

NCT01370330 · Status: AVAILABLE · Type: EXPANDED_ACCESS

Last updated 2025-07-22

No results posted yet for this study

Summary

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

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.

Sponsors & Collaborators

  • Cannonball Kids' Cancer Foundation

    collaborator OTHER

  • Kieuhoa Vo

    lead OTHER

Principal Investigators

  • Kieuhoa Vo, MD · University of California, San Francisco

Eligibility

Min Age
1 Year
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Countries

  • United States

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01370330 on ClinicalTrials.gov