drugset
drugset / Trial / NCT00659984

N2007-01: Ultratrace™ Iobenguane I 131 in Patients With Relapsed/Refractory High-Risk Neuroblastoma

NCT00659984 ↗

Phase 2 Completed 15 enrolled Molecular Insight Pharmaceuticals, Inc.
NaSingle-groupOpen-labelTreatment

Summary

RATIONALE: Radioactive drugs, such as iodine I 131 metaiodobenzylguanidine (MIBG), may carry radiation directly to tumor cells and not harm normal cells. A bone marrow or peripheral stem cell transplant using stem cells from the patient may be able to replace blood-forming cells that were destroyed by I 131 MIBG. PURPOSE: This phase II trial is studying the side effects and best dose of iodine I 131 MIBG followed by a stem cell transplant in treating young patients with relapsed or refractory high-risk neuroblastoma.

Timeline

Start
2008-06
Primary completion
2010-08
Completion
2010-11

Drugs

EvaluationDrugModalityDoseRoute
Subject UltratraceTM Iobenguane I 131 Other / unclassified 3.7 mbq/kg Intravenous
Subject UltratraceTM Iobenguane I 131 Other / unclassified 414.4 mbq/kg Intravenous
Subject UltratraceTM Iobenguane I 131 Other / unclassified 573.5 mbq/kg Intravenous
Subject UltratraceTM Iobenguane I 131 Other / unclassified 673.4 mbq/kg Intravenous

Indications

neuroblastoma