A Multicenter Phase 2/3 Trial of the Efficacy and Safety of Intracerebroventricular Radioimmunotherapy using 131I-burtomab for Neuroblastoma Central Nervous System/Leptomeningeal Metastases

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Updated on 19 February 2024

Summary

The purpose of this research study is to find out about the treatment effects of an antibody called murine 8H9 (mu8H9).

Description

The proposed phase 2/3 international multi-center trial evaluates the efficacy and safety of intracerebroventricular 131I-burtomab as well as the dosimetry in pediatric NB patients with CNS/LM metastases. The findings of the proposed trial will expand and be compared with the findings of the single center trial of intracerebroventricular 131I-burtomab in pediatric patients with NB CNS/LM metastases treated in the MSK Trial 03-133. The aggregate findings from the two trials evaluating patients from several centers in the US as well as Europe seek to provide a basis for establishing 131I-burtomab as the next generation treatment of NB patients with CNS/LM metastases.

Details
Condition Leptomeningeal Metastases,CNS Metastases,Neuroblastoma
Age 18years or below
Clinical Study IdentifierTX8912
Last Modified on19 February 2024

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