A Multicenter Phase 2/3 Trial of the Efficacy and Safety of Intracerebroventricular Radioimmunotherapy using 131I-burtomab for Neuroblastoma Central Nervous System/Leptomeningeal Metastases
The purpose of this research study is to find out about the treatment effects of an antibody called murine 8H9 (mu8H9).
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.
- IRB Number: 1801971637 (PHO-YMABS-PRADHAN-101)
- Research Study Identifier: TX8912
- Principal Investigator: Terry Vik, MD
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