A Multicenter Phase 2/3 Trial of the Efficacy and Safety of Intracerebroventricular Radioimmunotherapy using 131I-burtomab for Neuroblastoma Central Nervous System/Leptomeningeal Metastases
Terry Vik, MD
Primary Investigator
Overview
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.
Eligibility
You may be eligible for this study if you meet the following criteria:
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Conditions:
Neuroblastoma, CNS Metastases, Leptomeningeal Metastases
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Age: - 18 Years
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Gender: All
Inclusion Criteria
Patients must have a histologically confirmed diagnosis of neuroblastoma with relapse in the central nervous system or in the meninges (leptomeningeal)
Exclusion Criteria
Patients with primary neuroblastoma in central nervous system
Patients must not have an uncontrolled life-threatening infection
Patients must not have received cranial or spinal irradiation less than 3 weeks prior to first dose of 131I-omburtamab in this trial
Patients must not have received systemic chemotherapy (corticosteroids not included) less than 3 weeks prior to enrollment in this trial
Patients must not have severe major non-hematologic organ toxicity; specifically, any renal, cardiac, hepatic, pulmonary, and gastrointestinal system toxicity must fall below Grade 3 prior to enrollment in this trial. Patients with stable neurological deficits (due to brain tumor) are not excluded. Patients with Grade 3 or lower hearing loss are not excluded.
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