131I-omburtamab Radioimmunotherapy for Neuroblastoma Central Nervous System/Leptomeningeal Metastases
About the study
Children with a neuroblastoma diagnose and central nervous system (CNS)/leptomeningeal metastases will be given up to 2 rounds of intracerebroventricular treatment with a radiolabelled monoclonal antibody, 131I-omburtamab to evaluate efficacy and safety
Who can take part
You may be eligible to participate in the study if you meet the following criteria:
INCLUSION CRITERIA
Inclusion Criteria:
- Patients must have a histologically confirmed diagnosis of neuroblastoma with relapse in the central nervous system or in the meninges (leptomeningeal).
- Patients must be between the ages of birth and 18 years at the time of screening.
- Patients must have a life expectancy of at least 3 months.
EXCLUSION CRITERIA
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.
Study Locations
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How to Apply
Contact the study center to learn if this study is a good match for you.
Study’s details
Contition
Neuroblastoma,CNS Metastases,Leptomeningeal Metastases
Age (in years)
< 18
Phase
Phase 2/Phase 3
Participants needed
52
Est. Completion Date
Dec 31, 2026
Treatment type
Interventional
Sponsor
Y-mAbs Therapeutics
ClinicalTrials.gov identifier
NCT03275402
Study number
101
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