Status:
TERMINATED
131I-omburtamab Radioimmunotherapy for Neuroblastoma Central Nervous System/Leptomeningeal Metastases
Lead Sponsor:
Y-mAbs Therapeutics
Conditions:
Neuroblastoma
CNS Metastases
Eligibility:
All Genders
Up to 18 years
Phase:
PHASE2
PHASE3
Brief Summary
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 anti...
Detailed Description
One 131I-omburtamab treatment cycle takes 4 weeks and includes a treatment dose, and an observation period and post-treatment evaluations. One 131I-omburtamab treatment cycle for Japan only takes 5 w...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
December 11 2018
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 2 2023
Estimated Enrollment :
52 Patients enrolled
Trial Details
Trial ID
NCT03275402
Start Date
December 11 2018
End Date
June 2 2023
Last Update
February 13 2024
Active Locations (8)
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1
Childrens Hospital Los Angeles
Los Angeles, California, United States, 90027
2
Riley Hospital for Children
Indianapolis, Indiana, United States, 46202
3
Memorial Sloan Kettering Cancer Center
New York, New York, United States, 10065
4
Nationwide Children's Hospital
Columbus, Ohio, United States, 43205