131I-omburtamab Radioimmunotherapy for Neuroblastoma Central Nervous System/Leptomeningeal Metastases

Stopped early · Phase 2/Phase 3

Conditions studied: Neuroblastoma, CNS Metastases, Leptomeningeal Metastases

In brief

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

Key facts

Study ID

NCT03275402

Run by

Y-mAbs Therapeutics

People needed

52

Starts

2018-12-11

Expected to finish

2023-06-02

Last updated by the study team

2024-02-13

Who can join

Age: any, up to 18. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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.

Where it is running

• Childrens Hospital Los Angeles — Los Angeles, California, United States
• Riley Hospital for Children — Indianapolis, Indiana, United States
• Memorial Sloan Kettering Cancer Center — New York, New York, United States
• Nationwide Children's Hospital — Columbus, Ohio, United States
• M.D. Anderson Cancer Center — Houston, Texas, United States
• Rigshospitalet — Copenhagen, Denmark
• Department of Pediatric Oncology Fukushima Medical University Hospita — Fukushima, Japan
• Hospital Sant Joan de Déu — Barcelona, Spain

Full record on ClinicalTrials.gov

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