Clinical Trial · NCT03275402

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

Overview

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

Sponsor

Y-mAbs Therapeutics, Inc.

Phase

Phase 2/3

Contacts

John Roemer, MD (STUDY_DIRECTOR)

ClinicalTrials.gov

NCT03275402

Eligibility

Inclusion

Patients must have a life expectancy of at least 3 months.
* 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.

Exclusion

Patients must not have an uncontrolled life-threatening infection.
* Patients with primary neuroblastoma in central nervous system.
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.