XCancer

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

Description:

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)

Government Study Link:

NCT03275402 - Click here to see study on

ClinicalTrials.gov

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.