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

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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
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Who can take part

You may be eligible to participate in the study if you meet the following criteria:

INCLUSION CRITERIA

Inclusion Criteria:


  1. Patients must have a histologically confirmed diagnosis of neuroblastoma with relapse in the central nervous system or in the meninges (leptomeningeal).
  2. Patients must be between the ages of birth and 18 years at the time of screening.
  3. Patients must have a life expectancy of at least 3 months.

EXCLUSION CRITERIA

Exclusion Criteria:


  1. Patients with primary neuroblastoma in central nervous system.
  2. Patients must not have an uncontrolled life-threatening infection.
  3. Patients must not have received cranial or spinal irradiation less than 3 weeks prior to first dose of 131I-omburtamab in this trial.
  4. Patients must not have received systemic chemotherapy (corticosteroids not included) less than 3 weeks prior to enrollment in this trial.
  5. 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.

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Study Locations

Enter your ZIP code/Postal code/PIN code to locate study sites near you:

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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