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

Study Purpose

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

Recruitment Criteria

Accepts Healthy Volunteers

Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms

Study Type

An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes.

An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes.

Searching Both is inclusive of interventional and observational studies.

Eligible Ages N/A - 18 Years
Gender All
More Inclusion & Exclusion Criteria

Inclusion Criteria:

  • - 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 Criteria:

  • - 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.

Trial Details

Trial ID:

This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.


Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans.

Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data.

Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs.

Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.

Phase 2/Phase 3
Lead Sponsor

The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.

Y-mAbs Therapeutics
Principal Investigator

The person who is responsible for the scientific and technical direction of the entire clinical study.

Steen Lisby, MD
Principal Investigator Affiliation Y-mAbs Therapeutics
Agency Class

Category of organization(s) involved as sponsor (and collaborator) supporting the trial.

Overall Status Recruiting
Countries Denmark, Spain, United States

The disease, disorder, syndrome, illness, or injury that is being studied.

Neuroblastoma, CNS Metastases, Leptomeningeal Metastases
Additional Details

One 131I-omburtamab treatment cycle takes 5 weeks and includes a dosimetry dose, a treatment dose, an observation period and post-treatment evaluations.

  • - A dosimetry dose (2mCi) of 131I-omburtamab is administered during week 1 followed by blood/cerebral spinal fluid (CSF) samples and whole-body scintigraphy at predefined intervals during the following 48 hours after treatment.
  • - A therapeutic dose (50mCi) of 131I-omburtamab is administered during week 2 followed by a 3-week observation period that includes a repeated MRI, CSF cytology, and safety monitoring.
  • - A second treatment cycle of 131I-omburtamab is administered during week 6 if there is no objective disease progression week 5 after the first injection, and the participant is presenting without unexpected and clinical significant Grade 4 toxicity.
For participants with ongoing Grade 3 toxicity a second doing cycle will take place according to the discretion of the investigator. Participants can be treated in an outpatient setting or may be admitted as inpatients for both the dosimetry and the therapeutic injections. Participants completing at least one treatment period will first enter a follow-up period through week 26 and thereafter the long-term follow-up where patients will be evaluated for up to 3 years post-131I-omburtamab treatment where after the trial is ended Participants will be monitored for adverse events during and after 131I-omburtamab injection and will have pre- and post-treatment clinical assessments including neurologic examination, hematology and serum chemistry, blood and CSF cultures, endocrinology assessments, CSF analysis, and, pre- and post 131I-omburtamab performance testing. Performance testing will be performed at trial baseline, at week 26 and every 6 months during trial period.

Arms & Interventions


Experimental: 131I-omburtamab

One treatment cycle of 131I-omburtamab consists of 2 doses; 2mCi at week 1 and 50mCi at week 2). First cycle is initiated right after confirmation of eligibility at week 1. At week 6 the participant will be evaluated for safety and if eligible, receive a second cycle of 131I-omburtamab. Secondary efficacy endpoints will be evaluated at week 26 and primary efficacy endpoint will be evaluated at week 156.


Biological: - 131I-omburtamab

Murine IgG1 monoclonal antibody radiolabeled with iodine-131

Contact a Trial Team

If you are interested in learning more about this trial, find the trial site nearest to your location and contact the site coordinator via email or phone. We also strongly recommend that you consult with your healthcare provider about the trials that may interest you and refer to our terms of service below.

Childrens Hospital Los Angeles, Los Angeles, California


Not yet recruiting


Childrens Hospital Los Angeles

Los Angeles, California, 90027

University of Florida, Gainesville, Florida


Not yet recruiting


University of Florida

Gainesville, Florida, 32611

Riley Hospital for Children, Indianapolis, Indiana




Riley Hospital for Children

Indianapolis, Indiana, 46202

Memorial Sloan Kettering Cancer Center, New York, New York




Memorial Sloan Kettering Cancer Center

New York, New York, 10065

Nationwide Children's Hospital, Columbus, Ohio




Nationwide Children's Hospital

Columbus, Ohio, 43205

M.D. Anderson Cancer Center, Houston, Texas




M.D. Anderson Cancer Center

Houston, Texas, 77030

Site Contact

Douglas Harrison, MD



International Sites

Rigshospitalet, København, Denmark


Not yet recruiting



København, , 2100

Hospital Sant Joan de Déu, Barcelona, Spain




Hospital Sant Joan de Déu

Barcelona, , 08010

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