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
Additional locations may be listed on ClinicalTrials.gov for NCT03275402.
See trial information on ClinicalTrials.gov for a list of participating sites.
One 131I-omburtamab treatment cycle takes 4 weeks and includes a treatment dose, and an
observation period and post-treatment evaluations.
One 131I-omburtamab treatment cycle for Japan only takes 5 weeks and includes 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 1 (week 2
for Japan) 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 5 (week 6
for Japan) 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.
In case the patient has a subsequent relapse in the CNS/LM after 131I-omburtamab therapy
during the follow-up period, re-treatment to target minimal residual disease can be
considered and allowed.
Lead OrganizationY-mAbs Therapeutics
