131I-omburtamab Radioimmunotherapy for Neuroblastoma Central Nervous System/Leptomeningeal Metastases
- Conditions
- euroblastoma
- Registration Number
- JPRN-jRCT2021200024
- Lead Sponsor
- Tomita Koji
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- 5
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.
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.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method 1. Overall survival rate at 3 years after the first treatment dose of 131I-omburtamab.
- Secondary Outcome Measures
Name Time Method