Phase 2b study of combined immunotherapy with dinutuximab, interleukin-2, and G-CSF for high risk neuroblastoma
- Conditions
- high risk neuroblastoma
- Registration Number
- JPRN-UMIN000023009
- Lead Sponsor
- Osaka City General Hospital
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Complete: follow-up complete
- Sex
- All
- Target Recruitment
- 35
Not provided
1. Synchronous or asynchronous (within 5 years) other cancer except carcinoma in situ or intramucosal carcinoma. 2. Active infection requires systemic therapy. 3. Epileptic seizures without control by anticonvulsants 4. Daily use of a steroid 5. Administration of immune globulin within 28 days 6. Abnormalities of ECG requires therapy. 7. Less than 30% of Fractional Shortening and less than 55% of Ejection Fraction in cardiac function within 28 days There is respiratory failure requiring 8. oxygen administration 9. Woman during pregnancy, or impossible to discontinue breast-feeding for 120 days after the final dose of study treatment. 10. Patient or the partner without intent to use birth control. 11. Inadequate physical condition judged by investigator. 12. Known investigational drugs allergy.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Two-year event free survival
- Secondary Outcome Measures
Name Time Method 1. Overall-survival, response rate and progression-free survival 2. Adverse event of G therapy and US regimen 3. ADCC activity in G therapy and US regimen 4. Production rate of human anti-chimeric antibody (HACA) 5. Pharmacokinetics of isotretinoin