high risk neuroblastoma
Conditions
Interventions
G therapy: Six courses of G therapy CSF regimen and G therapy IL2 regimen alternately. 1. G therapy CSF regimen Subcutaneous injection of filgrastim 5 mcrg / kg from day 1 to day 14. Intravenous a
12 kg) or 5.33 mg/kg (BW <
=12 kg) isotretionoin from day 11 to day 24 2. US IL2 regimen Intravenous administration of aldesleukin 300 MU / m2 from day 1 to day 4 and from day 8 to day 11 Intravenous administration of dinutu
=12 kg) isotretionoin from day 11 to day 24 3. Isotretinoin regimen Orally 160 mg/m2 (BW >
=12 kg) isotretionoin from day 11 to day 24
Sponsors
Osaka City General Hospital
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. All patients must have completed therapy including intensive induction followed by ASCT and radiotherapy. 2. No more than 12 months from the date of starting the first induction chemotherapy after diagnosis to the date of ASCT. 3. At pre-ASCT evaluation patients must meet the INRC for CR, VGPR, or PR for any region. 4. For those with residual disease after operation, re-evaluation of irradiated residual tumors is performed at the earliest 5 days after completing radiotherapy. 5. <= 10% tumor seen on any specimen from a bone marrow aspirate/biopsy. 6. Patients must be enrolled no later than Day 100 after PBSC infusion. However, in the cases with surgery followed by autologous peripheral blood transfusion, allowing less than 150 days from autologous peripheral blood stem cell infusion. 7. Patients must not have received prior anti-GD2 antibody therapy. 8. Patients must have a Lansky or Karnofsky Performance Scale score of >= 50%. 9. Patient must have adequate organ function.
Exclusion criteria
Exclusion criteria: 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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Two-year event free survival | — |
Secondary
| Measure | Time frame |
|---|---|
| 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 | — |
Countries
Japan
Contacts
Public ContactChika Nitani
Osaka City General Hospital Department of Pediatric Hematology/Oncology
Outcome results
None listed