Neuroblastoma
Conditions
Interventions
Induction chemotherapy 1) 05A1: cyclophosphamide (CPA), vincristine (VCR), pirarubicin (THP), cisplatin (CDDP) 2) 05A3: CPA, VCR, THP, CDDP 3) 05A3: CPA, VCR, THP, CDDP 4) ICE: ifosphamide (IFO),
Sponsors
Japan Neuroblastoma Study Group (JNBSG)
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: (1) Age 180 days to 18 years old at study entry. (2) Histologically confirmed neuroblastoma or ganglioneuroblastoma by open biopsy of primary tumor or metastatic tumor, or by bone marrow biopsy. Patients can be registered before pathological diagnosis of primary tumor if high level of VMA/HVA and tumor cells in bone marrow were confirmed. (3) INRG classification high-risk cases with unresectable primary tumor at diagnosis. (4) No history of previous chemotherapy and/or radiotherapy, unless risk classification was changed (5) Patients must have sufficient organ function satisfying the laboratory data listed below 1. Lansky performance status score of 30 or higher 2. WBC 2000/mm3 or higher 3. ALT 300IU/L or lower; T.Bil 2.0mg/dL or lower 4. Serum creatinine level 0.8mg/dL or lower for patients younger than 5 years old 1.2mg/dL or lower for patients 5 to <10 years old 1.5mg/dL or lower for patients 10 to <18 years old 5. No heart disease which require any treatment (6) No active infection (7) All patients and/or their parents or legal guardians must sigh a written informed consent
Exclusion criteria
Exclusion criteria: (1) Patients with active coexistent malignant neoplasms (2) Patients who are pregnant or breastfeeding mother (3) Patients with mental disorder who is considered inappropriate for study participation (4) Patients with any other inappropriate condition judged by physician
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Complete remission rate at the end of the protocol therapy | — |
Secondary
| Measure | Time frame |
|---|---|
| 1) Rate of adverse events during the protocol therapy 2) Completion rate of the protocol therapy 3) Clinical response rate before autologous hematopoietic stem cell transplantation 4) Clinical response rate after autologous hematopoietic stem cell transplantation (but before surgical resection) 5) Clinical response rate after completion of the protocol therapy (including surgical resection and radiotherapy) 6) Completion rate of induction chemotherapy 7) Number of harvested autologous hematopoietic stem cells 8) Evaluation of MIBG scintigraphy before high-dose therapy and after radiotherapy | — |
Countries
Japan
Contacts
Public ContactKimikazu Matsumoto
National Center for Child Health and Development Children's Cancer Center
Outcome results
None listed