High Risk Neuroblastoma Study 1.8 of SIOP-Europe (SIOPEN)
This is a randomized study of the European SIOP Neuroblastoma Group (SIOPEN) in high-risk neuroblastoma (stages 2, 3, 4 and 4s MYCN-amplified neuroblastoma, stage 4 MYCN non amplified \> 12 months at diagnosis). The protocol consists of a rapid, dose intensive induction chemotherapy, peripheral blood stem cell harvest,
| Condition(s) | Neuroblastoma |
|---|---|
| Status | Recruiting |
| Phase | Phase 3 |
| Study type | Interventional |
| Summary | This is a randomized study of the European SIOP Neuroblastoma Group (SIOPEN) in high-risk neuroblastoma (stages 2, 3, 4 and 4s MYCN-amplified neuroblastoma, stage 4 MYCN non amplified \> 12 months at diagnosis). The protocol consists of a rapid, dose intensive induction chemotherapy, peripheral blood stem cell harvest, attempted complete excision of the primary tumour, myeloablative therapy followed by peripheral blood stem cell rescue, radiotherapy to the site of the primary tumour and immunotherapy (R4 randomization - isotretinoin and ch14.18/CHO (Dinutuximab beta, Qarziba ®).), with or without s.c. aldesleukin (IL-2)). Patients diagnosed after the closure of R3 randomization will not be R4 randomized. For these patients the use of ch14.18/CHO antibody is recommended without scIL-2 as co |
| Who can participate | Inclusion Criteria: * • Established diagnosis of neuroblastoma according to the International Neuroblastoma Staging System (INSS). * Age below 21 years. * High risk neuroblastoma defined as either: 1. INSS stage 2, 3, 4, and 4s with MYCN amplification, or 2. INSS stage 4 without MYCN amplification aged \> 12 months at diagnosis * Patients who have received no previous chemotherapy except for one cycle of etoposide and carboplatin (VP16/Carbo). In this situation patients will receive Rapid COJEC induction and the first Rapid COJEC cycle may be replaced by the first cycle VP16/Carbo (etoposide / carboplatin). * Written informed consent, including agreement of parents or legal guardian for minors, to enter a randomised study if the criteria for randomisation are met. * Tumour cell material av |
| Ages | 1 Month to 21 Years |
| Sex | All |
| Lead sponsor | St. Anna Kinderkrebsforschung |
| Locations | Adelaide, Australia; Brisbane, Australia; Newcastle, Australia; Parkville, Australia; Sydney, Australia; Westmead, Australia (+120 more sites) |
| Start date | 2002-02 |
| NCT ID | NCT01704716 |
| Official listing | https://clinicaltrials.gov/study/NCT01704716 |