Trial purpose
Cancer treatment
Tumor type
Brain and Spinal
Age
0 - 21
Clinical summary
Summary
This is a randomised 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 (R3 randomisation - Rapid COJEC vs modified N7), peripheral blood stem cell harvest, attempted complete excision of the primary tumour, myeloablative therapy (BuMel) followed by peripheral blood stem cell rescue, radiotherapy to the site of the primary tumour and immunotherapy (R4 randomisation - isotretinoin and ch14.18/CHO, with or without aldesleukin (IL-2). In the induction phase, all patients with stage 4 neuroblastoma and those with stage 4s MYCN-amplified neuroblastoma will be randomised (R3) to Rapid COJEC or modified N7; localised patients receive Rapid COJEC (Rapid COJEC is given with G-CSF support based on the results of the R0 randomisation running between 2002 and 2005). Following induction treatment peripheral blood stem cell harvest (PBSCH) will be performed and complete excision of the primary tumour will be attempted. Patients with an inadequate metastatic response to allow BuMel MAT followed by PBSCR at the end of induction should receive 2 TVD (Topotecan, Vincristine, Doxorubicin) cycles. After Rapid COJEC induction, localised patients will proceed to consolidation. Patients aged 12-18 months at diagnosis, with stage 4 neuroblastoma, no MYCN amplification and without segmental chromosomal alterations (SCA) are thought to have a good prognosis and will stop treatment after induction therapy and surgery to the primary tumour. Consolidation consists of BuMel MAT (following the results of the R1 randomisation) followed by peripheral blood stem cell rescue (PBSCR) and radiotherapy to the site of the primary tumour. During the immunotherapy phase, patients will be randomised (R4) to immunotherapy with isotretinoin (13-cis-RA) and ch14.18/CHO, with or without aldesleukin (IL-2).
Conditions
This trial is treating people with Neuroblastoma
Eligibility
Exclusion
Any negative answer concerning the inclusion criteria of the study
Exclusion
- You have certain types of non-cancer medical conditions.
- You have had certain treatments, surgical procedures or drugs.
Clinical trials have complex eligibility criteria, and other criteria may apply for this trial. Ask your doctor about whether this trial could be right for you.
More information
Trial Identifiers
Information on this page is partially produced from ClinicalTrials.gov *. View further details about this trial on the registry via the links below:
Trial sponsor
St. Anna Kinderkrebsforschung
Scientific Title
High Risk Neuroblastoma Study 1 of SIOP-Europe (SIOPEN)
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