Spots Global Cancer Trial Database for Combination Chemotherapy Followed by Stem Cell Transplant in High-risk Neuroblastoma Patients

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Trial Identification

Brief Title: Combination Chemotherapy Followed by Stem Cell Transplant in High-risk Neuroblastoma Patients

Official Title: Combination Chemotherapy Followed by Stem Cell Transplant and Isotretinoin in Treating Young Patients With High-risk Neuroblastoma

Study ID: NCT03042429

Conditions

Neuroblastoma

Interventions

Cycles N8, N5 and N6

Cycles N5 and N6

Study Description

Brief Summary: Improvement of event free survival of high-risk neuroblastoma patients by introduction of two additional topotecan containing chemotherapy cycles into the multimodal standard treatment (induction chemotherapy, myeloablative therapy, radiation, surgery as indicated, and consolidation therapy).

Detailed Description: Experimental intervention (6 weeks + duration of the control intervention): 2 x N8 cycle (topotecan, cyclophosphamide, and etoposide) followed by standard arm treatment (i.e., control intervention) Control intervention (total duration 70-76 weeks): 3 x N5 cycle (cisplatin, etoposide, and vindesine) 3 x N6 cycle (vincristine, dacarbacine, ifosfamide, and doxorubicine), myeloablative chemotherapy with autologous stem cell transplantation (melphalan, carboplatin, etoposide) 9 x retinoic acid cycles (6 months, 3 months break, 3 months) supportive care (PCP/fungal prophylaxis, transfusions, antibiotics, G-CSF)