New Treatment Approach Combining Chemotherapy and Anti-GD2 Antibody for Children Aged 18 Months to 18 Years With Stage 4 High-risk Neuroblastoma or Ganglioneuroblastoma

What this Trial Is About

Researchers are investigating new treatment options for children and adolescents aged 18 months to 18 years with stage 4 high-risk neuroblastoma or ganglioneuroblastoma. Current treatments show limited success in response rates and survival outcomes. This study aims to improve these results by combining standard chemotherapy with an immunotherapy drug called anti-GD2 monoclonal antibody dinutuximab beta during the initial phase of treatment. The study involves giving participants a combination of chemotherapy cycles labeled N5 and N6 alongside the anti-GD2 antibody. The N5 cycle includes vincristine, etoposide, cisplatin, and dinutuximab beta, while the N6 cycle combines vincristine, dacarbazine, ifosfamide, doxorubicin, and dinutuximab beta. Granulocyte colony-stimulating factor G-CSF is also administered to support blood cell recovery. Surgery, if needed, will be delayed until after the 4th or 6th induction cycle, and stem cell collection will occur between the 2nd and 5th cycles. The study focuses on the induction phase and does not analyze later consolidation treatments. Participants will be closely monitored for side effects and treatment tolerance using standardized criteria over three years. Researchers will assess overall response rates, survival, and event-free survival at specific time points after treatment completion. The study includes clinical evaluations, laboratory tests, imaging, and toxicity assessments. This comprehensive monitoring aims to understand the safety and potential improvements of this combined chemoimmunotherapy approach in high-risk neuroblastoma patients.

Induction Chemoimmunotherapy for Patients With High-risk Neuroblastoma