Dinutuximab-beta and Chemotherapy in Newly Diagnosed High-Risk Neuroblastoma
Summary
This clinical trial investigates the safety, side effects, and effectiveness of combining an immunotherapy drug called dinutuximab-beta with standard induction chemotherapy for patients newly diagnosed with high-risk neuroblastoma. Dinutuximab-beta is an antibody designed to target specific molecules on the surface of neuroblastoma cells. In this pilot study, enrolled patients will receive dinutuximab-beta as a continuous intravenous infusion alongside a standard 6-cycle induction chemotherapy regimen. The primary goals of this study are to monitor how well patients tolerate the new combination treatment closely and to determine how effectively tumors shrink before patients proceed to the next phase of their standard consolidation therapy.
Timeline
- Start
- 2026-07-01
- Primary completion
- 2032-12-31
- Completion
- 2032-12-31
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Dinutuximab | Monoclonal antibody | 10 mg/m2 | Intravenous |
| Background | Cisplatin | Other / unclassified | — | — |
| Background | Cyclophosphamide | Other / unclassified | — | — |
| Background | Doxorubicin | Other / unclassified | — | — |
| Background | Epirubicin | Small molecule | — | — |
| Background | Etoposide | Small molecule | — | — |
| Background | Vincristine | Small molecule | — | — |