Phase 3 Study of Adding Dinutuximab to Intensive Multimodal Therapy Including Chemotherapy, Surgery, Stem Cell Transplantation, and Radiation for Children with Newly Diagnosed High-Risk Neuroblastoma

What this Trial Is About

Researchers are evaluating the addition of dinutuximab to standard treatments for children with newly diagnosed high-risk neuroblastoma, a type of cancer that affects nerve tissue. This phase III trial compares standard chemotherapy and surgery to chemoimmunotherapy, which combines chemotherapy with dinutuximab, an antibody aimed at helping the immune system target cancer cells. The study also explores how these treatments affect survival, response rates, side effects, tumor markers, and quality of life. Participants receive multiple cycles of induction chemotherapy with drugs like cyclophosphamide, topotecan, cisplatin, etoposide, vincristine, and doxorubicin. They are randomly assigned to either standard chemotherapy alone or chemotherapy combined with dinutuximab. After initial treatment cycles, tumor response is assessed to guide further therapy patients with good responses proceed to high-dose chemotherapy with stem cell transplants and radiation, followed by post-consolidation immunotherapy with dinutuximab and isotretinoin. Those with poor responses receive additional chemoimmunotherapy during an extended induction phase. Throughout the study, participants undergo blood and urine tests, heart scans, bone marrow biopsies, and various imaging scans including CT, MRI, and specialized PET scans. The research team monitors treatment effects, tumor markers, and quality of life over time. After completing treatment, patients are followed regularly for up to 10 years to assess long-term outcomes and side effects, with the main goal of measuring event-free survival up to three years.

Dinutuximab With Chemotherapy, Surgery and Stem Cell Transplantation for the Treatment of Children With Newly Diagnosed High Risk Neuroblastoma