Treatment Study for Children and Young Adults with High-Risk Neuroblastoma Using Intensified Chemotherapy, Stem Cell Rescue, Radiotherapy, and Immunotherapy

What this Trial Is About

Researchers are evaluating treatments for children and young adults with high-risk neuroblastoma, a type of cancer affecting nerve tissue. This trial involves patients with certain advanced stages of neuroblastoma, including those with specific genetic markers that indicate a higher risk of relapse. The goal is to assess different chemotherapy regimens, stem cell procedures, surgery, radiation, and immunotherapy combinations to improve outcomes such as event-free survival and metastatic response. The treatment plan includes an intensive chemotherapy induction phase called Rapid COJEC or a modified N7 regimen, followed by peripheral blood stem cell harvest and surgery to remove the primary tumor. Patients then receive myeloablative therapy with either busulfan plus melphalan or another chemotherapy combination, followed by stem cell rescue and radiotherapy. Immunotherapy involves the antibody ch14.18CHO given as a continuous infusion, with or without the immune stimulant Aldesleukin IL-2, alternating with isotretinoin. Some patients may receive additional chemotherapy cycles if needed, and treatment adaptations are made based on disease response and randomization results. Participants undergo regular assessments including evaluation of tumor response, event-free survival over up to three years, and metastatic response within about three months of induction therapy. Biological tumor markers and safety monitoring are also conducted. The study includes up to five years of follow-up to track long-term outcomes and monitor for disease progression or relapse. Treatments and evaluations are carefully scheduled to gather comprehensive data on the effectiveness and safety of these therapies in high-risk neuroblastoma.

High Risk Neuroblastoma Study 1.8 of SIOP-Europe (SIOPEN)