Study of Reduced Chemotherapy and Monoclonal Antibody Therapy for Children and Teens with High-Risk Neuroblastoma

What this Trial Is About

Researchers are evaluating whether a reduced chemotherapy regimen combined with monoclonal antibody mAb-based therapy, specifically using DANYELZA and Sargramostim, is safe and effective for children and teens with high-risk neuroblastoma. This Phase 2 study focuses on participants under 19 years old who have specific types of neuroblastoma, including those with MYCN amplification or advanced disease stages. The study aims to assess participant responses after treatment cycles. Participants will receive four cycles of induction chemotherapy involving drugs such as Cytoxan, Topotecan, Vincristine, Doxorubicin, Ifosfamide, Etoposide, Carboplatin, Irinotecan, and Temozolomide. After chemotherapy, a response-based intervention follows, which includes treatment with the monoclonal antibody DANYELZA and Sargramostim. Radiation therapy may be administered between the first and second cycles of antibody treatment. During the study, participants will be closely monitored for their response to treatment after two cycles of monoclonal antibody therapy, with each cycle lasting 21 days. Researchers will evaluate safety and effectiveness through clinical assessments and laboratory tests. The total participation period spans multiple treatment cycles, with ongoing evaluations to track health and response to therapy throughout the study.

N10: A Study of Reduced Chemotherapy and Monoclonal Antibody (mAb)-Based Therapy in Children With Neuroblastoma