Phase II Study of Chidamide, Dinutuximab Beta, Irinotecan, and Temozolomide to Treat Children with Relapsed or Refractory Neuroblastoma

What this Trial Is About

This trial is a Phase II study focusing on children diagnosed with relapsed or refractory neuroblastoma, a type of cancer that affects nerve tissue. Researchers are evaluating the safety and effectiveness of a combination of four drugs Chidamide, Dinutuximab Beta, Irinotecan, and Temozolomide. The goal is to understand how well this treatment controls the cancer and to observe any side effects in these young patients. The treatment involves Chidamide given orally at a dose of 5 mg per 10 kg body weight up to 30 mg twice weekly. It is taken on Days 0, 3, 7, and 10 in a three-week cycle, with two weeks on treatment followed by one week off. Chidamide is started one day before chemotherapy begins. This combination therapy is being studied as a potential option for children who have not responded adequately to previous treatments. Participants will be closely monitored from enrollment through 10 weeks of treatment. The study will assess the objective response rate, progression-free survival, event-free survival, duration of response, and overall survival during this period. Safety evaluations include monitoring side effects and laboratory tests to track bone marrow, kidney, liver, heart, and lung functions. Participants must comply with scheduled visits and assessments throughout the treatment phase.

Phase II Study of Chidamide-Dinutuximab Beta-Irinotecan-Temozolomide for Refractory/Relapsed Neuroblastoma in Children