A Phase 3 Study of Dinutuximab Added to Intensive Multimodal Therapy for Children With Newly Diagnosed High-Risk Neuroblastoma
Categories (click each to see list of all clinical trials associated with that category): Pediatric (PEDONC)
Current Status: Open
Phase: III (Cancer Control)
Principal Investigator: Beck, Jill
Eligibility: https://clinicaltrials.gov/study/NCT06172296?term=NCT06172296&rank=1#participation-criteria
Summary
PRIMARY OBJECTIVE:
I. To determine if the event-free survival (EFS) of patients with newly diagnosed high-risk neuroblastoma assigned to early chemoimmunotherapy during Induction differs from that of patients who are not assigned to treatment that includes early chemoimmunotherapy.
SECONDARY OBJECTIVES:
I. To determine if early chemoimmunotherapy during Induction therapy improves end of induction (EOI) response rates and overall survival (OS) for patients with newly diagnosed high-risk neuroblastoma.
II. To determine response rates, EFS, and OS following an extended induction regimen with chemoimmunotherapy in patients with progressive disease or a poor response to Induction therapy.
III. To compare the toxicities experienced by patients treated with chemoimmunotherapy during induction versus those experienced by patients treated with standard induction and to describe toxicities experienced during extended induction.
IV. To determine GD2 expression on tumor tissue and tumor cells in bone marrow and assess for associations with response and outcome.