ANBL1821: A Phase 2 Randomized Study of Irinotecan/Temozolomide/Dinutuximab with or without Eflornithine (DFMO) (IND# 141913) in Children with Relapsed, Refractory or Progressive Neuroblastoma
The goal of this study is to utilize eflornithine (DFMO) to improve response rates in patients with relapsed neuroblastoma in combination with dinutuximab/irinotecan/temozolomide compared to patients assigned to receive dinutuximab/irinotecan/temozolomide alone. DFMO works to inhibit ODC1, an enzyme in the tumor growth pathway.
Are you Eligible? (Inclusion Criteria)
- Patients must be diagnosed with active relapsed, refractory or progressive disease.
- Patients must have histologic verification of neuroblastoma or ganglioneuroblastoma or demonstration of neuroblastoma cells in the bone marrow with elevated urinary catecholamines.
- Patients must be 1 year of age or older at the time of enrollment.
- Patients must also meet all eligibility criteria as outlined in the study protocol.