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

Contact:

NCT Number:

Protocol:

AAAS5155

Study Status:

Active/Enrolling

Population:

Pediatrics

Phase:

II

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.

Specialty Area(s)

Childhood and Adolescent Cancers (Pediatric), Pediatric: Solid Tumors

Principal Investigator

Trial Location(s)

CUIMC/Herbert Irving Pavilion
161 Fort Washington Avenue
New York, NY 10032