This is a phase II study looking at patient response to treatment with the combination dinutuximab, temozolomide, irinotecan, and GM-CSF.
Patients must be ≥ 1 year and ≤31 years of age at the time of enrollment on the study.
Patients must have a diagnosis of neuroblastoma either by histologic verification of neuroblastoma and/or demonstration of tumor cells in the bone marrow with increased urinary catecholamines.
Patients must have high-risk neuroblastoma according to COG risk classification at the time of study registration. Patients whose disease was initially considered low or intermediate risk but then reclassified as high-risk neuroblastoma prior to enrollment also meet this criteria.
SIZE: Lesion can be accurately measured in at least one dimension with a longest diameter ≥ 10 mm, or for discrete lymph nodes ≥ 15mm on short axis. Lesions meeting size criteria will be considered measurable.
Patients who are pregnant, breast feeding, or unwilling to use effective contraception during the study
Patients who, in the opinion of the investigator, may not be able to comply with the safety monitoring requirements of the study.
Patients with disease of any major organ system that would compromise their ability to withstand therapy.
Patients with > Grade 2 diarrhea.
New Approaches to Neuroblastoma Therapy Consortium
Lead sponsor
Nationwide Children's Hospital
Collaborator
United Therapeutics
Collaborator
Children's Neuroblastoma Cancer Fund
Collaborator