Trial Identifiers
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Scientific Title
A Phase 2 Randomized Study of Irinotecan/Temozolomide/Dinutuximab With or Without Eflornithine (DFMO) in Children With Relapsed, Refractory or Progressive Neuroblastoma
Cooperative Group
Children's Oncology Group
Other Non-Commercial Sponsor
National Cancer Institute (NCI)
Summary
ELigible patients will be randomised to 1 of 2 regimens.
In Regimen A, patients receive temozolomide orally, via nasogastric, or gastric tube on days 1-5, irinotecan hydrochloride intravenously over 90 minutes on days 1-5, dinutuximab IV over 10-20 hours on days 2-5, and sargramostim subcutaneously or intravenously over 2 hours on days 6-12 of a 21-day cycle. Treatment in this regimen will be repeated every 21 days for up to 17 cycles in the absence of disease progression or unacceptable toxicity. In Regimen B, patients will receive eflornithine orally, via nasogastric, or gastric tube on days -6 to 7 and days 15-21 of cycle 1 orally, via nasogastric, or gastric tube on days 1-5, irinotecan hydrochloride intravenously over 90 minutes on days 1-5, dinutuximab intravenously over 10-20 hours on days 2-5, and sargramostim subcutaneously or intravenously over 2 hours on days 6-12. Treatment in this regimen will last for 28 days for cycle 1 and then every 21 days for subsequent cycles. Up to 17 cycles will be administered in the absence of disease progression or unacceptable toxicity. After completion of study treatment, patients are followed up at 30 days and periodically for 5 years.