At a glance
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A Phase 2 Randomized Study of Irinotecan/Temozolomide/Dinutuximab With or Without Eflornithine (DFMO) in Children With Relapsed, Refractory or Progressive Neuroblastoma
In Brief
A Phase 2 clinical trial evaluating Dinutuximab, Eflornithine Hydrochloride, and 3 other interventions for High Risk Neuroblastoma and 2 related conditions. Active but no longer recruiting, targeting 94 participants across 145 sites in 5 countries.
Detailed Summary
This phase II trial studies how well irinotecan hydrochloride, temozolomide, and dinutuximab work with or without eflornithine in treating patients with neuroblastoma that has come back (relapsed) or that isn't responding to treatment (refractory). Drugs used in chemotherapy, such as irinotecan hydrochloride and temozolomide, work in different ways to stop the growth of tumor cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Immunotherapy with monoclonal antibodies, such as dinutuximab, may induce changes in the body's immune system and may interfere with the ability of tumor cells to grow and spread. Eflornithine blocks the production of chemicals called polyamines that are important in the growth of cancer cells. Giving eflornithine with irinotecan hydrochloride, temozolomide, and dinutuximab, may work better in treating patients with relapsed or refractory neuroblastoma.
Study Details
Timeline
Interventions
Given IV
Given PO or via NG or G tube
Given IV
Given SC or IV
Given PO or via NG or G tube