ANBL19P1: A Pilot Study of Dinutuximab Sargramostim (GM-CSF) and Isotretinoin in Combination with Irinotecan and Temozolomide in the Post-Consolidation Setting for High-Risk Neuroblastoma

Brief description of study

The overall goal of this study is to find out whether the combination of the chemotherapy drugs temozolomide and irinotecan with immunotherapy can be given safely to people with high-risk neuroblastoma (NBL) when given following Consolidation therapy. The treatment involves cancer fighting medicine called chemotherapy plus dinutuximab, sargramostim (GM-CSF), and isotretinoin. Dinutuximab, GM-CSF and isotretinoin have been given following high dose chemotherapy with stem cell transplant as part of standard treatment for high-risk NBL therapy for more than 10 years. During this study, the chemotherapy drugs irinotecan and temozolomide are being added to dinutuximab, GM-CSF and isotretinoin. The treatment on this study takes about 6 months. It is divided into 6 cycles of therapy.

Chemotherapy drugs, such as irinotecan 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. They may also effect how well immunotherapy works on neuroblastoma cells. We want to know if giving chemo-immunotherapy after intensive therapy may work better in treating patients with high-risk neuroblastoma compared to standard immunotherapy.

Clinical Study Identifier: s21-00485 Identifier: NCT04385277

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