About the Study

High-Risk Neuroblastoma (NBL): A study of immunotherapy with or without DFMO after molecular therapy and induction chemotherapy in newly diagnosed patients

In this study the team is testing the effectiveness of adding an experimental agent called DFMO to the standard immunotherapy for high-risk neuroblastoma. This portion of the study will be a randomized trial (like flipping a coin). The study team will use a computer system to randomly decide which group each study participant will be placed in. The participant's physicians will not be able to help decide which group they will be placed in. Half of subjects, Group A, will receive standard immunotherapy with Dinutuximab, GM-CSF, and Isotretinoin. The other half of subjects, Group B, will receive standard immunotherapy with Dinutuximab, GM-CSF, Isotretinoin in combination with the study drug DFMO. The study team cannot guarantee which group each participant will be placed in. At the end of the 6 cycles of immunotherapy, all patients (both Arm A and Arm B) will receive DFMO twice a day for 730 days as maintenance therapy.

Interested in learning more?

Full Study Name: NMTRC012 PEDS-PLAN - Pediatric Precision Laboratory Advanced Neuroblastoma Therapy A Study Using Molecular Guided Therapy with Induction Chemotherapy followed by a Randomized Controlled Trial of standard immunotherapy with or without DFMO followed by DFMO maintenance for Subjects with Newly Diagnosed High-Risk Neuroblastoma