Summary

Eligibility
for people ages 1 year and up (full criteria)
Location
at UC Davis UCSF
Dates
study started
completion around

Description

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.

Official Title

A Phase 2 Randomized Study of Irinotecan/Temozolomide/Dinutuximab With or Without Eflornithine (DFMO) in Children With Relapsed, Refractory or Progressive Neuroblastoma

Details

Keywords

High Risk Neuroblastoma, Recurrent Neuroblastoma, Refractory Neuroblastoma, Neuroblastoma, Eflornithine, Irinotecan, Camptothecin, Temozolomide, Dinutuximab, Sargramostim, Monoclonal Antibodies, Eflornithine Hydrochloride, Irinotecan Hydrochloride, chemotherapy, dinutuximab, sargramostim, eflornithine, chemotherapy, dinutuximab

Eligibility

Locations

Details

Status
in progress, not accepting new patients
Start Date
Completion Date
(estimated)
Sponsor
Children's Oncology Group
ID
NCT03794349
Phase
Phase 2 Neuroblastoma Research Study
Study Type
Interventional
Participants
Expecting 95 study participants
Last Updated