drugset / Trial / NCT01041638

Monoclonal Antibody Ch14.18, Sargramostim, Aldesleukin, and Isotretinoin After Autologous Stem Cell Transplant in Treating Patients With Neuroblastoma

NCT01041638

Phase 3 Completed 105 enrolled National Cancer Institute (NCI)
NaSingle-groupOpen-labelTreatment

Summary

This phase III trial is studying the side effects of giving monoclonal antibody Ch14.18 together with sargramostim, aldesleukin, and isotretinoin after autologous stem cell transplant in treating patients with neuroblastoma. Monoclonal antibodies, such as Ch14.18, may find tumor cells and help kill them. Colony-stimulating factors, such as sargramostim, may increase the number of immune cells found in bone marrow or peripheral blood. Aldesleukin may stimulate the white blood cells to kill tumor cells. Isotretinoin may help neuroblastoma cells become more like normal cells, and to grow and spread more slowly. Giving monoclonal antibody Ch14.18 with sargramostim, aldesleukin, and isotretinoin after autologous stem cell transplant may be an effective treatment for neuroblastoma.

Timeline

Start
2009-12-21
Primary completion
2013-12-31
Completion
2021-06-30

Drugs

EvaluationDrugModalityDoseRoute
Subject Dinutuximab Monoclonal antibody Intravenous
Subject Isotretinoin Other / unclassified Oral
Subject aldesleukin Protein / enzyme biologic Intravenous
Subject sargramostim Protein / enzyme biologic Intravenous

Indications