drugset / Trial / NCT01183429

3F8/GM-CSF Immunotherapy Plus 13-Cis-Retinoic Acid for Consolidation of First Remission After Non-Myeloablative Therapy in Patients With High-Risk Neuroblastoma

NCT01183429

Phase 2 Completed 39 enrolled Memorial Sloan Kettering Cancer Center
NaSingle-groupOpen-labelTreatment

Summary

The purpose of this study is to find out what effects, good and/or bad, the combination of 3F8 and GM-CSF has on the patient and the cancer. Antibodies are made by the body to attack tumors and to fight infections. 3F8 is the name of one kind of antibody. It is made by mice, and it can attack neuroblastoma in people. 3F8 has been used safely in many patients, and it has killed cancer cells in some patients. One way it can kill cancer cells is by causing the patient's own white blood cells to attack the cancer. Granulocytes are one kind of white blood cell. GM-CSF increases the number of granulocytes in people, and it makes the granulocytes better able to kill the cancer cells.

Timeline

Start
2010-08-12
Primary completion
2018-09-13
Completion
2018-09-13

Drugs

EvaluationDrugModalityDoseRoute
Subject 3F8 Monoclonal antibody 20 mg/m2 Intravenous
Background Isotretinoin Other / unclassified 160 mg/m2

Indications