drugset / Trial / NCT02332889

Phase I/II: Decitabine/Vaccine Therapy in Relapsed/Refractory Pediatric High Grade Gliomas/Medulloblastomas/CNS PNETs

NCT02332889

Phase 1/2 Terminated 1 enrolled University of Louisville
NaSingle-groupOpen-labelTreatment

Summary

The main purpose of this study is to determine the safety of using the combination of decitabine and a cancer vaccine plus Hiltonol. The vaccine will be made from the subject's blood cells and is designed to interact in the subject's body with cells that are programmed to fight specific tumor proteins NY-ESO-1, Melanoma Antigen Gene-A1 (MAGE-A1) and Melanoma Antigen Gene-A3 (MAGE-A3). The decitabine will be given to increase the amount and activity of these cancer proteins on the surface of tumor cells to increase the possibility that the vaccine will stimulate cells to act against the tumor cells. Subjects will be assessed to determine how these tumors respond to the treatment.

Timeline

Start
2015-04
Primary completion
2016-07
Completion
2016-07

Drugs

EvaluationDrugModalityDoseRoute
Subject Decitabine Small molecule 10 mg/m2 Intravenous
Subject Vaccine (autologous dendritic cells) Vaccine
Background Hiltonol Other / unclassified Intramuscular