drugset / Trial / NCT00874861

HLA-A2-Restricted Glioma Antigen-Peptides Vaccinations With Poly-ICLC for Recurrent WHO Grade II Gliomas

NCT00874861

NaSingle-groupOpen-labelTreatment

Summary

This is a pilot vaccine study in adults with recurrent WHO Grade II gliomas. The purpose of this study is to test the safety and efficacy of an experimental tumor vaccine made from peptides in combination with the study drug Poly-ICLC. Poly-ICLC, manufactured by Oncovir, Inc., has already been received and is generally well tolerated by subjects in earlier studies and has been shown to decrease the size of brain tumors in some cases. The immunological and safety data will be used to decide whether a larger study of clinical efficacy is warranted.

Timeline

Start
2009-04
Primary completion
2012-05
Completion
2013-11

Drugs

EvaluationDrugModalityDoseRoute
Subject NY-ESO-1 Protein / enzyme biologic Subcutaneous
Background Hiltonol Other / unclassified 20 mg/kg Intramuscular