Glioma Clinical Trial
Official title:
A Bi-Institutional Pilot Study to Evaluate the Effects of Vaccinations With HLA-A2-Restricted Glioma Antigen-Peptides in Combination With Poly-ICLC for Adults With WHO Grade II Low-Grade Gliomas
This is a pilot vaccine study in adults with either WHO grade II astrocytoma,
oligoastrocytoma or oligodendroglioma. The purpose of this study is test the safety and
efficacy of an experimental tumor vaccine made from peptides and Montanide ISA-51 in
combination with the study drug Poly-ICLC.
Poly-ICLC, manufactured by Oncovir, Inc., has already been received and 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 in each of two patient cohorts.
All patients on the study will be followed for a minimum of 2 years, so that the actual 2-year overall survival (OS) and progression-free survival (PFS) rates can be determined in an exploratory manner. ;
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