Astrocytoma Clinical Trial
Official title:
A Pilot Study to Evaluate the Effects of Vaccinations With HLA-A2-Restricted Glioma Antigen-Peptides in Combination With Poly-ICLC for Adults With Recurrent WHO Grade II Gliomas
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.
This is a pilot study of a vaccination regime that is designed to efficiently induce
anti-tumor T-cell responses in patients with recurrent WHO grade II glioma. The proposed
regime combines subcutaneous injections of glioma-associated antigen (GAA)-derived cytotoxic
T-lymphocyte (CTL) epitope-peptides with simultaneous intramuscular (i.m.) administration of
poly-ICLC.
The overall objective of this pilot study is to collect immunological and safety data that
will be used to decide whether a larger study of clinical efficacy is warranted in these
patients. All patients on the study will be followed for a minimum of 2 years, so that the
actual 2-year overall survival (OS), 6-month and 2-year progression-free survival (PFS)
rates can be determined in an exploratory manner.
;
Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
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