Clinical Trial: Effects of Vaccinations With HLA-A2-Restricted Glioma Antigen-Peptides in Combination With Poly-ICLC for Adults With High-Risk WHO Grade II Astrocytomas and Oligo-Astrocytomas

Study Status: Completed
Recruit Status: Completed
Study Type: Interventional

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

Brief Summary:

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.


Detailed Summary: 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.
Sponsor: Ian F. Pollack, M.D.

Current Primary Outcome:

  • Induction of GAA-specific T-cell response [ Time Frame: 2 year ]
  • The incidence and severity of adverse events associated with the vaccine regime will be assessed, with an early stopping rule based on the frequency of Regimen Limiting Toxicity (RLT). [ Time Frame: 1 year ]


Original Primary Outcome: Same as current

Current Secondary Outcome:

  • Clinical Response: Radiological response will be determined using the standard WHO response criteria. Based on serial magnetic resonance imaging (MRI) scans 2-year progression-free survival (PFS) will be evaluated in an exploratory manner. [ Time Frame: 3 years ]
  • Biopsy/resection will be encouraged for patients who develop progression. Whenever post-vaccine tumor tissues are available, they will be analyzed for GAA expression status and infiltration of GAA-specific T-cells. [ Time Frame: 3 years ]
  • Influence of RT on induction of GAA-specific immune response: we will compare the rate and magnitude of GAA-specific immune responses in Cohorts 1 and Cohort 2 using IFN-gamma-enzyme-linked immuno-spot (ELISPOT), and tetramer assays. [ Time Frame: 3 years ]


Original Secondary Outcome: Same as current

Information By: University of Pittsburgh

Dates:
Date Received: November 19, 2008
Date Started: January 2009
Date Completion:
Last Updated: December 13, 2015
Last Verified: December 2015