High Risk WHO Grade II Glioma Clinical Trial
Official title:
A Pilot Study to Evaluate the Effects of Imiquimod and Tumor Lysate Vaccine Immunotherapy for Adults With High Risk or Recurrent/Post-Chemotherapy WHO Grade II Gliomas
This is a pilot study of a vaccination regime that is designed to efficiently induce anti-tumor T-cell responses in patients with WHO grade II glioma. The proposed regime with BTIC Lysate in combination with imiquimod, an FDA-approved immune response modifier will induce potent anti-glioma immune response with minimal or no toxicity.
To determine the response rate and magnitude of CD8+ T-cell responses against the
Imiquimod/BTIC lysate-based vaccines in post-vaccine PBMC using IFN- ELISPOT. ELISPOT assays
indicate functional status of the antigen-specific T cells as cytokine-expression, and we are
particularly interested in Type-1 (i.e. IFN expressing) T cell response. Therefore, IFN
ELISPOT will be used as the primary assay for the immunological endpoint.
Using flow-cytometry, we will also evaluate the numbers of lymphocyte subsets such as CD4+ T
cells, CD4+/Foxp3+ regulatory T cells in an exploratory manner. In addition, in participants
who undergo surgical debulking of the progressing tumor, if the tumor tissue is available,
infiltration of antigen-specific CTLs will be evaluated by flow cytometry of
tumor-infiltrating lymphocytes with the Imiquimod/BTIC lysate-based vaccine-targeted GAA
specific MHC-tetramers. In addition, serological responses will be evaluated with
flow-cytometry of BTIC cells as well as western blotting. These plans (in this paragraph) are
immunological evaluations; however, do not compose the primary endpoints due to their
exploratory nature.
We will determine whether it is safe to administer Imiquimod/BTIC lysate-based vaccines in
patients with grade II gliomas. Endpoints will therefore include incidence and severity of
adverse events, using standard criteria as well as close clinical follow-up as would be
performed normally in this group of participants following vaccinations. All reported or
observed toxicities and adverse events at all clinic visits will be graded, documented and
reported according to a standard toxicity table, the Common Terminology Criteria for Adverse
Events (CTCAE) version 4.0
;