SNPMiner Trials (Home Page)
Report for Clinical Trial NCT02754362
Developed by Shray Alag, 2020.
SNP Clinical Trial Gene
This is a phase II study to determine the immunogenicity and efficacy of a vaccine composed
of tumor associated long synthetic peptides mixed with Montanide ISA-51 VG administered with
polyinosinic-polycytidylic acid - poly-L-lysine carboxymethylcellulose (Poly-ICLC) and
bevacizumab in adults with recurrent glioblastoma.
Name: Bevacizumab
Description: Bevacizumab is a humanized monoclonal antibody that targets vascular endothelial growth factor (VEGF), a proangiogenic factor which aids in tumor vessel formation.
Type: Drug
Group Labels: 3 Block 1 Block 2 Block 3
Name: Peptide Vaccine
Description: Vaccine of long synthetic peptides encoding T cell epitopes in tumor associated antigens.
Vaccine Consists of:
EGFRvIII peptide 100 mcg IL13Ralpha peptide 100 mcg EphA2 peptide 100 mcg Her2/neu peptide 100 mcg YKL-40 peptide 100 mcg
Type: Biological
Group Labels: 2 Block 2 Block 3
Name: Poly-ICLC as immune adjuvant
Description: Poly-ICLC is a toll like receptor 3 agonist which directly activates dendritic cells and triggers natural killer cells to kill tumor cells.
Type: Drug
Group Labels: 2 Block 2 Block 3
Name: Keyhole limpet hemocyanin (KLH)
Description: Potent Immunogen used in vaccine approaches for a number of diseases including cancer, AIDS, and infectious diseases
Type: Drug
Primary Outcomes
Measure: Assays to determine immunity to the vaccine's antigen
Time: 9 Weeks
Measure: Measure of Humoral Immune Responses measured by ELISA
Time: 9 Weeks
Description: Measured either ex-vivo (assayed directly from thawed PBMCs) or following in-vitro pre-sensitization.
Measure: Antigen specific CD4+ and CD8+ T-cell reactivity to the peptide antigens measured by intracellular cytokine staining
Time: 9 Weeks
Measure: CD4+ and CD8+ T cell reactivity to KLH measured by T cell proliferation quantified by tritiated thymidine incorporation
Time: 9 Weeks
Measure: Measure of Tumor Responses measured by the Response Evaluation Criteria in Solid Tumors (RECIST).
Time: 1 Day
Purpose: Treatment
Allocation: Non-Randomized
Crossover Assignment
There is one SNP
SNPs
1 G20210A
- Patients must not have a known thrombophilic condition (i.e. protein S, protein C or
antithrombin III deficiency, Factor V Leiden, Factor II G20210A mutation,
homocysteinemia or antiphospholipid antibody syndrome). --- G20210A ---