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A Toll-like Receptor Agonist as an Adjuvant to Tumor Associated Antigens (TAA) Mixed With Montanide ISA-51 VG With Bevacizumab for Patients With Recurrent Glioblastoma
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.
Details
| Lead sponsor | NYU Langone Health |
|---|---|
| Phase | Phase 2 |
| Status | WITHDRAWN |
| Start date | 2016-11 |
| Completion | 2019-06 |
Conditions
- Glioblastoma
- Glioma
Interventions
- Bevacizumab
- Peptide Vaccine
- Poly-ICLC as immune adjuvant
- Keyhole limpet hemocyanin (KLH)
Primary outcomes
- Assays to determine immunity to the vaccine's antigen — 9 Weeks
- Measure of Humoral Immune Responses measured by ELISA — 9 Weeks
- Antigen specific CD4+ and CD8+ T-cell reactivity to the peptide antigens measured by intracellular cytokine staining — 9 Weeks
Measured either ex-vivo (assayed directly from thawed PBMCs) or following in-vitro pre-sensitization. - CD4+ and CD8+ T cell reactivity to KLH measured by T cell proliferation quantified by tritiated thymidine incorporation — 9 Weeks
- Measure of Tumor Responses measured by the Response Evaluation Criteria in Solid Tumors (RECIST). — 1 Day
Countries
United States