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
Part of paid clinical trials in New York, New York.
- Sponsor
- NYU Langone Health
- Study ID
- NCT02754362
- Phase
- PHASE2
- Status
- Withdrawn
Conditions
Eligibility Criteria
- Sex
- ALL
- Age
- 18 Years - N/A
- Healthy Volunteers
- Not accepted
Interventions
- Bevacizumab — DRUGBevacizumab is a humanized monoclonal antibody that targets vascular endothelial growth factor (VEGF), a proangiogenic factor which aids in tumor vessel formation.
- Peptide Vaccine — BIOLOGICALVaccine 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
- Poly-ICLC as immune adjuvant — DRUGPoly-ICLC is a toll like receptor 3 agonist which directly activates dendritic cells and triggers natural killer cells to kill tumor cells.
- Keyhole limpet hemocyanin (KLH) — DRUGPotent Immunogen used in vaccine approaches for a number of diseases including cancer, AIDS, and infectious diseases
Study Details
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.
Key Dates
- First listed
- Apr 28, 2016
- Start date
- Nov 30, 2016
- Status verified
- Jan 2020
- Primary completion
- Jun 30, 2019
- Completion
- Jun 30, 2019
Study Design
- Enrollment
- 0 participants (actual)
- Allocation
- NON_RANDOMIZED
- Intervention model
- CROSSOVER
- Primary purpose
- TREATMENT
Arms
- Experimental: Block 1
- Experimental: Block 2
- Experimental: Block 3
Primary Outcome Measure
Assays to determine immunity to the vaccine's antigen [ Time Frame: 9 Weeks ]
Locations (1)
| Facility | City | State | ZIP | Site coordinators |
|---|---|---|---|---|
| NYU Perlmutter Cancer Center | New York | New York | 10016 | - |
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