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Withdrawn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 — DRUG
    Bevacizumab is a humanized monoclonal antibody that targets vascular endothelial growth factor (VEGF), a proangiogenic factor which aids in tumor vessel formation.
  • Peptide Vaccine — BIOLOGICAL
    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
  • Poly-ICLC as immune adjuvant — DRUG
    Poly-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) — DRUG
    Potent 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)

FacilityCityStateZIPSite coordinators
NYU Perlmutter Cancer CenterNew YorkNew York10016-

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