Pilot Immunotherapy Study of Combination PSMA and TARP Peptide With Poly IC-LC Adjuvant in HLA-A2 (+) Patients With Elevated PSA After Initial Definitive Treatment
1. Estimate the frequency of immunological efficacy of the vaccine by comparison of the in
vitro enzyme-linked immunosorbent spot (ELISpot) test results, for each antigen (PSMA,
TARP) from peripheral blood specimens collected during the periods of time defined as
"before", "during" and "after" vaccination.
2. Study the safety and toxicity of varying doses of polypeptide vaccines:
PSMA27-35-PSMA687-701 (VLAGGFFLLYRHVIYAPSSHNKYA) and TARP13-35
(LQLLKQSSRRLEHTFMFLRNFSL) administered with a fixed dose of Poly IC-LC (2 mg
total/treatment) as adjuvant.
3. Describe the impact of the vaccine on the pattern of PSA change in 2 subsets of
patients: with castrate testosterone; with non-suppressed testosterone level/not on
4. Identify if there is a basis for selection of a dose of the PSMA and the TARP
polypeptide vaccines for future phase II development of this vaccination strategy,
considering the dose range tested.
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Number of Participants With Related Adverse Events
Establish the safety and toxicity of varying doses of polypeptide vaccines PSMA and TARP administered with a fixed dose of Poly IC-LC as an adjuvant.
Approximately 24 months
Mayer Fishman, M.D., Ph.D.
H. Lee Moffitt Cancer Center and Research Institute
United States: Institutional Review Board
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