A phase I study of sequential vaccinations with recombinant Fowlpox-PSA (L155)-TRICOM (rF)alone, or in combination with recombinant vaccinia-PSA (L155)-TRICOM (rV), and the role of GM-CSF, in patients (Pts) with prostate cancer

Abstract
2522 Background: Vaccine strategies targeting PSA represent a novel approach in the treatment of prostate cancer. Since PSA is a “self” antigen, vaccine strategies utilizing this as a target must be developed to enhance its immunogenicity. Previous studies have shown that the induction of T-cell responses directed against a self-antigen is associated with anti-tumor activity but not toxicity. Two novel vaccines have been developed: (a) a recombinant vaccinia virus containing the entire PSA transgene with a modified agonist epitope and three costimulatory molecule transgenes rV and (b) a similar recombinant fowlpox virus rF. Methods: This Phase I study evaluated the safety of a diversified prime/boost vaccine strategy: priming with rV and monthly boosts using rF. All pts had progressive metastatic prostate cancer. This trial also examined the combination of these agents with recombinant GM-CSF (rG) as well as two doses of fowlpox-GM-CSF (rF-G). The first of 5 cohorts utilized a fixed dose of rF alone, the ...

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