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Protocol Number: 03-C-0176 
" Adenocarcinoma of the prostate is the most common cancer diagnosis in American males and follows lung cancer as the leading cause of cancer death. " Vaccine strategies represent a novel therapeutic approach in the treatment for prostate cancer. One potential target for a prostate cancer vaccine is PSA, due to its restricted expression on prostate cancer and normal prostatic epithelial cells. Objectives: " The primary objective in Stage 1 is to evaluate the clinical safety and toxicity of a prime/boost vaccine strategy: priming with rVaccinia-PSA(L155)-TRICOM (rV-PSA-(L155)-TRICOM) with subsequent monthly boosts using rFowlpox-PSA(L155)-TRICOM (rF-PSA(L155)-TRICOM). " The primary objective in Stage 2 is to determine the impact of granulocyte-macrophage colony stimulating factor (GM-CSF) and rF-GM-CSF on the immunologic response in patients treated with these vaccines. " Secondary (both Stage 1 and Stage 2)-to determine the change in PSA-specific T cells in patients treated with these vaccines using ELISPOT assay analysis. " To document any objective anti-tumor responses that may occur. Eligibility: " Patients must have androgen insensitive metastatic prostate cancer. " All patients will have received and progressed on hormonal therapy. " Must have objective evidence of metastasis or relapsing local disease. Therefore, must have a rising PSA and at least one of the following: positive bone scan, palpable disease, or positive imaging studies. " Must have a life expectancy of more than 6 months and ECOG status of 0 to 2. " For Stage 2 of this study, patients must be HLA-A2+. " Granulocyte count greater than or equal to 1,500/mm(3), Platelet greater than or equal to 100,000/mm(3), Hgb greater than or equal to 10Gm/dL, Lymphocyte count greater than or equal to 500/mm(3) ;Bilirubin less than 1.5mg/dL, AST and ALT less than 2.5xULN,CreatinineClearance greater than or equal to 60 " No significant cardiac disease, no significant pulmonary disease, no serious inter-current medical illness. Design: " This study will utilize a dose escalation Phase I design. Stage 1 will consist of five cohorts as shown in the schema. " The first cohort utilizes a fixed dose of rF-PSA (L155)-TRICOM alone, while the second cohort will test the safety of rV-PSA(L155)-TRICOM as a priming vaccination followed by monthly boosting with rF-PSA (L155)-TRICOM. " Cohorts three, four and five will provide safety data combining cohort two with rGM-CSF as well as two doses of rFGM-CSF respectively. The maximal tolerated dose (MTD) established in Stage 1 (cohorts 2-5) of this trial will be used in Stage 2 of the protocol. " Stage 2 will be conducted as a small, randomized pilot study to compare the immunologic effects of the above vaccine strategy alone, with recombinant GM-CSF, or with either of 2 doses of fowlpox-GM-CSF. " Stage 2 will consist of 4 randomized arms of 8 patients each, all of whom are HLA-A2+. The maximum accrual to the trial should be 62: up to 30 patients in Stage 1 (5 cohorts of up to 6 patients), and 32 patients in Stage 2 (4 arms of 8 patients apiece).
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National Institutes of Health Clinical Center