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Phase II Randomized Study of Vaccine Treatment of Advanced Prostate Cancer (NCT00003871)

National Cancer Institute (NCI)
RATIONALE: Vaccines may make the body build an immune response to kill tumor cells. PURPOSE: Randomized phase II trial to study the effectiveness of different regimens of PSA vaccines in treating patients who have advanced prostate cancer.
  • Biological: fowlpox virus vaccine vector
    • Biological: recombinant vaccinia prostate-specific antigen vaccine
      Ages eligible for Study
      18 Years and older
      Genders eligible for Study
      Accepts Healthy Volunteers
      OBJECTIVES: I. Evaluate the effect of prime and boost strategies using recombinant fowlpox prostate specific antigen (PSA) vaccine and recombinant vaccinia PSA vaccine on biochemical PSA progression in patients with stage D0 prostate cancer who have completed local treatment. II. Assess the tolerability and toxicity of these prime and boost treatment regimens in these patients. III. Evaluate the effects of these prime and boost treatment regimens on cellular immunity in these patients.

      OUTLINE: This is a randomized study. Patients are stratified according to HLA-2 typing (positive vs negative vs unknown). Patients are randomized to one of three treatment arms. Arm I: Patients receive intramuscular fowlpox prostate specific antigen (PSA) vaccine at weeks 0, 6, 12, and 18. Arm II: Patients receive intramuscular fowlpox PSA vaccine at weeks 0, 6, and 12 and intradermal vaccinia PSA vaccine at week 18. Arm III: Patients receive intradermal vaccinia PSA vaccine at week 0 and intramuscular fowlpox PSA vaccine at weeks 6, 12, and 18. Patients are followed at week 24, then every 3 months until year 2, every 6 months until year 5, and annually thereafter.

      PROJECTED ACCRUAL: A total of 60 patients (20 per treatment arm) will be accrued for this study.

      10 locations

      United States (10)
      • Indiana University Cancer Center
        Indianapolis, Indiana, United States, 46202-5265
      • Veterans Affairs Medical Center - Indianapolis (Roudebush)
        Indianapolis, Indiana, United States, 46202
      • Beth Israel Deaconess Medical Center
        Boston, Massachusetts, United States, 02215
      • Cancer Institute of New Jersey
        New Brunswick, New Jersey, United States, 08901
      • Albert Einstein Comprehensive Cancer Center
        Bronx, New York, United States, 10461
      • Fox Chase Cancer Center
        Philadelphia, Pennsylvania, United States, 19111
      • University of Pittsburgh Cancer Institute
        Pittsburgh, Pennsylvania, United States, 15213
      • Vanderbilt Cancer Center
        Nashville, Tennessee, United States, 37232-6838
      • Veterans Affairs Medical Center - Madison
        Madison, Wisconsin, United States, 53705
      • University of Wisconsin Comprehensive Cancer Center
        Madison, Wisconsin, United States, 53792
      31 July, 1999
      25 January, 2010
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