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A PHASE I TRIAL OF RECOMBINANT VACCINIA VIRUS THAT EXPRESSES PSA IN PATIENTS WITH ADENOCARCINOMA OF THE PROSTATE (NCT00004029)

Phase I trial to study the effectiveness of vaccine therapy in treating patients with metastatic prostate cancer. Vaccines may make the body build an immune response to kill tumor cells.
  • Biological: recombinant viral vaccine therapy
    • Biological: sargramostim
      Ages eligible for Study
      18 Years and older
      Genders eligible for Study
      Male
      Accepts Healthy Volunteers
      No
      OBJECTIVES:

      I. Assess the toxicity associated with repeated vaccination with recombinant vaccinia virus expressing prostate-specific antigen (rV-PSA) in patients with metastatic adenocarcinoma of the prostate.

      II. Determine the optimal dose of rV-PSA given at monthly intervals based on cellular and hormonal immunity.

      III. Determine whether vaccination with rV-PSA is associated with anti-tumor activity.

      IV. Determine whether granulocyte-macrophage colony-stimulating factor (GM-CSF) has an effect on cellular and humoral immunity different from rV-PSA, and whether the addition of GM-CSF has enhanced antitumor effect compared to rV-PSA alone.

      OUTLINE: This is an open label, dose escalation study.

      Patients in cohorts of 3-6 receive 3 vaccinations with rV-PSA at 4-week intervals (days 1, 29, 57, and 85) in the absence of disease progression or unacceptable toxicity. Response assessment is performed at eight weeks. Patients who discontinue therapy prior to eight weeks are considered unevaluable for response. If dose limiting toxicity is observed in 2 of 6 patients entered at a dose level, no further patients are entered at that level and the MTD is defined as the preceding dose level. Ten additional patients are treated at the MTD and receive granulocyte-macrophage colony-stimulating factor (GM-CSF) administered subcutaneously on day -1 through day 2 of each cycle. Patients who are HLA-A2 positive, have received all 3 rV-PSA vaccinations without unacceptable toxicity, and have been off study for at least 30 days due to disease progression may continue treatment with rV-PSA at the highest dose level and the addition of GM-CSF.

      Patients are followed monthly for 6 months.

      3 locations

      United States (3)
      • Massachusetts General Hospital Cancer Center
        Boston, Massachusetts, United States, 02114
      • Brigham and Women's Hospital
        Boston, Massachusetts, United States, 02115
      • Dana-Farber Cancer Institute
        Boston, Massachusetts, United States, 02115
      Status:
      completed
      Type:
      Interventional
      Phase:
      Start:
      30 November, 1996
      Updated:
      07 February, 2013
      Participants:
      46
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