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Vaccination of Prostate Cancer Patients With Thompson-Friedenreich [TF(c)]-KLH Conjugate Plus the Immunological Adjuvant QS21: A Trial Comparing TF(c)-KLH Doses (NCT00003819)

National Cancer Institute (NCI)
RATIONALE: Vaccines may make the body build an immune response to kill tumor cells. PURPOSE: Phase I trial to study the effectiveness of vaccine therapy given with QS21 in treating patients who have progressive prostate cancer.
  • Biological: QS21
    • Biological: TF(c)-KLH conjugate vaccine
      • Biological: Thomsen-Friedenreich antigen
        • Biological: keyhole limpet hemocyanin
          Ages eligible for Study
          18 Years and older
          Genders eligible for Study
          Male
          Accepts Healthy Volunteers
          No
          OBJECTIVES: I. Determine the optimal dose of Thompson-Friedenreich [TF(c)]-keyhole limpet hemocyanin (KLH) conjugate plus adjuvant QS21 that induces an antibody response in patients with prostate cancer. II. Determine the safety of the TF(c)-KLH conjugate prepared using an MBS heterobifunctional linker plus QS21. III. Assess postimmunization changes in prostate specific antigen levels and other objective parameters of disease in these patients.

          OUTLINE: This is a dose escalation study. Patients receive TF(c)-KLH conjugate with adjuvant QS21 subcutaneously weekly for 3 weeks, then once during weeks 7 and 19. Cohorts of 5 patients each receive escalating doses of TF(c)-KLH vaccine until the optimal dose, based on antibody response, is reached. Patients are followed monthly for 6 months, then every 3 months for 1 year.

          1 locations

          United States (1)
          • Memorial Sloan-Kettering Cancer Center
            New York, New York, United States, 10021
          Status:
          completed
          Type:
          Interventional
          Phase:
          Start:
          31 May, 1998
          Updated:
          17 March, 2013
          Participants:
          21
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