Prostate Cancer Clinical Trial
Official title:
Vaccination Of Prostate Cancer Patients With A Bivalent Vaccine Containing MUC-2 Glycopeptide And Globo H Conjugates Plus The Immunological Adjuvant QS21
RATIONALE: Vaccines may make the body build an immune response to kill tumor cells.
Biological therapies such as QS21 use different ways to stimulate the immune system and stop
cancer cells from growing. Combining vaccine therapy with QS21 may kill more tumor cells.
PURPOSE: Phase II trial to study the effectiveness of combining vaccine therapy with QS21 in
treating patients who have prostate cancer.
OBJECTIVES:
- Determine the safety of glycosylated MUC-2-Globo H-KLH conjugate vaccine with adjuvant
QS21 in patients with prostate cancer.
- Determine the antibody response in patients treated with this vaccination therapy.
- Assess post-immunization changes in PSA levels and other objective parameters of
disease (radionuclide bone scan) in patients treated with this vaccination therapy.
OUTLINE: Patients receive glycosylated MUC-2-Globo H-KLH conjugate vaccine with adjuvant
QS21 subcutaneously once weekly on weeks 0-2, 6, 14, and 26 in the absence of unacceptable
toxicity. Patients whose antibody titers against Globo-H or MUC-2 antigens fall below 1/40
and who have no disease progression may receive a seventh vaccination after week 50.
Patients are followed every 3 months for 1 year or until biochemical relapse or radiographic
disease progression.
;
Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
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