Spots Global Cancer Trial Database for Vaccine Therapy Plus QS21 in Treating Patients With Progressive Prostate Cancer

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Trial Identification

Brief Title: Vaccine Therapy Plus QS21 in Treating Patients With Progressive Prostate Cancer

Official Title: Vaccination of Prostate Cancer Patients With MUC-2-KLH Conjugate Plus the Immunological Adjuvant QS21: A Trial Examining the Immunogenicity of Glycosylated MUC-2-KLH Peptide Conjugate Vaccine

Study ID: NCT00004929

Conditions

Prostate Cancer

Interventions

MUC-2-KLH vaccine

QS21

Study Description

Brief Summary: RATIONALE: Vaccines may make the body build an immune response to kill tumor cells. PURPOSE: Phase II trial to study the effectiveness of vaccine therapy given with QS21 in treating patients who have progressive prostate cancer.

Detailed Description: OBJECTIVES: I. Determine if immunization with glycosylated MUC-2 antigen with keyhole limpet hemocyanin (KLH) conjugate plus immunological adjuvant QS21 induces an antibody, helper T cell, and/or cytotoxic T cell response against glycosylated MUC-2 in patients with progressive prostate cancer. II. Determine the safety of this treatment regimen in this patient population. III. Determine the effect of glycosylated MUC-2 antigen with KLH conjugate on the T cell response against MUC-2 and by skin testing in these patients. IV. Assess the post immunization changes in prostate specific antigen levels and other objective parameters of disease including radionuclide bone scan and/or measurable disease in these patients. OUTLINE: Patients receive vaccination with glycosylated MUC-2 antigen with keyhole limpet hemocyanin conjugate subcutaneously (SQ) plus immunological adjuvant QS21 SQ on weeks 1-3, 7, 15, and 27 for a total of 6 vaccinations. Patients are followed every 3 months for 1 year or until disease progression. PROJECTED ACCRUAL: A total of 3-15 patients will be accrued for this study within 1 year.