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
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
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.
Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Susan Slovin, MD, PhD
Memorial Sloan-Kettering Cancer Center
United States: Food and Drug Administration
|Memorial Sloan-Kettering Cancer Center||New York, New York 10021|