Vaccination of Prostate Cancer Patients With MUC-1-KLH Conjugate Plus the Immunological Adjuvant QS21: A Trial Examining the Immunogenicity of MUC-1 Glycopeptide Conjugate
OBJECTIVES: I. Determine if immunization with glycosylated MUC-1 antigen containing MUC-1
(106) with keyhole limpet hemocyanin conjugate plus immunological adjuvant QS21 induces an
antibody, helper T cell and/or cytotoxic T cell response against MUC-1 in patients with
prostate cancer expressing MUC-1. II. Determine post-immunization changes in PSA levels and
other objective parameters or disease (radionuclide bone scan and/or measurable disease if
present) in these patients after receiving this therapy.
OUTLINE: Patients receive glycosylated MUC-1 antigen containing MUC-1 (106) 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 documented disease progression.
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|