Vaccine Therapy Plus QS21 in Treating Patients With Prostate Cancer
RATIONALE: Vaccines may make the body build an immune response to kill tumor cells. Combining a vaccine with QS21 may kill more tumor cells.
PURPOSE: Phase I trial to study the effectiveness of vaccine therapy plus immune adjuvant QS21 in treating patients who have prostate cancer.
|Study Design:||Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||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|
|Study Start Date:||June 1999|
|Study Completion Date:||March 2009|
|Primary Completion Date:||March 2009 (Final data collection date for primary outcome measure)|
Patients sequentially will receive glycosylated MUC-1-KLH vaccines at 3ug per vaccination.
|Biological: MUC1-KLH vaccine/QS21|
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.
|United States, New York|
|Memorial Sloan-Kettering Cancer Center|
|New York, New York, United States, 10021|
|Study Chair:||Susan Slovin, MD, PhD||Memorial Sloan-Kettering Cancer Center|