Vaccine Therapy Plus QS21 in Treating Patients With Prostate Cancer

Phase 1

Completed

• Conditions: Prostate Cancer

• Registration Number: NCT00005632
• Lead Sponsor: Memorial Sloan Kettering Cancer Center

Brief Summary

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.

Detailed Description

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.

Study Timeline

• Study Start: 1999-06
• Study First Submitted: 2000-05-02
• Study First Submitted QC: 2004-07-16
• Study First Posted: 2004-07-19
• Primary Completion: 2009-03
• Study Completion: 2009-03
• Status Verified: 2013-01
• Last Update Submitted: 2013-01-30
• Last Update Posted: 2013-01-31

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Male
• Target Recruitment: 27

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Trial Locations

Locations (1)

Memorial Sloan-Kettering Cancer Center; 🇺🇸 New York, New York, United States