Vaccine Therapy in Treating Patients With Metastatic Prostate Cancer

Phase 1

Completed

• Conditions: Prostate Cancer

• Registration Number: NCT00004211
• Lead Sponsor: Duke University

Brief Summary

RATIONALE: Vaccines may make the body build an immune response to kill tumor cells.

PURPOSE: Phase I/II trial to study the effectiveness of vaccine therapy in treating patients who have metastatic prostate cancer.

Detailed Description

OBJECTIVES: I. Determine the safety and feasibility of prostate specific antigen (PSA) RNA pulsed autologous dendritic cells in patients with metastatic prostate cancer. II. Evaluate the presence and magnitude of cellular immune responses against PSA as a surrogate target for immune activation in this patient population. III. Assess the presence, frequency, and activation status of peripheral cytotoxic T lymphocytes prior to and following immunotherapy with this regimen in these patients. IV. Evaluate humoral immune responses as evidenced on circulating peripheral PSA specific antibodies in this patient population. V. Evaluate delayed type hypersensitivity reactions to irradiated PSA RNA transfected dendritic cells and other standard recall antigens prior to and following immunotherapy in these patients. VI. Evaluate eventual clinical responses as evidenced on clinical and biochemical (PSA) response criteria.

OUTLINE: This is a dose escalation study. Patients receive prostate specific antigen (PSA) RNA pulsed autologous dendritic cells IV over 2 minutes followed by PSA RNA dendritic cells intradermally on weeks 0, 2, and 4 for a total of 3 treatments. Cohorts of 3-6 patients receive escalating doses of PSA RNA pulsed autologous dendritic cells until the maximum tolerated dose (MTD) is determined. The MTD is defined as the dose preceding that at which 2 of 6 patients experience dose limiting toxicity. Patients are followed weekly for 3 months, then every 3 months for 1 year, and then annually thereafter.

PROJECTED ACCRUAL: A total of 3-18 patients will be accrued for this study within 24 months.

Study Timeline

• Study Start: 1999-07
• Study First Submitted: 2000-01-21
• Study Completion: 2002-01
• Study First Submitted QC: 2004-05-19
• Study First Posted: 2004-05-20
• Status Verified: 2005-01
• Last Update Submitted: 2013-03-19
• Last Update Posted: 2013-03-21

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Male
• Target Recruitment: 17

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: Not specified

Trial Locations

Locations (1)

Duke Comprehensive Cancer Center; 🇺🇸 Durham, North Carolina, United States