NCT00005992

Vaccine Therapy in Treating Patients With Metastatic Prostate Cancer That Has Not Responded to Hormone Therapy

Phase I Clinical Trial of Recombinant Prostate Specific Membrane Antigen (rPSMA)-Loaded Mature Autologous Dendritic Cells (CapPVax) for the Treatment of Metastatic Horomone Refractory Prostate Cancer

• Status: Unknown
• Phase: Phase 1
• Study type: Interventional
• Enrollment: —
• Sponsor: Jonsson Comprehensive Cancer Center · Academic / Other
• Sex: Male
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

RATIONALE: Vaccines made from a person's peripheral stem cells may make the body build an immune response to kill tumor cells. PURPOSE: Phase I trial to study the effectiveness of vaccine therapy in treating patients who have metastatic prostate cancer that has not responded to hormone therapy.

Detailed description

OBJECTIVES: I. Assess the safety of recombinant prostate-specific membrane antigen (rPSMA)-pulsed autologous dendritic cells (CaPVax) in patients with metastatic hormone-refractory prostate cancer. II. Determine the potential clinical response in patients treated with this regimen. III. Determine the effect of this treatment regimen on pain, physical function, and quality of life of these patients. OUTLINE: This is a dose-escalation, multicenter study. Patients undergo a delayed hypersensitivity skin test with 3 common recall antigens. Autologous dendritic cells (DC) are pulsed with recombinant prostate-specific membrane antigen (rPSMA). Patients receive rPSMA-pulsed autologous DC (CaPVax) intradermally. Treatment repeats every 4 weeks for a total of 4 courses in the absence of disease progression or unacceptable toxicity. Cohorts of 3-6 patients receive escalating doses of CaPVax 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. Quality of life questionnaires are completed five times over the course of the study. Patients are followed at 3 months. PROJECTED ACCRUAL: A total of 60 patients will be accrued for this study.

Conditions

• Prostate Cancer

Interventions

Type	Name	Description
BIOLOGICAL	PSA prostate cancer vaccine
BIOLOGICAL	therapeutic autologous dendritic cells

Timeline

• Start date: 2000-12-01
• First posted: 2004-03-24
• Last updated: 2013-08-07

Locations

2 sites across 1 country: United States