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
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.
Primary Purpose: Treatment
Arie Belldegrun, MD, FACS
Jonsson Comprehensive Cancer Center
United States: Federal Government
|University of Texas - MD Anderson Cancer Center
|Houston, Texas 77030-4009
|Jonsson Comprehensive Cancer Center, UCLA
|Los Angeles, California 90095-1781