Prostate Cancer Clinical Trial
Official title:
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
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.
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
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