A Safety and Feasibility Study of Active Immunotherapy in Patients With Metastatic Prostate Carcinoma Using Autologous Dendritic Cells Pulsed With RNA Encoding Prostate Specific Antigen, PSA
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)
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.
Primary Purpose: Treatment
Johannes Vieweg, MD
Duke Cancer Institute
United States: Federal Government
|Duke Comprehensive Cancer Center||Durham, North Carolina 27710|