A Safety and Feasibility Study of Active Immunotherapy in Patients With Metastatic Prostate Carcinoma Using Autologous Dendritic Cells Pulsed With Antigen Encoded in Amplified Autologous Tumor RNA
- Determine the safety and feasibility of autologous dendritic cells transfected with
autologous total tumor RNA in patients with metastatic prostate cancer.
- Determine the presence, frequency, and activation status of tumor specific and prostate
specific antigen (PSA) specific cellular immune responses in patients treated with this
- Determine delayed-type hypersensitivity reactions to PSA protein and other recall
antigens in patients before and after being treated with this regimen.
- Determine clinical responses based on clinical and biochemical (PSA) response criteria
in patients treated with this regimen.
- Determine a platform for immunological treatment using dendritic-cell based tumor
vaccines in these patients.
OUTLINE: This is a dose escalation study.
Tumor tissue and peripheral blood stem cells are collected from patients and cultured in
vitro with sargramostim (GM-CSF) and interleukin-4 for 7 days to produce dendritic cells
(DC). Patients receive autologous DC transfected with autologous prostate carcinoma RNA
intradermally once weekly on weeks 0-3 for a total of 4 doses.
Cohorts of 3-6 patients receive escalating doses of DC until the maximum tolerated dose
(MTD) is determined. The MTD is defined as the dose preceding that at which 2 of 3 or 2 of 6
patients experience dose-limiting toxicity.
Patients are followed at weeks 6, 8, 10, and 12; every 3 months for 9 months; and then
annually for 2 years.
PROJECTED ACCRUAL: A total of 18 patients will be accrued for this study within 20 months.
Primary Purpose: Treatment
Johannes Vieweg, MD
Duke Cancer Institute
United States: Federal Government
|Duke Comprehensive Cancer Center||Durham, North Carolina 27710|