Active Immunotherapy of Metastatic Renal Cell Carcinoma Using Autologous Dendritic Cells Transfected With Autologous Total Tumor RNA
OBJECTIVES: I. Determine the maximum tolerated dose of autologous dendritic cells
transfected with autologous total tumor RNA in patients with stage III or IV renal cell
carcinoma. II. Assess the toxicity and feasibility of this treatment regimen in these
patients. III. Evaluate this regimen in terms of cellular immune response, clinical
response, and overall survival in these patients.
OUTLINE: This is a dose-escalation study. Patients undergo nephrectomy for tumor RNA
extraction followed by leukapheresis to collect peripheral blood mononuclear cells for
dendritic cell (DC) production. Patients receive autologous DC transfected with autologous
renal cell carcinoma RNA both IV and intradermally on weeks 0, 2, and 4. Cohorts of 3-6
patients receive escalating doses of DC IV 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 every 3 months for 1 year and then
every 6 months for 1 year.
PROJECTED ACCRUAL: A total of 18 patients will be accrued for this study over 24 months.
Primary Purpose: Treatment
Johannes Vieweg, MD
Duke Cancer Institute
United States: Food and Drug Administration
|Duke Comprehensive Cancer Center||Durham, North Carolina 27710|