Vaccine Therapy in Treating Patients With Stage III or Stage IV Kidney Cancer
RATIONALE: Vaccines 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 stage III or stage IV kidney cancer.
Biological: therapeutic autologous dendritic cells
Procedure: conventional surgery
|Study Design:||Primary Purpose: Treatment|
|Official Title:||Active Immunotherapy of Metastatic Renal Cell Carcinoma Using Autologous Dendritic Cells Transfected With Autologous Total Tumor RNA|
|Study Start Date:||February 2000|
|Study Completion Date:||August 2002|
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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00005816
|United States, North Carolina|
|Duke Comprehensive Cancer Center|
|Durham, North Carolina, United States, 27710|
|Study Chair:||Johannes Vieweg, MD||Duke Cancer Institute|