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Vaccine Therapy in Treating Patients With Stage III or Stage IV Kidney Cancer

Kidney Cancer Clinical Trial

Official title:
Active Immunotherapy of Metastatic Renal Cell Carcinoma Using Autologous Dendritic Cells Transfected With Autologous Total Tumor RNA

Clinical Trial Summary

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.

Clinical Trial Description

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. ;

Study Design

Primary Purpose: Treatment

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT00005816
Study type Interventional
Source Duke University
Contact
Status Completed
Phase Phase 1
Start date February 2000
Completion date August 2002
View Details
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