Phase II Study of a B7-1 Gene-Modified Autologous Tumor Cell Vaccine and Systemic IL-2

NCT ID: NCT00031564


Title
Phase II Study of a B7-1 Gene-Modified Autologous Tumor Cell Vaccine and Systemic IL-2 for Patients With Stage IV Renal Cell Carcinoma
Purpose
RATIONALE: Vaccines made by inserting a laboratory-treated gene into a person's tumor cells may make the body build an immune response to kill tumor cells. Interleukin-2 may stimulate a person's white blood cells to kill cancer cells. Combining vaccine therapy with interleukin-2 may kill more tumor cells. PURPOSE: Phase II trial to study the effectiveness of combining vaccine therapy with interleukin-2 in treating patients who have stage IV kidney cancer.
Details
OBJECTIVES: - Determine the percentage of patients with stage IV renal cell carcinoma with a reduction in tumor size after treatment with B7-1 gene-modified autologous tumor cell vaccine and interleukin-2. - Determine the immunogenicity of this regimen in these patients. - Determine the overall survival of patients treated with this regimen. - Determine the local and systemic toxicity of this regimen in these patients. OUTLINE: Tumor tissue for vaccine preparation is obtained when patients undergo palliative surgical resection of primary tumor or therapeutic resection of metastasis. At approximately 3-6 weeks after surgery, patients receive B7-1 gene-modified autologous tumor cell vaccine subcutaneously (SC) once on days 1, 29, and 57. At 6 weeks after the first vaccination, patients receive interleukin-2 (IL-2) SC five days a week for 6 weeks (days 43-82). Patients with stable or responding disease after day 106 may receive additional vaccinations in the absence of disease progression or unacceptable toxicity. Patients are followed at 3 weeks after the last dose of IL-2. PROJECTED ACCRUAL: Approximately 30 patients will be accrued for this study.
Conditions
Kidney Cancer
Keywords
stage IV, renal cell carcinoma
Source
H. Lee Moffitt Cancer Center and Research Institute
Sponsors
H. Lee Moffitt Cancer Center and Research Institute, National Cancer Institute (NCI), Chiron Corporation
Status
Completed
Acronym
Last Updated
25 Sep 2012
URL
Official Link
Citations/Publications
Fishman M, Hunter TB, Soliman H, Thompson P, Dunn M, Smilee R, Farmelo MJ, Noyes DR, Mahany JJ, Lee JH, Cantor A, Messina J, Seigne J, Pow-Sang J, Janssen W, Antonia SJ. Phase II trial of B7-1 (CD-86) transduced, cultured autologous tumor cell vaccine plus subcutaneous interleukin-2 for treatment of stage IV renal cell carcinoma. J Immunother. 2008 Jan;31(1):72-80.

Locations
United States