Kidney Cancer Clinical Trial
Official 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
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.
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.
;
Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
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