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
- 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
Percentage of Patients Who Have a Reduction in the Size of Their Measurable Metastatic Tumors
The primary objective of this phase II trial involving 30 patients will be to determine tumor response rates. The immunogenicity of the treatment will be assessed by ELISPOT assays performed on the patients' peripheral blood lymphocytes, and by an immunohistochemical analysis of DTH skin tests site biopsies performed 48 hours after the intradermal injection of autologous, unmodified tumor cells.
Scott J. Antonia, M.D., Ph.D.
H. Lee Moffitt Cancer Center and Research Institute
United States: Food and Drug Administration
|H. Lee Moffitt Cancer Center and Research Institute||Tampa, Florida 33612|