Phase II Study of a B7-1 Gene-Modified Autologous Tumor Cell Vaccine and Systemic IL-2
- Conditions
- Kidney Cancer
- Interventions
- Biological: Interleukin-2Biological: B7-1
- Registration Number
- NCT00031564
- Brief Summary
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.
- Detailed Description
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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 49
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description Vaccine Therapy With Interleukin-2 Interleukin-2 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. Vaccine Therapy With Interleukin-2 B7-1 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.
- Primary Outcome Measures
Name Time Method Percentage of Patients Who Have a Reduction in the Size of Their Measurable Metastatic Tumors 4 years 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.
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (1)
H. Lee Moffitt Cancer Center and Research Institute
🇺🇸Tampa, Florida, United States