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
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 49
- 试验地点
- 1
- 主要终点
- Percentage of Patients Who Have a Reduction in the Size of Their Measurable Metastatic Tumors
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •DISEASE CHARACTERISTICS:
- •Histologically confirmed stage IV renal cell carcinoma
- •Symptomatic primary tumor or resectable metastasis
- •Measurable disease post resection
- •No symptomatic brain metastases
- •PATIENT CHARACTERISTICS:
- •18 and over
- •Performance status:
- •Eastern Cooperative Oncology Group (ECOG) 0-1
- •Life expectancy:
- •Not specified
- •Hematopoietic:
- •WBC greater than 4,000/mm^3
- •Platelet count greater than 100,000/mm^3
- •Hemoglobin greater than 10 g/dL
- •Hematocrit greater than 30%
- •Bilirubin less than 2 times normal
- •SGOT less than 3 times normal
- •Creatinine less than 1.5 mg/dL OR
- •Creatinine clearance greater than 60 mL/min
- •Cardiovascular:
- •No evidence of active myocardial ischemia, prior myocardial infarction, or arrhythmia
- •Not pregnant or nursing
- •Negative pregnancy test
- •Fertile patients must use effective contraception
- •No contraindications to surgical resection
- •No history of immunodeficiency disease
- •No known allergy to penicillin
- •PRIOR CONCURRENT THERAPY:
- •Biologic therapy:
- •Prior interleukin-2, interferon alfa, or other biologic agent allowed
- •Chemotherapy:
- •Not specified
- •Endocrine therapy:
- •No concurrent corticosteroids (except for replacement doses for adrenal insufficiency)
- •Radiotherapy:
- •Not specified
- •See Disease Characteristics
- •No concurrent immunosuppressants
排除标准
- 未提供
研究组 & 干预措施
Vaccine Therapy With 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.
干预措施: B7-1 (Biological)
Vaccine Therapy With 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.
干预措施: Interleukin-2 (Biological)
结局指标
主要结局
Percentage of Patients Who Have a Reduction in the Size of Their Measurable Metastatic Tumors
时间窗: 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.
次要结局
未报告次要终点