Granulocyte-macrophage Colony-stimulating Factor, Interferon Alpha and Interleukin-2 as Adjuvant Treatment for High-risk Renal Cell Carcinoma
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 35
- 试验地点
- 1
- 主要终点
- Disease-free survival (DFS)
研究概览
简要总结
This prospective study assesses toxicity and potential efficacy of granulocyte-macrophage colony-stimulating factor (GM-CSF), interferon (IFN) alpha and interleukin-2 (IL-2) postoperatively in patients with high-risk renal cell carcinoma (RCC).
详细描述
Patients with high-risk RCC have a dismal prognosis. To date, no effective adjuvant therapy exists for this patients category. We suggest that combination of granulocyte-macrophage colony-stimulating factor (GM-CSF), interferon alpha (IFN) and interleukin-2 (IL-2) stimulate immune system from dendritic cells till cytotoxic T-lymphocytes step by step and eliminate residuary tumor cells.
This prospective, non-randomized, phase II trial assessed low-dose GM-CSF, IFN and IL-2 postoperatively in patients with high-risk renal cell carcinoma.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 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 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •completely resected advanced high-risk RCC
- •T3b-c, T4, or N1-2, or M1 disease resected to no evidence of disease (AJCC-TNM, 2002) Patients must have recovered from any effects of surgery, which must have been - excellent performance status (Eastern Cooperative Oncology Group performance status of 0 or 1);
- •adequate organ function defined as WBC count 4,000/µL, platelet count 100,000/µL, hemoglobin 10 g/dL, serum creatinine 1.5 mg/dL or creatinine clearance 60 mL/min, and direct bilirubin 1.5 mg/dL; and forced expiratory volume at 1 second more than 2.0 L or 75% of predicted for height and age from pre-enrollment pulmonary function testing
- •age 18 years and older
排除标准
- •history or evidence of cardiac disease on ECG or autoimmunity
- •prior systemic treatment for RCC
- •history of invasive malignancy in the past 5 years or human immunodeficiency virus positivity
- •positive pregnancy test
研究组 & 干预措施
Study group: GM-CSF, IFN, IL-2
干预措施: GM-CSF, IFN alpha and IL-2 (Drug)
结局指标
主要结局
Disease-free survival (DFS)
时间窗: 3.5 years
次要结局
- Progression rate(28 months)
- Overall survival (OS)(5 years)
- Number of Participants with Adverse Events as a Measure of Safety and Tolerability(12 months)