Renal Cell Carcinoma Treatment With Activated Tumor- Infiltrated Lymphocytes. A Non-Randomized Phase II Trial.
试验速览
- 阶段
- 2 期
- 状态
- 终止
- 发起方
- 入组人数
- 36
- 试验地点
- 2
- 主要终点
- Objective response rate: partial or complete response during at least 4 weeks from week 22 after the beginning of the first cycle of cytokines.
研究概览
简要总结
Renal cell carcinoma represents today 3% of the solid tumors of the adult. Their bad prognosis is due to the frequency of metastasis and the resistance to chemotherapy. Immunotherapy (interferon-α, interleukin-2) has shown some good results but an important toxicity. In our study, we evaluate the response to a new therapeutic strategy which combines an injection of patient's own activated lymphocytes to a classic immunotherapy with interferon-α and interleukin-2.
详细描述
Phase I and II trials for the treatment of melanoma or renal cell carcinoma have already evaluated lymphokine-activated killer cells and tumor-infiltrating cells. In metastatic renal cell carcinoma, these therapies have shown some complete responses and a low toxicity. In our study, we evaluate the response to a new therapeutic strategy which combines an injection of patient's own activated lymphocytes to a classic immunotherapy with interferon-α and interleukin-2. A secondary objective is to improve cell preparation methods and to characterize functionally and phenotypically injected cells.
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 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients aged between 18 and 70 years
- •Metastatic renal adenocarcinoma histologically proven
- •Karnofsky performance status ≥ 70%
- •Life expectation > 3 months
- •At least one target, in a non-irradiated area
- •Objective response or steady-state after a treatment with cytokines
- •Informed written consent
排除标准
- •Patients presenting more than one metastatic site with one hepatic metastasis diagnosed within the last 12 months
- •White blood cells count < 2.5 G/L, Platelet count < 100 G/L
- •Serum creatinine rate > 150 µmol/L
- •Positive serology for : hepatitis B, hepatitis C, retrovirus
- •Patient not available for a long-term follow-up
- •Bellini duct tumor
- •History of allograft or tumor within the five past years
- •Severe cardiovascular, hepatic, renal or pulmonary troubles
- •Auto-immune disease
- •Severe infection
- •Pregnancy or breast-feeding
- •Corticotherapy
结局指标
主要结局
Objective response rate: partial or complete response during at least 4 weeks from week 22 after the beginning of the first cycle of cytokines.
次要结局
- - Disease free survival
- - Overall survival
- - Functional and phenotypic characteristics of injected cells
- - Biological response