A Phase I/II Evaluation of Cytokine Induced Killer Cells Stimulated by DC(DCIK) Immunotherapy in Patients With Renal Cell Carcinoma
试验速览
- 阶段
- 1 期
- 发起方
- 入组人数
- 30
- 试验地点
- 1
- 主要终点
- overall survival
研究概览
简要总结
30% of renal cell carcinoma patients have metastases, mostly in lung, liver and bones at the time of diagnosis. Because of poor response to radiation therapy or chemotherapy, several studies have been initiated to find alternative therapeutic options.
Cytokine induced killer cells(CIK) are an unique population of cytotoxic T lymphocytes with a characteristic CD3+ CD56+ phenotype; they can be generated from cytokine cocktail-induced peripheral blood mononuclear cells (PBMC). CIK cells represent strong anti-tumor cytotoxicity in vitro and in vivo. Interestingly,the anti-tumor activity of CIK cells can be enhanced by incubation with dendritic cells (DC), which are the most potent antigen (Ag)-presenting cells.
The purpose of this study was to evaluate the clinical efficacy of DC-activated CIK cell treatment following regular therapy and the effects of this therapy on immune responses in patients with renal cell carcinoma after surgery.
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 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Female or male, adult patients of 18 to 75 years of age at time of diagnosis that qualify for standard treatment including surgery.
- •Histologically confirmed diagnosis of renal cell carcinoma.
- •Newly diagnosed or recurrent disease.
- •Karnofsky performance status 60-
- •Life expectancy ≥ 12 weeks.
- •Written informed consent of patient and/or legal guardian.
- •Must be off steroid at least two weeks prior to vaccination.
- •Hematologic and metabolic panel results will be within the parameters of the protocol.
- •Normal renal function in the kidney.
- •Adequate function of liver,lung and heart.
- •Negative pregnancy test
- •Fertile patients must use effective contraception
- •Serologically negative for HIV,HBV,HCV.
- •Syphilis serology negative
- •Patient must have no prior sensitivity to the components of the dendritic cell vaccine.
排除标准
- •Anti-neoplastic chemotherapy or radiotherapy during 4 weeks before entering the study.
- •Presence of acute infection.
- •Inability to obtain informed consent because of psychiatric or complicating medical problems.
- •Patients with other significant illness including severe allergy, asthma, angina pectoris or congestive heart failure.
- •Subjects with organ allografts.
- •Known history of autoimmune disorder.
- •Pregnancy or breast-feeding.
- •Positive for hepatitis B, C, HIV, syphilis.
- •Patients unwilling to perform a save method of birth control.
结局指标
主要结局
overall survival
时间窗: 1 year
次要结局
- Objective tumor response, Time to recurrence, Progression-free, Cellular immunity.(1 year)