NCT00862303Unknown1 期
Study of Autologous Dendritic Cells (DC) Loaded With Autologous Tumor Lysate (DC-Vaccine) in Combination With Cytokine-Induced Killer Cell (CIK) in Patients With Renal Cell Cancer
适应症
干预措施
相关药物
试验速览
- 阶段
- 1 期
- 入组人数
- 100
- 试验地点
- 1
- 主要终点
- Objective tumor response (complete and partial response), Time to recurrence (TTR), Progression-free(PFS) and overall survival(OS) as measured by RECIST criteria.
研究概览
简要总结
The purpose of this study is to show if vaccination with autologous dendritic cells pulsed with tumor lysate in combination with Cytokine-Induced Killer Cell (CIK) can induce a measurable immune response in patients with renal cell carcinoma, and to evaluate the clinical effect of the regimen.
详细描述
The purpose of this study is to show if vaccination with autologous dendritic cells pulsed with tumor lysate in combination with Cytokine-Induced Killer Cell (CIK) can induce a measurable immune response in patients with renal cell carcinoma, and to evaluate the clinical effect of the regime.
Primary
- Determine the clinical responses(objective response, progression-free survival, and overall survival) in patients with renal cell carcinoma treated with autologous dendritic cells (DC) loaded with autologous tumor lysate (DC vaccine) in combination with Cytokine-Induced Killer Cell (CIK).
Secondary
- Determine cellular immune response response in terms of immuknow assay, and correlate immune response with objective clinical response in patients treated with this regimen.
- Determine safety of multiple administrations of this regimens in these patients.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 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
- •Histologically proven renal cell carcinoma
- •Age: > 18
- •WHO- ECOG Performance Status 0-1
- •At least one measurable tumor lesions according to the RECIST criteria.
- •Life expectancy more than 3 months
- •Written informed consent
排除标准
- •Patients with a history of any other neoplastic disease less than 5 years ago (excepting treated carcinomas in situ of the cervix and basal/squamous cell carcinomas of the skin).
- •Patients with metastatic disease in the central nervous system (CNS).
- •Patients with other significant illness including severe allergy, asthma, angina pectoris or congestive heart failure.
- •Patients with acute or chronic infection including HIV.
- •Patients who are pregnant or nursing.
- •Patients who have received antineoplastic therapy including chemotherapy or immunotherapy less than 4 weeks before beginning the trial.
- •Patients who receive corticosteroids or other immunosuppressive agents.
- •Patients with active autoimmune diseases such as lupus erythematosus, rheumatoid arthritis or thyroiditis.
研究组 & 干预措施
IL-2/IFN-α
Placebo Comparator
干预措施: IL-2/IFN-α (Drug)
DC-CIK
Experimental
干预措施: DC-CIK (Biological)
结局指标
主要结局
Objective tumor response (complete and partial response), Time to recurrence (TTR), Progression-free(PFS) and overall survival(OS) as measured by RECIST criteria.
时间窗: every 3 months
次要结局
- Immunity as measured by T-cell functionality (immuknow assay )to the tumor. Safety as measured by NCI common toxicity table （CTC） at completion of study.(at screening, baseline, weeks 4 , 12 and years 1 after first vaccination, and at completion of study treatment)
研究者
研究点 (1)
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