DC Vaccine Therapy Combined With Cytokine-Induced Killer Cell in Treating Patients With Renal Cell Carcinoma
2011年3月7日 更新者：Fuzhou General Hospital
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
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.
研究概览
详细说明
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
1. 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.
研究类型
介入性
注册 (预期的)
100
阶段
- 阶段2
- 阶段1
联系人和位置
本节提供了进行研究的人员的详细联系信息，以及有关进行该研究的地点的信息。
学习联系方式
- 姓名：Jianming Tan, Professor
- 电话号码：008613375918000
- 邮箱：TANJM156@YAHOO.COM.CN
学习地点
-
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Fujian
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Fuzhou、Fujian、中国、350025
- 招聘中
- Fuzhou General Hospital
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接触：
- Jianming Tan, M.D and Ph.D
- 电话号码：008613375918000
- 邮箱：TANJM156@YAHOO.COM.CN
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参与标准
研究人员寻找符合特定描述的人，称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。
资格标准
适合学习的年龄
18年 及以上 (成人、年长者)
接受健康志愿者
不
有资格学习的性别
全部
描述
Inclusion Criteria:
- 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
Exclusion Criteria:
- 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.
学习计划
本节提供研究计划的详细信息，包括研究的设计方式和研究的衡量标准。
研究是如何设计的？
设计细节
- 主要用途：治疗
- 分配：随机化
- 介入模型：并行分配
- 屏蔽：无（打开标签）
武器和干预
参与者组/臂 |
干预/治疗 |
|---|---|
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实验性的：DC-CIK
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Patients receive autologous dendritic cells (DC) loaded with autologous tumor lysate (DC vaccine) by endermic injection and infusion of CIK cells.
其他名称：
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安慰剂比较：IL-2/IFN-α
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Patients receive treatment of IL-2 or IFN-α.
其他名称：
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研究衡量的是什么？
主要结果指标
结果测量 |
大体时间 |
|---|---|
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Objective tumor response (complete and partial response), Time to recurrence (TTR), Progression-free(PFS) and overall survival(OS) as measured by RECIST criteria.
大体时间：every 3 months
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every 3 months
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次要结果测量
结果测量 |
大体时间 |
|---|---|
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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.
大体时间：at screening, baseline, weeks 4 , 12 and years 1 after first vaccination, and at completion of study treatment
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at screening, baseline, weeks 4 , 12 and years 1 after first vaccination, and at completion of study treatment
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合作者和调查者
在这里您可以找到参与这项研究的人员和组织。
调查人员
- 首席研究员：Jianming Tan, M.D.、Fuzhou General Hospital
研究记录日期
这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查，以确保它们在发布到公共网站之前符合特定的质量控制标准。
研究主要日期
学习开始
2009年3月1日
初级完成 (预期的)
2015年6月1日
研究完成 (预期的)
2015年12月1日
研究注册日期
首次提交
2009年3月13日
首先提交符合 QC 标准的
2009年3月13日
首次发布 (估计)
2009年3月16日
研究记录更新
最后更新发布 (估计)
2011年3月8日
上次提交的符合 QC 标准的更新
2011年3月7日
最后验证
2009年3月1日
更多信息
此信息直接从 clinicaltrials.gov 网站检索，没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求，请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改，我们的网站上也会自动更新.
IL-2/IFN-α的临床试验
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