NCT00087984已完成1 期
A Phase I/II Study To Examine The Safety, Feasibility, Immunological Response, And Measures Of Clinical Antitumor Activity After Administering Unselected, Autologous, Amplified Tumor Total RNA-Transfected, Dendritic Cell Vaccine (MB-002) To Patients With Metastatic Renal Cell Carcinoma
Argos Therapeutics8 个研究点 分布在 2 个国家目标入组 26 人开始时间: 2004年1月1日最近更新:
适应症
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- 入组人数
- 26
- 试验地点
- 8
- 主要终点
- To examine the safety of multiple administrations of MB-002 in patients with newly diagnosed, metastatic renal cell carcinoma.
研究概览
简要总结
The purpose of this trial is to examine the safety, feasibility, immunological response, and clinical antitumor activity of administering a dendritic cell vaccine to patients with metastatic 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 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Have a new diagnosis of metastatic renal cell carcinoma;
- •Must be at least 18 years or older;
- •Have a scheduled unilateral nephrectomy;
- •ECOG of 0 or 1;
- •Free of brain metastases by CT or MRI;
- •Normal renal function in contralateral kidney;
- •Male or non-pregnant/non-lactating female on appropriate birth control methods while on study;
- •Clinically acceptable screening results.
- •No immunosuppressive therapy not limited to corticosteroids (including topical steroids or steroid containing inhalers), azathioprine cyclosporine two months prior to study entry;
- •No active autoimmune disease
排除标准
- 未提供
结局指标
主要结局
To examine the safety of multiple administrations of MB-002 in patients with newly diagnosed, metastatic renal cell carcinoma.
时间窗: From registration until disease progression or withdrawal from study
To measure clinical antitumor activity including objective tumor response and an estimate of time to tumor progression (or progression-free interval).
时间窗: From registration until disease progression or withdrawal from study
次要结局
未报告次要终点
研究者
研究点 (8)
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