NCT00109655Unknown1 期
A Phase 1 Dose-Escalation Trial of Intravesical CG0070 for Superficial Transitional Cell Carcinoma of the Bladder After Bacillus Calmette-Guerin Failure
Cell Genesys19 个研究点 分布在 2 个国家目标入组 75 人开始时间: 2005年4月1日最近更新:
适应症
试验速览
- 阶段
- 1 期
- 发起方
- 入组人数
- 75
- 试验地点
- 19
- 主要终点
- Maximum-tolerated or maximum feasible dose in single and multidose regimens of CG0070 by intravesical administration
研究概览
简要总结
The main purpose of this research study is to evaluate the safety and dosing of CG0070.
详细描述
Cohorts of three to six patients will be assigned to receive intravesical (into the bladder) administration of CG0070 either Weekly or Every 4 Weeks for up to a total of 6 doses.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non 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
- •High grade non-muscle invasive bladder cancer (stages Ta, T1 and/or CIS - carcinoma in situ). High grade being defined as G2 or G3 disease.
- •Failure of at least one prior treatment with BCG, defined as evidence of TCC on cystoscopic exam and biopsy or cystoscopic exam and urine cytology at least 6 weeks from last BCG treatment
- •ECOG performance status 0-1
- •Adequate bone marrow, renal, liver and coagulation function
排除标准
- •Pregnant or nursing
- •HIV positive
- •Use of anticoagulants such as coumadin or heparin
- •History of bleeding disorder
- •Active systemic autoimmune disease or chronic immunodeficiency
- •Prior gene therapy
- •Uncontrolled cystitis, bladder pain, bladder spasms, urinary incontinence, or reduced bladder volume
结局指标
主要结局
Maximum-tolerated or maximum feasible dose in single and multidose regimens of CG0070 by intravesical administration
时间窗: Study End
次要结局
- Assessment of the amount of CG0070 in the urine and blood over time by PCR(Study End)
研究者
研究点 (19)
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