Phase I Safety Study of Clostridium Novyi-NT Spores in Patients With Treatment-Refractory Solid Tumor Malignancies
试验速览
- 阶段
- 1 期
- 状态
- 终止
- 入组人数
- 2
- 试验地点
- 1
- 主要终点
- To determine the safety profile, dose limiting toxicities (DLT), and maximum tolerated dose (MTD) of C. novyi-NT in humans with treatment-refractory solid tumor malignancies when given as a single intravenous injection
研究概览
简要总结
This study will include a one time intravenous (IV) infusion of Clostridium novyi-NT (C. novyi-NT) spores to treat solid tumors which have not responded to standard therapy.
详细描述
Investigators at the SKCCC have developed a bacterial strain (C. novyi-NT) that can infect tumors and destroy them, but does not grow in normal tissues. In animal experiments, a single intravenous injection of these bacteria can cause dramatic regression of many tumors, and the tumors do not recur in approximately (~) 30% of the animals.
This is a phase I dose escalation study using a single dose of Clostridium novyi-NT spores in patients with treatment-refractory solid tumor malignancies. The overall objective of this study is to determine the safety and document any preliminary evidence of anti-tumor activity in this patient population.
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 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- 未提供
排除标准
- 未提供
研究组 & 干预措施
Treatment arm
干预措施: Clostridium novyi-NT spores (Drug)
结局指标
主要结局
To determine the safety profile, dose limiting toxicities (DLT), and maximum tolerated dose (MTD) of C. novyi-NT in humans with treatment-refractory solid tumor malignancies when given as a single intravenous injection
时间窗: 2 years
次要结局
- To document preliminary evidence of anti-tumor activity of C. novyi-NT in humans with treatment-refractory solid tumor malignancies when given as a single intravenous injection(2 years)
- To analyze the pharmacokinetics of C. novyi-NT after administration to humans with treatment-refractory solid tumor malignancies when given as a single intravenous injection(2 years)
- To measure the host immune and inflammatory response to C. novyi-NT in humans with treatment-refractory solid tumor malignancies when given as a single intravenous injection(2 years)