Sequential Administration of Cryoablation and Cyclophosphamide for Advanced Solid Epithelial Cancer
试验速览
- 阶段
- 早期 1 期
- 状态
- 终止
- 入组人数
- 19
- 试验地点
- 1
- 主要终点
- Safety, in terms of absences of severe adverse events (SAE) and unacceptable toxicity
研究概览
简要总结
RATIONALE: Drugs used in chemotherapy, such as cyclophosphamide, work in different ways to stop the growth of cancer cells, either by killing the cells or by stopping them from dividing. Cryoablation kills cancer cells by freezing them. Giving chemotherapy together with cryoablation may kill more cancer cells.
PURPOSE: This clinical trial is studying how well giving cyclophosphamide together with cryoablation works in treating patients with advanced or metastatic epithelial cancer.
详细描述
OBJECTIVES:
- Document radiologic and/or tumor marker response to cryotherapy of tumor lesions followed by cyclophosphamide.
OUTLINE: This is a pilot study.
Patients undergo percutaneous biopsy of the targeted lesion prior to cryoablation. Patients then undergo percutaneous or open cryotherapy of the largest or most accessible lesion on day 0. On day 3, patients receive cyclophosphamide IV over 1 hour.
Tumor markers (if applicable) are assessed at baseline and monthly during study until marker progression.
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 120 Years（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
Intervention
Participant will receive one time intravenous infusion of cyclophosphamide three days after scheduled cryoablation surgery.
干预措施: cyclophosphamide (Drug)
Intervention
Participant will receive one time intravenous infusion of cyclophosphamide three days after scheduled cryoablation surgery.
干预措施: Cryoablation (Device)
结局指标
主要结局
Safety, in terms of absences of severe adverse events (SAE) and unacceptable toxicity
时间窗: Two years
次要结局
- Tumor response, according to RECIST criteria(Two years)