Surgery and Intracavitary Photodynamic Therapy (PDT) for the Treatment of Malignant Pleural Mesothelioma; The Use of Light Delivery Fibers With Large Diffusers
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 12
- 试验地点
- 2
- 主要终点
- Feasibility
研究概览
简要总结
RATIONALE: Photodynamic therapy uses light and drugs that make cancer cells more sensitive to light to kill cancer cells. Combining photodynamic therapy with surgery may be an effective treatment for malignant mesothelioma.
PURPOSE: Phase II trial to study the effectiveness of combining photodynamic therapy with surgery in treating patients who have malignant mesothelioma.
详细描述
OBJECTIVES:
- Determine the feasibility of adjuvant photodynamic therapy with large diffuser fibers in patients with malignant mesothelioma undergoing surgery.
- Compare results of this regimen in these patients to historical controls.
- Determine the toxic effects of this regimen in these patients.
OUTLINE: This is a pilot study.
Patients receive porfimer sodium IV over 5-10 minutes on day 1. Patients undergo pleurectomy or pleuropneumonectomy followed by intracavitary photodynamic therapy on day 3.
Patients are followed at 1 month, every 4 months for 2 years, and then every 6 months for 3 years.
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
结局指标
主要结局
Feasibility
时间窗: 1 month, every 4 months for 2 years, and then every 6 months for 3 years
Toxic effects
时间窗: 1 month, every 4 months for 2 years, and then every 6 months for 3 years
Comparison of results from this regimen to historical controls
时间窗: At completion of study
次要结局
未报告次要终点