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
- 1
- 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
- •DISEASE CHARACTERISTICS:
- •Histologically or cytologically confirmed malignant mesothelioma, including the following cell types:
- •Mixed mesothelial
- •Sarcomatous
- •Stage I or II disease using the Butchart system as determined by CT scan or MRI
- •Disease confined to 1 hemithorax
- •No tumor involvement of esophagus or heart as evidenced by CT scan
- •Pericardial or diaphragmatic involvement allowed if disease is limited to the ipsilateral chest
- •N2 disease allowed if no contralateral pleural involvement
- •No adenocarcinoma or nonmesothelioma sarcoma of the chest wall
- •PATIENT CHARACTERISTICS:
- •18 and over
- •Performance status
- •Life expectancy
- •Not specified
- •Hematopoietic
- •WBC greater than 4,000/mm^3
- •Platelet count greater than 100,000/mm^3
- •Hemoglobin greater than 8.5 g/dL (transfusion allowed)
- •Bilirubin less than 3.0 mg/dL
- •Alkaline phosphatase less than 2 times upper limit of normal (ULN)
- •SGOT less than 2 times ULN
- •Creatinine less than 3.0 mg/dL
- •Cardiovascular
- •No myocardial infarction within the past 6 months
- •Arterial partial pressure of carbon dioxide (pCO_2) less than 50 torr at rest
- •Predicted postoperative FEV_1 at least 800 mL with maximum oxygen consumption/kg at least 15 mL/min
- •Predicted postoperative total lung capacity at least 40% of hemoglobin and alveolar ventilation
- •Not pregnant
- •No other concurrent malignancy except nonmelanoma skin cancer
- •No contraindication to general anesthetic
- •No history of porphyria
- •No indicated sensitivity to porfimer sodium
- •PRIOR CONCURRENT THERAPY:
- •Biologic therapy
- •Not specified
- •Chemotherapy
- •More than 30 days since prior chemotherapy
- •Endocrine therapy
- •Not specified
- •Radiotherapy
- •No prior radiotherapy to the chest
- •No prior radiotherapy for mesothelioma
- •Not specified
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
Comparison of results from this regimen to historical controls
时间窗: At completion of study
Toxic effects
时间窗: 1 month, every 4 months for 2 years, and then every 6 months for 3 years
次要结局
未报告次要终点