A Phase II Study of Photodynamic Therapy (PDT) Using 2-[1-hexyloxyethyl]-2 Devinyl Pyropheophorbide-a (HPPH) for Treatment of Advanced Obstructing Endobronchial Lung Cancer
试验速览
- 阶段
- 2 期
- 状态
- 终止
- 入组人数
- 6
- 试验地点
- 1
- 主要终点
- Tumor Response
研究概览
简要总结
RATIONALE: Photodynamic therapy uses a drug, such as HPPH, that becomes active when it is exposed to a certain kind of light. When the drug is active, tumor cells are killed. This may be an effective treatment for advanced non-small cell lung cancer that blocks the air passages.
PURPOSE: This phase II trial is studying how well photodynamic therapy using HPPH works in treating patients with advanced non-small cell lung cancer that blocks the air passages.
详细描述
OBJECTIVES:
Primary
- To determine the efficacy of photodynamic therapy (PDT) using HPPH in patients with advanced obstructing endobronchial non-small cell lung cancer.
Secondary
- To determine palliation of symptoms in patients treated with this regimen.
- To determine the amount of HPPH taken up by the obstructing endobronchial tumors in these patients.
- To determine the extent of STAT3 cross-links, which are molecular markers of immediate PDT reaction, in the obstructing tumors of these patients before and after PDT treatment.
- To determine inflammation and apoptosis in the obstructing bronchial tumors of these patients before and after PDT treatment.
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
HPPH
Patients will receive 4 mg/m2 HPPH (given light exposure precautions) and approximately 2 days later be treated endoscopically with 150J/cm of 665 +-5nm light.
干预措施: HPPH (Drug)
HPPH
Patients will receive 4 mg/m2 HPPH (given light exposure precautions) and approximately 2 days later be treated endoscopically with 150J/cm of 665 +-5nm light.
干预措施: endoscopic procedure (Procedure)
结局指标
主要结局
Tumor Response
时间窗: 6 months
次要结局
- STAT3 Cross-links as Assessed by Western Blotting(2 months)
- Inflammation and Apoptosis as Assessed by Immunohistochemistry(2 months)
- Palliation of Symptoms as Assessed by the Pulmonary Symptom Scale(2 months)
- Photosensitizer (HPPH) Concentration in Tumor(2 months)