Immunobiology of Photodynamic Therapy in Lung Cancer Patients
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 35
- 试验地点
- 1
- 主要终点
- Determine the cytokine phenotype found in collected specimens of lung cancer patients treated with photodynamic therapy.
研究概览
简要总结
RATIONALE: Photodynamic therapy uses a drug that becomes active when it is exposed to a certain kind of light. When the drug is active, cancer cells are killed. This may be effective against non-small cell lung cancer.
PURPOSE: This clinical trial is studying how well photodynamic therapy using porfimer sodium works in treating patients with non-small cell lung cancer and bronchial disease.
详细描述
OBJECTIVES:
Primary
- To test the hypothesis that the immune response in non-small cell lung cancer patients treated with photodynamic therapy (PDT) is T cell mediated.
Secondary
- To test the hypothesis that PDT potentially affects survival rates in these patients.
- To test the hypothesis that T lymphocytes mediate an immune response that affects survival in PDT treated patients.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Control
- 时间视角
- Retrospective
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
- •Patients that have a diagnosis of non-small cell lung cancer, of any stage, with obstructive or hemorrhagic endobronchial disease receiving PDT treatment.
排除标准
- •Patients that have undergone PDT, chemotherapy or radiation therapy within the past 3 months will not be considered for enrollment.
- •Patients taking antioxidant therapy will be excluded from enrollment due to potential interaction with the potential oxidative mechanism of action of Photofrin®. These antioxidants would include beta-carotene, lutein, Lycopene, Selenium, Vitamin A, Vitamin C, Vitamin E.
研究组 & 干预措施
Group 1
Patients receive porfimer sodium IV over 3-5 minutes and undergo irradiation with red light 48 hours later. Patients receive 2 more treatments at 2-day intervals.
干预措施: porfimer sodium (Drug)
Group 1
Patients receive porfimer sodium IV over 3-5 minutes and undergo irradiation with red light 48 hours later. Patients receive 2 more treatments at 2-day intervals.
干预措施: bronchoscopy (Procedure)
结局指标
主要结局
Determine the cytokine phenotype found in collected specimens of lung cancer patients treated with photodynamic therapy.
时间窗: up to one year
Tumor tissue, broncheoalveolar fluid and blood from enrolled patients will be assayed for the presence of the following defined lymphocyte phenotypes
次要结局
- Correlate the cytokine phenotype of patients undergoing PDT treatment with survival(up to one year)
研究者
Susan Moffatt-Bruce
Principal Investigator
Ohio State University Comprehensive Cancer Center