A Phase I Study of Photodynamic Therapy (PDT) Using 2-(1-hexyloxyethyl)-2 Devinyl Pyropheophorbide-a (HPPH) for Treatment of Early Stage Lung Cancer - A Dose Ranging Study
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 试验地点
- 1
研究概览
简要总结
RATIONALE: Photodynamic therapy uses light and drugs that make tumor cells more sensitive to light to kill tumor cells. Photosensitizing drugs such as HPPH are absorbed by tumor cells and, when exposed to light, become active and kill the tumor cells.
PURPOSE: Phase I trial to study the effectiveness of photodynamic therapy with HPPH in treating patients who have non-small cell lung cancer.
详细描述
OBJECTIVES:
- Determine the systemic and normal tissue toxicity of photodynamic therapy with HPPH in patients with early stage or centrally obstructing non-small cell lung cancer.
- Determine, preliminarily, the efficacy of this regimen in these patients.
OUTLINE: This is a dose-escalation study of HPPH.
Patients receive HPPH IV over 1 hour on day 1. Patients undergo laser light therapy via bronchoscopy on day 3.
Cohorts of 3-6 patients receive escalating doses of HPPH until the maximum tolerated dose (MTD) is determined. The MTD is defined as the dose preceding that at which 2 of 3 or 2 of 6 patients experience dose-limiting toxicity.
研究设计
- 研究类型
- Interventional
- 主要目的
- Treatment
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 confirmed microinvasive or centrally obstructing non-small cell lung cancer
- •Squamous cell carcinoma
- •Adenocarcinoma
- •Large cell carcinoma
- •PATIENT CHARACTERISTICS:
- •18 and over
- •Performance status:
- •Karnofsky 50-100% OR
- •Life expectancy:
- •Not specified
- •Hematopoietic:
- •WBC at least 2,000/mm^3
- •Platelet count at least 50,000/mm^3
- •Bilirubin no greater than 3.0 mg/dL
- •Alkaline phosphatase no greater than 3 times upper limit of normal (ULN)
- •SGOT no greater than 3 times ULN
- •PT no greater than 1.5 times ULN
- •Creatinine no greater than 3.0 mg/dL
- •No severe chronic obstructive pulmonary disease that would preclude study
- •Not pregnant
- •Fertile patients must use effective contraception
- •No contraindications to bronchoscopy
- •No porphyria
- •No hypersensitivity to porphyrin or porphyrin-like compounds
- •PRIOR CONCURRENT THERAPY:
- •Biologic therapy:
- •Prior biologic therapy for lung cancer allowed
- •Chemotherapy:
- •At least 4 weeks since prior chemotherapy
- •No concurrent chemotherapy
- •Endocrine therapy:
- •Prior endocrine therapy for lung cancer allowed
- •Radiotherapy:
- •At least 4 weeks since prior radiotherapy
- •No concurrent external beam radiotherapy
- •No concurrent surgery
- •Prior therapy for lung cancer allowed
排除标准
- 未提供