NCT00060268已完成1 期
A Phase I/II Trial for Treatment of Obstructive Esophageal Tumors by Photodynamic Therapy (PDT) Using 2-(1-Hydroxyethyl)-2-Devinylpyropheophorbide-a (HPPH)
适应症
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 11
- 试验地点
- 2
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/II trial to study the effectiveness of photodynamic therapy with HPPH in treating patients who have obstructive esophageal tumors.
详细描述
OBJECTIVES:
- Determine, preliminarily, the safety of HPPH in patients with obstructive esophageal tumors undergoing photodynamic therapy.
- Determine, preliminarily, tumor response in patients treated with this drug.
- Determine the length of time for cutaneous photosensitivity at the various drug doses in these patients.
- Determine plasma clearance rates for this drug in these patients.
OUTLINE: This is a dose-escalation study.
- Phase I: Patients receive HPPH IV over 1 hour on day 1. Patients then undergo laser light therapy on day 2.
Cohorts of 3 patients receive escalating doses of HPPH and a single light dose until the optimal dose is determined. The optimal dose is defined as the minimum dose producing efficacy without unacceptable toxicity.
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
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
研究者
研究点 (2)
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