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
- 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/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
- •DISEASE CHARACTERISTICS:
- •Histologically confirmed esophageal cancer
- •Stages T1-T3, any N, any M
- •Tumor partially or completely obstructing the esophagus
- •Primary or recurrent tumor meeting 1 of the following criteria for treatment:
- •Patient is too debilitated for or refused conventional therapy
- •Recurred after or failed to respond to chemotherapy, radiotherapy, or surgery
- •Deemed most appropriately treated by photodynamic therapy (PDT) in the opinion of the physician
- •Persistent symptomatic disease required in patients who received prior radiotherapy, chemotherapy, or PDT with photofrin or HPPH
- •Prior PDT with HPPH allowed only if tumor is evident outside of the original treatment site
- •No tracheal or bronchial involvement by bronchoscopy
- •No T4 lesions involving the aorta, lung, or pericardium by CT scan, MRI, or endoscopic ultrasonography
- •PATIENT CHARACTERISTICS:
- •18 and over
- •Performance status
- •Not specified
- •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
- •Not pregnant
- •Negative pregnancy test
- •Fertile patients must use effective contraception
- •No contraindications to endoscopy
- •No porphyria
- •No hypersensitivity to porphyrins
- •PRIOR CONCURRENT THERAPY:
- •Biologic therapy
- •Not specified
- •Chemotherapy
- •See Disease Characteristics
- •More than 4 weeks since prior chemotherapy
- •No concurrent chemotherapy
- •Endocrine therapy
- •Not specified
- •Radiotherapy
- •See Disease Characteristics
- •More than 4 weeks since prior radiotherapy
- •No concurrent radiotherapy
- •Not specified
- •No concurrent photosensitizing agents (e.g., tetracyclines, sulfonamides, phenothiazines, sulfonylureas, hypoglycemic agents, thiazide diuretics, and griseofulvin)
排除标准
- 未提供
研究者
研究点 (1)
Loading locations...
相似试验
已完成
1 期
Photodynamic Therapy With HPPH in Treating Patients With Non-Small Cell Lung CancerLung CancerNCT00025571Roswell Park Cancer Institute
已完成
1 期
Photodynamic Therapy in Treating Patients With Stage III or Stage IV MelanomaMelanoma (Skin)NCT00007969QLT Inc.
已完成
1 期
Photodynamic Therapy Plus Brachytherapy in Treating Patients With Lung CancerLung CancerNCT00014066Roswell Park Cancer Institute
已完成
2 期
Photodynamic Therapy in Treating Patients With Cancer of the Bile Duct, Gallbladder, or PancreasExtrahepatic Bile Duct CancerGallbladder CancerPancreatic CancerLiver CancerNCT00003923Memorial Sloan Kettering Cancer Center4
已完成
1 期
Photodynamic Therapy in Treating Patients With Basal Cell Skin CancerNon-melanomatous Skin CancerNCT00017485Roswell Park Cancer Institute6