NCT01236443已完成1 期
A Phase I/II Study of Photodynamic Therapy (PDT) Using 2-[1-hexyloxyethyl]-2-devinylpyropheophorbide-a (HPPH) for the Treatment of High Grade Dysplasia, Carcinoma-in-situ and Early Adenocarcinoma in Barrett's Esophagus
适应症
干预措施
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 18
- 试验地点
- 1
- 主要终点
- Toxicity of HPPH at different doses
研究概览
简要总结
A Study to identify toxicity and optimal photodynamic treatment parameters using the photosensitizer 2-[1-hydroxyethyl]-2-devinylpyropheophorbide-a (HPPH) in high grade dysplasia, carcinoma-in-situ, or early adenocarcinoma in Barrett's esophagus.
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
- •Patient must have biopsy proven high-grade (severe) dysplasia, carcinoma-in-situ or early stage adenocarcinoma;
- •Patient may have received prior therapy; e.g. Nd-YAG laser, radiation therapy or chemotherapy. At least one month must have elapsed between prior treatments and PDT.
- •Tumors can be primary or recurrent, Stage 0 or I, N0M (any).
- •Patients must have no contraindications to endoscopy.
- •Male or female patients must be 18 years old or older. Female patients must not be pregnant and must be practicing a medically acceptable form of birth control or be sterile or post-menopausal. A pregnancy test is required and must be negative.
- •Patients must sign an Informed Consent according to FDA guidelines and be acceptable to the RPCI IRB.
- •Patients must have a Karnofsky status 50 or above.
- •Operable patients are not excluded.
排除标准
- •Patients with tumors of grade greater than T-
- •Porphyria or hypersensitivity to porphyrin or porphyrin-like compounds.
- •WBC <2,000; platelet count <50,000, prothrombin time 1.5 times above the upper normal limit.
- •Patients with impaired renal and/or hepatic function (total serum bilirubin >3.0 mg/d, serum creatinine >3 mg%, alkaline phosphatase (hepatic) or SGOT >3 times the upper normal limit.
- •Patients on concurrent chemotherapy or radiation therapy will be excluded as well as those having received prior treatment for the esophageal cancer within 4 weeks of enrollment.
- •If the patient has cancer other than non-melanoma skin cancer they must be deemed disease free by their treating physician.
研究组 & 干预措施
HPPH
Experimental
3 mg/m2
干预措施: HPPH (Drug)
结局指标
主要结局
Toxicity of HPPH at different doses
时间窗: 2 days
次要结局
- Determine optimal PDT parameters using HPPH in HGD, CIS and Barrett's esophagus(length of study)
研究者
研究点 (1)
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