NCT01238042已完成1 期
A Pilot Study To Determine The Maximum Range of Light Doses At Two HPPH Doses With Acceptable Normal Tissue Toxicity For PDT Treatment Of High Grade Dysplasia,CIS or 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
- Optimal Light Dose
研究概览
简要总结
Patient's with High Grade Dysplasia, Carcinoma in situ or Early Adenocarcinoma in Barrett's Esophagus are injected with HPPH and one day later are endoscopically treated with light from a laser.
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 (HGD/CIS or early adenocarcinoma) can be primary or recurrent, Stage 0 or I N0M (any)
- •Patients must have no contraindication 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.
- •Patients with early invasive adenocarcinoma will be included only if they are considered poor surgical risks, have failed or refused XRT/chemo, or refused surgery.
- •If the patients has had cancer other than non-melanoma skin cancer, their treating physician must deem them disease-free.
排除标准
- •Patients with tumors of grade greater than T-
- •Porphyria or hypersensitivity to porphyrin or porphyrin-like compounds
- •WBC<4000; platelet count<100,000; prothrombin times 1.5 times above 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.
研究组 & 干预措施
Light Dose Escalation
Experimental
Light Dose escalated from 150 joules/cm to 200 joules/cm
干预措施: HPPH (Drug)
结局指标
主要结局
Optimal Light Dose
时间窗: 24 hours
Using toxicity to normal surrounding tissue as a determinant and using two HPPH doses of PDT in HGD, CIS or early adenocarcinoma in Barrett's esophagus, to determine the optimal light dose at each HPPH dose
次要结局
- Toxicity to normal surrounding tissue(24 hours)
- Comparing HPPH to Photofrin(5 years)
- Effect of injection(24 hours)
- Efficacy of Treatment(5 years)
- Resolve Barrett's mucosa(5 years)
研究者
研究点 (1)
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