NCT03133650进行中（未招募）1 期
A Phase I Trial of Vascular-Targeted Photodynamic Therapy in Esophagogastric Cancer Patients With Moderate to Severe Dysphagia
适应症
干预措施
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 12
- 试验地点
- 3
- 主要终点
- Maximum tolerated laser fluence rate
研究概览
简要总结
The purpose of this study is to establish the highest dose of laser light for WST-11 VTP to treat obstruction from esophageal cancer that can be safely given.
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
- •Age 18 or older
- •Confirmed tissue diagnosis of esophageal squamous cell cancer, adenocarcinoma or poorly differentiated carcinoma, with pathology reviewed at MSKCC
- •Has incurable disease defined as at least one of the following:
- •Presence of metastases to other organs (Stage IV), now or previously
- •Has locally advanced disease and are not candidates for surgery or more radiation treatment
- •Has received the maximal radiation therapy to the primary site, or has been assessed by radiation oncology as not being a candidate for chemoradiation therapy.
- •Karnofsky performance status >/= 50%
- •No endoluminal stent in place at the time of treatment
- •Previous esophageal dilation is permitted, provided the patient has developed recurrent dysphagia since that procedure
- •Patients should not have received any systemic therapy (including chemotherapy, biologic therapy or immunotherapy) </= 7 days prior to treatment
- •Prior radiation or surgery to the esophagus is permitted for patients with locally recurrent/persistent disease
- •Patients on prophylactic or full-dose anticoagulation are eligible, provided the treating physician believes it is safe to temporarily withhold anticoagulation (see Section 9.2)
- •Adequate organ function defined at baseline as:
- •ANC ≥1,000/ L
- •Platelets ≥75,000/ L
- •Hb ≥8.5 g/dl
- •INR ≤1.5 (except for patients who are on full-dose warfarin)
- •Calculated creatinine clearance ≥50 ml/min (using Cockcroft-Gault method)
- •Total serum bilirubin ≤1.5 mg/dL, or </= 2.5 mg/dL for patients with a known history of Gilbert's syndrome
- •AST/ALT ≤5× upper limit of normal
- •Able to provide written informed consent
排除标准
- •Pregnant or breast-feeding women. Women of childbearing potential (WOCBP) must undergo a negative pregnancy test (either serum or urine) prior to study entry. Both sexes must use contraception while on study. WOCBP include:
- •Any woman who has experienced menarche and who has not undergone surgical sterilization (hysterectomy, bilateral tubal ligation or oophorectomy) or who is not post-menopausal (defined as amenorrheic ≥12 consecutive months)
- •Women on hormone replacement therapy with documented serum follicle stimulating hormone level > 35 mIU/ml
- •Women who are using oral, implanted or injectable contraceptive hormones or mechanical products such as intrauterine device or barrier methods to prevent pregnancy or are practicing abstinence of where the partner is sterile
- •T4 tumors with involvement of any adjacent structure, including the trachea, aorta or pleura
- •Prior history of esophageal perforation
- •Any other medical or psychiatric comorbidities, including decompensated heart failure, unstable angina or coronary artery disease or severe pulmonary disease, that, in the opinion of the study investigator, would make the patient a poor candidate for the study
研究组 & 干预措施
Vascular-targeted photodynamic therapy (VTP) using WST11
Experimental
Participants will receive intravenous administration of WST11 at a dose of 4 mg/kg, infused over 10 minutes, during an endoscopy procedure, followed by immediate laser light application.
干预措施: WST 11-mediated VTP therapy (Drug)
结局指标
主要结局
Maximum tolerated laser fluence rate
时间窗: 60 days
The maximally tolerated laser light fluence rate (mW/cm) of light exposure for VTP of malignant obstruction due to esophagogastric cancer will be measured by examining 6 fluence rates beginning with a fluence rate of 150 nW/cm, then increasing by 50mW/cm, up to a maximum of 400 mW/cm (150, 200, 250 300, 350, 400).
次要结局
未报告次要终点
研究者
研究点 (3)
Loading locations...
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