Phase I Study of WST11 Phototherapy for Upper Tract Urothelial Carcinoma
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 30
- 试验地点
- 1
- 主要终点
- Maximum tolerated laser fluence rate
研究概览
简要总结
The purpose of this study is to test the safety of a combination of the study drug called WST11 and PDT. Photodynamic therapy (PDT) is a type of ablation therapy (treatment which destroys tumor cells) which has been previously approved for the treatment of patients with other cancers. It works by using a drug that is given through the vein and then is activated in the tumor by light administered during endoscopy, which results in destruction of the cancer cells.
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 urothelial carcinoma involving the ureter and/or renal pelvis with pathology reviewed at MSKCC
- •Residual or recurrent cancer following prior endoscopic treatment
- •Ineligible, unwilling or refusing to undergo surgical management by resection of involved kidney or ureter.
- •Karnofsky performance status ≥ 50%
- •Patients with existing ureteral obstruction and/or existing ureteral stent will be permitted. Demonstration of the site and degree of obstruction must be documented by retrograde pyelography at the time of initial and follow up endoscopic procedures within 60 days.
- •Patients should not have received any systemic therapy (including chemotherapy, biologic therapy or immunotherapy) ≤4 weeks prior to treatment
- •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/ µL
- •Platelets ≥75,000/ µL
- •Hb ≥9 g/dl
- •INR ≤1.5 (except for patients who are on full-dose warfarin)
- •Calculated creatinine clearance ≥40 ml/min (using Cockcroft-Gault method)
- •Total serum bilirubin ≤1.5 mg/dL
- •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 or where the partner is sterile
- •T4 tumors with involvement of the bowel or major blood vessels • 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
phototherapy with WST11
Patients with urothelial cancer that includes involvement of the upper urinary tract and have failed prior endoscopic treatment, refuse standard treatment, or are ineligible for curative surgical resection of the kidney or ureter will be offered WST11 VTP treatment to be provided at the time of scheduled endoscopic procedure. At the time of endoscopy, patients will be treated with VTP therapy applied to the site of the tumor.
干预措施: WST11 mediated vascular targeted phototherapy (VTP) (Drug)
phototherapy with WST11
Patients with urothelial cancer that includes involvement of the upper urinary tract and have failed prior endoscopic treatment, refuse standard treatment, or are ineligible for curative surgical resection of the kidney or ureter will be offered WST11 VTP treatment to be provided at the time of scheduled endoscopic procedure. At the time of endoscopy, patients will be treated with VTP therapy applied to the site of the tumor.
干预措施: Endoscopy (Procedure)
结局指标
主要结局
Maximum tolerated laser fluence rate
时间窗: 2 years
The MTD will be defined as the dose whose toxicity rate does not exceed an acceptable threshold of toxicity 20%.in this study, we shall start at 100mW/cm and will carefully escalate the dose to a maximum of 200 mW/cm.
次要结局
未报告次要终点