A Phase I Study of the Safety and Activation of a Cathepsin-Activatable Fluorescent Cancer Specific Probe LUM015
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- David Kirsch
- 入组人数
- 15
- 试验地点
- 1
- 主要终点
- Dose of LUM015 in mg
研究概览
简要总结
Real-time detection of cancer cells during surgical removal of a tumor is important. Currently when tissue is removed at the time of surgery, the removed tissue goes to pathology when the margins (edges of the tissue) are examined to see if cancer cells are present. This may take a few to several days. Patients tissue with positive (cancer cells present) margins may require additional therapies including surgery. The purpose of this study is to determine a safe dose of a new imaging agent (LUM015), like a fluorescent contrast agent or dye, that will show in the tumor area during surgery and may help facilitate visualization of tumor for its removal.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Diagnostic
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 74 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •18 years of age or older
- •Diagnosis of soft tissue sarcoma and breast cancer patients scheduled for a lumpectomy or mastectomy.
- •Subjects must be scheduled for surgical resection of a tumor at least 1 cm in size.
- •Performance status of 0 or 1
- •Able to read, understand and sign an informed consent form
- •Must be able and willing to follow study procedures and instructions including a possible overnight stay before surgery
- •Otherwise healthy except for the diagnosis of cancer
- •ALT, AST, and total bilirubin within 1.5x institutional upper normal limits; and alkaline phosphatase within 2.5x institutional upper normal limits
- •Serum creatinine of 1.5 mg or less; creatinine clearance greater than 30 ml/min
- •May have previously received pre-operative external beam radiation therapy for this sarcoma
排除标准
- •Pregnant or lactating
- •Prolonged QT interval: corrected QT interval (QTc) > 480 msec
- •Insulin dependent diabetes
- •History of anaphylactic reactions to any drug or contrast agent
- •Asthma under medical management
- •Uncontrolled high blood pressure
- •Severe, active co-morbidity
- •Known substance addiction
- •Sexually active and not willing/able to use medically acceptable forms of contraception.
- •Obesity defined as BMI as body mass index greater than 35 kg/meter squared.
- •Atopy or atopic syndrome
- •Known AIDS
- •Cannot have taken an investigational drug within 30 days of coming onto this study
研究组 & 干预措施
LUM015
Receive single dose of LUM015 through a vein in the arm the day prior to surgery
干预措施: LUM015 (Drug)
结局指标
主要结局
Dose of LUM015 in mg
时间窗: 24 hours
Dose of LUM015 in mg that is tolerated and labels tumors
次要结局
- To obtain PK/PD information regarding LUM015 when administered IV in patients.(Two years)
- Mean number of fluorescence counts per second per square centimeter(At time of surgery)
- To analyze cathepsin protease expression in tumors.(2 Years)
研究者
David Kirsch
Associate Professor of Radiation Oncology
Duke University