A Phase I Study of the Safety and Activation of a Cathepsin-Activatable Fluorescent Cancer Specific Probe LUM015
Inclusion Criteria:
- 18 years of age or older
- Diagnosis of soft tissue sarcoma (breast cancer patients scheduled for a lumpectomy
or mastectomy will be included in the expanded cohort).
- 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 an
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
Exclusion Criteria:
- 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