Cathepsin Activatable Fluorescent Probe (LUM015)

David Kirsch

Status and phase: Completed; Phase 1

Conditions: Breast Cancer; Sarcoma; Soft Tissue Sarcoma

Treatments: Drug: LUM015

Study type: Interventional

Funder types: Other

Identifiers

NCT01626066

Pro00035444

Details and patient eligibility

About

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.

Enrollment: 15 patients

Sex: All

Ages: 18 to 74 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• 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

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

Trial design

Primary purpose: Diagnostic

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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15 participants in 1 patient group

LUM015

Experimental group

Description:

Receive single dose of LUM015 through a vein in the arm the day prior to surgery

Treatment:

Drug: LUM015