Clinical trial NCT01626066: Cathepsin Activatable Fluorescent Probe
Official title: A Phase I Study of the Safety and Activation of a Cathepsin-Activatable Fluorescent Cancer Specific Probe LUM015
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Sarcoma
Soft Tissue Sarcoma
Breast Cancer
Lead sponsor: Duke University
Sponsor class: OTHER
Collaborators: name: American Society of Clinical Oncology
First posted: 2012-06-22
Enrollment: 15
Sex: ALL
Minimum age (years): 18
Maximum age (years): 74
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

Brief summary: 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.


Eligibility criteria: 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

Primary outcomes:
measure: Dose of LUM015 in mg
timeFrame: 24 hours
Secondary outcomes:
measure: Mean number of fluorescence counts per second per square centimeter
timeFrame: At time of surgery
measure: To obtain PK/PD information regarding LUM015 when administered IV in patients.
timeFrame: Two years
measure: To analyze cathepsin protease expression in tumors.
timeFrame: 2 Years
Other outcomes:
Locations:
city: Durham
country: United States
facility: Duke University Medical Center
state: North Carolina
Study officials:
affiliation: Duke University
name: Brian Brigman, MD
role: PRINCIPAL_INVESTIGATOR
References: