Cathepsin Activatable Fluorescent Probe (LUM015)

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborator:
American Society of Clinical Oncology
Information provided by (Responsible Party):
David Kirsch, Duke University Medical Center
ClinicalTrials.gov Identifier:
NCT01626066
First received: June 20, 2012
Last updated: August 13, 2014
Last verified: August 2014

June 20, 2012
August 13, 2014
June 2012
December 2014   (final data collection date for primary outcome measure)
Dose of LUM015 in mg [ Time Frame: 24 hours ] [ Designated as safety issue: Yes ]
Dose of LUM015 in mg that is tolerated and labels tumors
Same as current
Complete list of historical versions of study NCT01626066 on ClinicalTrials.gov Archive Site
  • Mean number of fluorescence counts per second per square centimeter [ Time Frame: At time of surgery ] [ Designated as safety issue: No ]
  • To obtain PK/PD information regarding LUM015 when administered IV in patients. [ Time Frame: Two years ] [ Designated as safety issue: No ]
    The pharmacokinetic parameters to be measured will include: area under the curve (AUCt), maximum concentration (Cmax), time to maximum concentration (tmax) and first-order terminal (elimination) rate constant. Secondary (derived) parameters will include: terminal half-life (t1/2), clearance (CL), mean residence time (MRT), and apparent volume of distribution during the terminal phase (Vz). The distribution of these parameters will be described for each dose cohort separately; breast and sarcoma patients will be combined.
  • To analyze cathepsin protease expression in tumors. [ Time Frame: 2 Years ] [ Designated as safety issue: No ]
    Cathepsin expression in tumors, measured in arbitrary units by Real-Time PCR compared to adjacent normal tissue when available, will be assessed in sarcomas and breast tumors. For each tissue specimen the expression of cathepsin will be compared to the imaging signal. Scatterplots of cathepsin level against imaging signal will be made according to tissue type within each dose cohort.
Mean number of fluorescence counts per second per square centimeter [ Time Frame: At time of surgery ] [ Designated as safety issue: No ]
Not Provided
Not Provided
 
Cathepsin Activatable Fluorescent Probe
A Phase I Study of the Safety and Activation of a Cathepsin-Activatable Fluorescent Cancer Specific Probe LUM015

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.

Not Provided
Interventional
Phase 1
Endpoint Classification: Bio-equivalence Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Diagnostic
  • Sarcoma
  • Soft Tissue Sarcoma
  • Breast Cancer
Drug: LUM015
LUM015 assigned dose given once by IV push
Experimental: LUM015
Receive single dose of LUM015 through a vein in the arm the day prior to surgery
Intervention: Drug: LUM015
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Active, not recruiting
15
July 2015
December 2014   (final data collection date for primary outcome measure)

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
Both
18 Years to 74 Years
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT01626066
Pro00035444
Yes
David Kirsch, Duke University Medical Center
David Kirsch
American Society of Clinical Oncology
Principal Investigator: Brian Brigman, MD Duke University
Duke University
August 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP