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Cathepsin Activatable Fluorescent Probe (LUM015)

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ClinicalTrials.gov Identifier: NCT01626066
Recruitment Status : Completed
First Posted : June 22, 2012
Last Update Posted : December 9, 2015
Sponsor:
Collaborator:
American Society of Clinical Oncology
Information provided by (Responsible Party):
David Kirsch, Duke University

Tracking Information
First Submitted Date  ICMJE June 20, 2012
First Posted Date  ICMJE June 22, 2012
Last Update Posted Date December 9, 2015
Study Start Date  ICMJE June 2012
Actual Primary Completion Date August 2014   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: June 20, 2012)
Dose of LUM015 in mg [ Time Frame: 24 hours ]
Dose of LUM015 in mg that is tolerated and labels tumors
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: October 21, 2013)
  • Mean number of fluorescence counts per second per square centimeter [ Time Frame: At time of surgery ]
  • To obtain PK/PD information regarding LUM015 when administered IV in patients. [ Time Frame: Two years ]
    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 ]
    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.
Original Secondary Outcome Measures  ICMJE
 (submitted: June 20, 2012)
Mean number of fluorescence counts per second per square centimeter [ Time Frame: At time of surgery ]
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Cathepsin Activatable Fluorescent Probe
Official Title  ICMJE A Phase I Study of the Safety and Activation of a Cathepsin-Activatable Fluorescent Cancer Specific Probe LUM015
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.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 1
Study Design  ICMJE Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Condition  ICMJE
  • Sarcoma
  • Soft Tissue Sarcoma
  • Breast Cancer
Intervention  ICMJE Drug: LUM015
LUM015 assigned dose given once by IV push
Study Arms  ICMJE Experimental: LUM015
Receive single dose of LUM015 through a vein in the arm the day prior to surgery
Intervention: Drug: LUM015
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: June 20, 2012)
15
Original Estimated Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE August 2015
Actual Primary Completion Date August 2014   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 74 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01626066
Other Study ID Numbers  ICMJE Pro00035444
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party David Kirsch, Duke University
Study Sponsor  ICMJE David Kirsch
Collaborators  ICMJE American Society of Clinical Oncology
Investigators  ICMJE
Principal Investigator: Brian Brigman, MD Duke University
PRS Account Duke University
Verification Date December 2015

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