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Trial record 1 of 3 for:    david kirsch
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Cathepsin Activatable Fluorescent Probe (LUM015)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
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

Study Description
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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.

Condition or disease Intervention/treatment Phase
Sarcoma Soft Tissue Sarcoma Breast Cancer Drug: LUM015 Phase 1

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 15 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Official Title: A Phase I Study of the Safety and Activation of a Cathepsin-Activatable Fluorescent Cancer Specific Probe LUM015
Study Start Date : June 2012
Actual Primary Completion Date : August 2014
Actual Study Completion Date : August 2015

Resource links provided by the National Library of Medicine


Arms and Interventions
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Arm Intervention/treatment
Experimental: LUM015
Receive single dose of LUM015 through a vein in the arm the day prior to surgery
 Drug: LUM015
LUM015 assigned dose given once by IV push


Outcome Measures
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Primary Outcome Measures :
  1. Dose of LUM015 in mg [ Time Frame: 24 hours ]
    Dose of LUM015 in mg that is tolerated and labels tumors


Secondary Outcome Measures :
  1. Mean number of fluorescence counts per second per square centimeter [ Time Frame: At time of surgery ]
  2. 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.

  3. 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.


Eligibility Criteria
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Ages Eligible for Study:   18 Years to 74 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01626066


Locations
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United States, North Carolina
Duke University Medical Center
Durham, North Carolina, United States, 27710
Sponsors and Collaborators
David Kirsch
American Society of Clinical Oncology
Investigators
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Principal Investigator: Brian Brigman, MD Duke University
More Information
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Responsible Party: David Kirsch, Associate Professor of Radiation Oncology, Duke University
ClinicalTrials.gov Identifier: NCT01626066    
Other Study ID Numbers: Pro00035444
First Posted: June 22, 2012    Key Record Dates
Last Update Posted: December 9, 2015
Last Verified: December 2015
Additional relevant MeSH terms:
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Sarcoma
Neoplasms, Connective and Soft Tissue
Neoplasms by Histologic Type
Neoplasms