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
  Purpose

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 Intervention Phase
Sarcoma
Soft Tissue Sarcoma
Breast Cancer
Drug: LUM015
Phase 1

Study Type: Interventional
Study Design: Endpoint Classification: Bio-equivalence Study
Intervention Model: Single Group Assignment
Masking: 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

Resource links provided by NLM:


Further study details as provided by Duke University:

Primary Outcome Measures:
  • 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


Secondary Outcome Measures:
  • 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.


Estimated Enrollment: 15
Study Start Date: June 2012
Estimated Study Completion Date: July 2015
Estimated Primary Completion Date: December 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility

Ages Eligible for Study:   18 Years to 74 Years
Genders Eligible for Study:   Both
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01626066

Locations
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
Principal Investigator: Brian Brigman, MD Duke University
  More Information

No publications provided

Responsible Party: David Kirsch, Associate Professor of Radiation Oncology, Duke University Medical Center
ClinicalTrials.gov Identifier: NCT01626066     History of Changes
Other Study ID Numbers: Pro00035444
Study First Received: June 20, 2012
Last Updated: August 13, 2014
Health Authority: United States: Food and Drug Administration
United States: Institutional Review Board

Additional relevant MeSH terms:
Sarcoma
Breast Neoplasms
Neoplasms, Connective and Soft Tissue
Neoplasms by Histologic Type
Neoplasms
Neoplasms by Site
Breast Diseases
Skin Diseases

ClinicalTrials.gov processed this record on September 18, 2014