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Completed

NCT Number: NCT01626066

Cathepsin Activatable Fluorescent Probe

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.

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Key information

Conditions

Sarcoma Breast Cancer Breast Diseases Breast Neoplasms Neoplasms Neoplasms by Histologic Type Neoplasms by Site Neoplasms, Connective and Soft Tissue Skin Diseases Skin and Connective Tissue Diseases Soft Tissue Sarcoma

Age range

18 year–74 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Duke University Medical Center

Durham, North Carolina, 27710, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

LUM015

Drug

LUM015 assigned dose given once by IV push

Primary outcomes

  1. Dose of LUM015 in mg

    Time frame: 24 hours

    Dose of LUM015 in mg that is tolerated and labels tumors

Secondary outcomes

  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.

Sponsors and collaborators

Lead sponsor

David Kirsch

Other

Collaborators

  • American Society of Clinical Oncology

Registry information

Official study title

A Phase I Study of the Safety and Activation of a Cathepsin-Activatable Fluorescent Cancer Specific Probe LUM015

Acronym: LUM015

Important dates

Study start
2012
Primary completion
2014
Study completion
2015
First posted
Jun 22, 2012
Registry last updated
Dec 9, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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