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Cathepsin Activatable Fluorescent Probe (LUM015)

Primary Purpose

Sarcoma, Soft Tissue Sarcoma, Breast Cancer

Status

Completed

Phase

Phase 1

Locations

United States

Study Type

Interventional

Intervention

LUM015

About this trial

This is an interventional diagnostic trial for Sarcoma

Eligibility Criteria

18 Years - 74 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

Duke University Medical Center

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

LUM015

Arm Description

Receive single dose of LUM015 through a vein in the arm the day prior to surgery

Outcomes

Primary Outcome Measures

Dose of LUM015 in mg

Dose of LUM015 in mg that is tolerated and labels tumors

Secondary Outcome Measures

Mean number of fluorescence counts per second per square centimeter

To obtain PK/PD information regarding LUM015 when administered IV in patients.

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.

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.

Full Information

NCT ID

NCT01626066

First Posted

June 20, 2012

Last Updated

December 8, 2015

Sponsor

David Kirsch

Collaborators

American Society of Clinical Oncology

1. Study Identification

Unique Protocol Identification Number

NCT01626066

Brief Title

Cathepsin Activatable Fluorescent Probe

Acronym

LUM015

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

December 2015

Overall Recruitment Status

Completed

Study Start Date

June 2012 (undefined)

Primary Completion Date

August 2014 (Actual)

Study Completion Date

August 2015 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor-Investigator

Name of the Sponsor

David Kirsch

Collaborators

American Society of Clinical Oncology

4. Oversight

Data Monitoring Committee

Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Sarcoma, Soft Tissue Sarcoma, Breast Cancer

7. Study Design

Primary Purpose

Diagnostic

Study Phase

Phase 1

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

N/A

Enrollment

15 (Actual)

8. Arms, Groups, and Interventions

Arm Title

LUM015

Arm Type

Experimental

Arm Description

Receive single dose of LUM015 through a vein in the arm the day prior to surgery

Intervention Type

Drug

Intervention Name(s)

LUM015

Intervention Description

LUM015 assigned dose given once by IV push

Primary Outcome Measure Information:

Title

Dose of LUM015 in mg

Description

Dose of LUM015 in mg that is tolerated and labels tumors

Time Frame

24 hours

Secondary Outcome Measure Information:

Title

Mean number of fluorescence counts per second per square centimeter

Time Frame

At time of surgery

Title

To obtain PK/PD information regarding LUM015 when administered IV in patients.

Description

Time Frame

Two years

Title

To analyze cathepsin protease expression in tumors.

Description

Time Frame

2 Years

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

74 Years

Accepts Healthy Volunteers

Eligibility 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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Brian Brigman, MD

Organizational Affiliation

Duke University

Official's Role

Principal Investigator

Facility Information:

Facility Name

Duke University Medical Center

City

Durham

State/Province

North Carolina

ZIP/Postal Code

27710

Country

United States

12. IPD Sharing Statement

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Cathepsin Activatable Fluorescent Probe

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