Cathepsin Activatable Fluorescent Probe

NCT01626066 | Completed Phase 1 DMC

• 1 other identifier: Pro00035444
• Study Type: interventional
• Target: 15
• Locations: 1 country
• Sites: 1

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.

Conditions

Sarcoma; Soft Tissue Sarcoma; Breast Cancer

Outcome Measures

Primary Outcomes (1)

• Dose of LUM015 in mg

  Dose of LUM015 in mg that is tolerated and labels tumors

  24 hours

Secondary Outcomes (3)

• Mean number of fluorescence counts per second per square centimeter

  At time of surgery

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

  Two years

• To analyze cathepsin protease expression in tumors.

  2 Years

Study Arms (1)

LUM015

EXPERIMENTAL

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

Drug: LUM015

Interventions

LUM015 DRUG

LUM015 assigned dose given once by IV push

LUM015

Eligibility Criteria

• Age: 18 Years - 74 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• David Kirsch: lead
• American Society of Clinical Oncology: collaborator

Study Sites (1)

Duke University Medical Center

Durham, North Carolina, 27710, United States

Location

MeSH Terms

Conditions

Sarcoma; Breast Neoplasms

Condition Hierarchy (Ancestors)

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

Study Officials

• Brian Brigman, MD

  Duke University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Associate Professor of Radiation Oncology

Study Record Dates

• First Submitted: June 20, 2012
• First Posted: June 22, 2012
• Study Start: June 1, 2012
• Primary Completion: August 1, 2014
• Study Completion: August 1, 2015
• Last Updated: December 9, 2015

Record last verified: 2015-12

Locations

US (1)