Study of the Litx™ System Combined With Chemotherapy in Patients With Colorectal Liver Metastases

April 10, 2007 updated by: Light Sciences LLC

Safety and Effectiveness of Treating Cancers With the Litx™ System and Chemotherapy. Section A: Phase II Safety and Effectiveness Study in Patients With Liver Metastases From Colorectal Cancer

The purpose of this study is to determine whether the Litx™ system is safe and effective in combination with chemotherapy in the treatment of liver metastasis arising from colorectal cancer. Litx™ is a next-generation photodynamic therapy platform in which the drug, talaporfin sodium (LS11), is activated by light from the light-emitting diode (LED)-based light infusion device, inserted directly into the tumor through the skin prior to treatment.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Patients that provide Informed Consent and satisfy the Eligibility Criteria will undergo CT or Ultrasound guided percutaneous placement of a single, two, three, or four Light Sources depending on their tumor characteristics. No more than 4 Light Sources will be used at a single treatment. The Light Sources may be used in a single lesion or in multiple lesions.

Following radiographic confirmation of Light Source placement, patients will receive an intravenous dose of LS11 at 40 mg/m². Fifteen minutes to 1 hour following completion of LS11 administration, delivery of 200 J/cm at 20 mW/cm light energy will begin. The Light Source will then be manually removed and the patients will be observed for acute complication of Light Source removal. Precautions for protection from external light exposure should be instituted beginning with the LS11 administration and be maintained as defined throughout the study period. On day 3 following Litx™ treatment the patient will receive a standard chemotherapy with Irinotecan or Oxaliplatin with or without 5FU and /or leucovorin for metastatic colorectal cancer. On day 30+5 and day 60+5 the patient will undergo clinical assessment and the tumor mass will be imaged using contrast enhanced spiral CT for determination of volume and radius of PDT necrosis.

Study Type

Interventional

Enrollment

25

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Washington
      • Seattle, Washington, United States, 98101
        • Virginia Mason Medical Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

16 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Patients with metastatic liver lesions from colorectal disease
  • Biopsy proven evidence of colorectal cancer
  • Patients with 4 or fewer lesions greater than 1 cm and with no single lesion greater than 7 cm in maximum diameter
  • Age greater than or equal to 18 years
  • Patients must be able to sign informed consent
  • Life expectancy greater than or equal to 3 months
  • ECOG performance status 0-2
  • Patients with extrahepatic disease in addition to their hepatic metastases may be eligible
  • Must have recovered from the toxicity from any prior antineoplastic therapy

Exclusion Criteria:

  • Patients who are candidates for complete surgical resection
  • Pregnancy or breast-feeding. A negative pregnancy test (urine or serum) is required prior to enrollment
  • Known uncontrollable serious reactions such as anaphylaxis, to the contrast agents used in this study
  • PT or PTT greater than 1.5X control
  • Platelet count less than 100,000
  • WBC less than 2500/mm
  • Neutrophils less than 2000/mm
  • Hemoglobin less than 9 g/dL
  • Liver enzymes (AST, ALT, GGT, alkaline phosphatase) greater than 3 X ULN
  • Total bilirubin greater than 1.5 X ULN
  • Serum creatinine greater than 2.5 X ULN
  • Patients who have been treated with either AVASTIN™ (Bevacizumab) or ERBITUX™ (Cetuximab) within the previous 4 weeks (28 days)

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Non-Randomized
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Light Sciences LLC

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

May 1, 2004

Study Registration Dates

First Submitted

June 2, 2004

First Submitted That Met QC Criteria

June 2, 2004

First Posted (Estimate)

June 3, 2004

Study Record Updates

Last Update Posted (Estimate)

April 11, 2007

Last Update Submitted That Met QC Criteria

April 10, 2007

Last Verified

April 1, 2007

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • LSC-OL003

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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