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Sponsored by: |
Light Sciences LLC |
Information provided by: | Light Sciences LLC |
ClinicalTrials.gov Identifier: | NCT00083785 |
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.
Condition | Intervention | Phase |
Liver Metastasis Colorectal Neoplasms Liver Neoplasms Neoplasm Metastasis |
Drug: Talaporfin sodium (LS11) Device: LED-based light infusion device Device: Light emitting diodes (LED) Procedure: Photodynamic therapy Procedure: Phototherapy Procedure: Chemotherapy |
Phase II |
MedlinePlus related topics: | Cancer Colorectal Cancer Liver Cancer |
ChemIDplus related topics: | Monoaspartyl chlorin e6 Talaporfin sodium |
Study Type: | Interventional |
Study Design: | Treatment, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Safety/Efficacy Study |
Official Title: | 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 |
Estimated Enrollment: | 25 |
Study Start Date: | May 2004 |
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.
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Sponsor website 
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Study ID Numbers: | LSC-OL003 |
First Received: | June 2, 2004 |
Last Updated: | April 10, 2007 |
ClinicalTrials.gov Identifier: | NCT00083785 |
Health Authority: | United States: Food and Drug Administration |
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