Study of the Litx™ System Combined With Chemotherapy in Patients With Colorectal Liver Metastases
|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 2|
|Study Design:||Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
|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|
|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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00083785
|United States, Washington|
|Virginia Mason Medical Center|
|Seattle, Washington, United States, 98101|