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Study of the Litx™ System Combined with Chemotherapy in Patients With Colorectal Liver Metastases
This study is currently recruiting patients.
Sponsored by: | Light Sciences Corporation |
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Information provided by: | Light Sciences Corporation |
Purpose
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 | Treatment or Intervention | Phase |
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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; Cancer Alternative Therapy; Colorectal Cancer; Liver Cancer
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
Expected Total Enrollment: 25
Study start: 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.
Eligibility
Ages Eligible for Study: 18 Years and above, Genders Eligible for Study: Both
Criteria
Inclusion Criteria:
Exclusion Criteria:
Location and Contact Information
More Information
Publications
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