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Sponsored by: |
Light Sciences LLC |
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Information provided by: | Light Sciences LLC |
ClinicalTrials.gov Identifier: | NCT00068068 |
The purpose of this study is to determine whether the Litx platform is safe and effective 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 |
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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 |
Study Type: | Interventional |
Study Design: | Treatment, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Safety/Efficacy Study |
Official Title: | Safety and Efficacy of Treating Refractory Cancers With the Litx™ System: Phase II Safety and Efficacy Study in Patients With Liver Metastases From Colorectal Cancer That Have Failed Chemotherapy |
Estimated Enrollment: | 25 |
Study Start Date: | October 2003 |
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 infusion devices depending on their tumor characteristics. No more than 4 light sources will be used at a single treatment. The light infusion devices may be used in a single lesion or in multiple lesions.
Following radiographic confirmation of light infusion device placement, patients will receive an intravenous dose of LS11 at 40 mg/m². One hour following completion of LS11 administration, delivery of 200 J/cm light energy will begin. The light infusion device will then be manually removed and the patients will be observed for acute complication of light infusion device 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 30+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 the tumor size, as well as tumor necrosis. The patient may then receive 5-FU and/or leucovorin + either irinotecan or oxaliplatin standard chemotherapy at day 30 visit. All patients, with or without chemotherapy at day 30, will undergo final clinical assessment and final tumor imaging evaluation using contrast CT at day 60+5 of Litx treatment.
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria
Exclusion Criteria
Patients must be excluded if any of the following apply:
United States, Colorado | |
HealthOne Alliance/Presbyterian St. Lukes Medical Center | |
Denver, Colorado, United States, 80218 | |
United States, North Carolina | |
Eastern Carolina University, School of Medicine | |
Greenville, North Carolina, United States, 27858 | |
United States, Pennsylvania | |
Allegheny General Hospital | |
Pittsburgh, Pennsylvania, United States, 15212 | |
University of Pennsylvania / Department of Radiation Oncology | |
Philadelphia, Pennsylvania, United States, 19104 | |
United States, Washington | |
Virginia Mason Medical Center | |
Seattle, Washington, United States, 98101 | |
Germany | |
University Hospital Frankfurt, Johann Wolfgang Goethe-University | |
Frankfurt am Main, Germany, D-60596 |
Study ID Numbers: | LSC-OL002 |
Study First Received: | September 4, 2003 |
Last Updated: | September 18, 2006 |
ClinicalTrials.gov Identifier: | NCT00068068 |
Health Authority: | United States: Food and Drug Administration |
Photodynamic therapy Liver metastases Colorectal cancer Litx™ Light Infusion Technology™ Talaporfin sodium |
LS11 Liver mets Metastatic colorectal cancer Light emittting diodes (LED) Tumor ablation Combination therapy |
Liver Diseases Digestive System Neoplasms Talaporfin Gastrointestinal Diseases Colonic Diseases Liver neoplasms Intestinal Diseases |
Rectal Diseases Intestinal Neoplasms Liver Neoplasms Digestive System Diseases Neoplasm Metastasis Gastrointestinal Neoplasms Colorectal Neoplasms |
Photosensitizing Agents Neoplastic Processes Neoplasms Pathologic Processes Neoplasms by Site Radiation-Sensitizing Agents |
Antineoplastic Agents Therapeutic Uses Physiological Effects of Drugs Dermatologic Agents Pharmacologic Actions |