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Photodynamic Therapy With Talaporfin Sodium (LS11) in Treating Patients With Refractory Colorectal Liver Metastases
This study has been completed.
Sponsored by: Light Sciences LLC
Information provided by: Light Sciences LLC
ClinicalTrials.gov Identifier: NCT00068068
  Purpose

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
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
Drug Information available for: Monoaspartyl chlorin e6 Talaporfin sodium
U.S. FDA Resources
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

Further study details as provided by Light Sciences LLC:

Estimated Enrollment: 25
Study Start Date: October 2003
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 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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria

  • Patients with metastatic liver lesions from colorectal disease who have failed or progressed on a chemotherapy regimen for metastatic 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 are eligible and will receive systemic therapy for their extrahepatic disease following Litx therapy.
  • Off chemotherapy for 4 weeks. Must have recovered from the chemotherapy effects.

Exclusion Criteria

Patients must be excluded if any of the following apply:

  • 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 greater than 3 X ULN.
  • Total bilirubin greater than 1.5 X ULN.
  • Serum creatinine greater than 2.5 X ULN.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00068068

Locations
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
Sponsors and Collaborators
Light Sciences LLC
  More Information

Sponsor website  This link exits the ClinicalTrials.gov site

Publications:
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

Keywords provided by Light Sciences LLC:
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

Study placed in the following topic categories:
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

Additional relevant MeSH terms:
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

ClinicalTrials.gov processed this record on January 16, 2009