Photodynamic Therapy With Talaporfin Sodium (LS11) in Treating Patients With Refractory Colorectal Liver Metastases

This study has been completed.
Sponsor:
Information provided by:
Light Sciences LLC
ClinicalTrials.gov Identifier:
NCT00068068
First received: September 4, 2003
Last updated: September 18, 2006
Last verified: September 2006
  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 2

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
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

Resource links provided by NLM:


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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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
University of Pennsylvania / Department of Radiation Oncology
Philadelphia, Pennsylvania, United States, 19104
Allegheny General Hospital
Pittsburgh, Pennsylvania, United States, 15212
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

Additional Information:
Publications:
ClinicalTrials.gov Identifier: NCT00068068     History of Changes
Obsolete Identifiers: NCT00078871
Other Study ID Numbers: LSC-OL002
Study First Received: September 4, 2003
Last Updated: September 18, 2006
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

Additional relevant MeSH terms:
Neoplasms
Colorectal Neoplasms
Liver Neoplasms
Neoplasm Metastasis
Neoplasms, Second Primary
Intestinal Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Digestive System Diseases
Gastrointestinal Diseases
Colonic Diseases
Intestinal Diseases
Rectal Diseases
Liver Diseases
Neoplastic Processes
Pathologic Processes
Talaporfin
Antineoplastic Agents
Therapeutic Uses
Pharmacologic Actions
Photosensitizing Agents
Dermatologic Agents
Radiation-Sensitizing Agents

ClinicalTrials.gov processed this record on August 21, 2014