NCT00068068

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

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

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 25 (planned)
• Sponsor: Light Sciences LLC · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

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.

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.

Conditions

• Liver Metastasis
• Colorectal Neoplasms
• Liver Neoplasms
• Neoplasm Metastasis

Interventions

Type	Name	Description
DRUG	Talaporfin sodium (LS11)
DEVICE	LED-based light infusion device
DEVICE	Light emitting diodes (LED)
PROCEDURE	Photodynamic therapy
PROCEDURE	Phototherapy
PROCEDURE	Chemotherapy

Timeline

• Start date: 2003-10-01
• First posted: 2003-09-08
• Last updated: 2006-09-19

Locations

6 sites across 2 countries: United States, Germany