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

Completed · Phase 2

Conditions studied: Liver Metastasis, Colorectal Neoplasms, Liver Neoplasms, Neoplasm Metastasis

In brief

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.

Key facts

Study ID

NCT00068068

Run by

Light Sciences LLC

People needed

25

Starts

2003-10-01

Last updated by the study team

2006-09-19

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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.

Where it is running

• HealthOne Alliance/Presbyterian St. Lukes Medical Center — Denver, Colorado, United States
• Eastern Carolina University, School of Medicine — Greenville, North Carolina, United States
• University of Pennsylvania / Department of Radiation Oncology — Philadelphia, Pennsylvania, United States
• Allegheny General Hospital — Pittsburgh, Pennsylvania, United States
• Virginia Mason Medical Center — Seattle, Washington, United States
• University Hospital Frankfurt, Johann Wolfgang Goethe-University — Frankfurt am Main, Germany

Full record on ClinicalTrials.gov

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