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

• Status: Completed
• Trial end date: 1969-12-31
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Light Sciences LLC
• Treatments: Talaporfin

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.