Tumor Ablation With Talaporfin Sodium and Interstitial Light Emitting Diodes Treating Hepatocellular Carcinoma (HCC)

• Status: Completed
• Trial end date: 2006-10-01
• Target enrollment: 0
• Participant gender: All

Summary

The purpose of this study is to determine whether the Litx™ treatment is safe and effective in treating inoperable hepatocellular carcinoma (HCC).

Litx™ is an integrated treatment system comprising an intravenously administered photosensitizing agent, Talaporfin Sodium (LS11), that is activated by non-coherent light generated inside the tumor by an implanted light emitting diode (LED) array light source.

• Phase: Phase 1/Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Light Sciences Oncology
• Treatments: Talaporfin

Criteria

Inclusion Criteria:

• A diagnosis of primary Hepatocellular Carcinoma (HCC), established by any one of the following criteria in a clinical setting suggestive of HCC: (i) Two different imaging techniques that suggests HCC; (ii) Combination of one imaging technique that suggests HCC and serum alpha-fetoprotein (AFP) level >400 ng/mL; (iii) Histological evidence of HCC;

• Subjects with at least 1 but no more than 3 lesions in the liver may be considered for enrollment in the study;

• Eastern Cooperative Oncology Group (ECOG) performance status 0-2;

• Life expectancy of at least 16 weeks;

• Prior treatment failure with locally ablative techniques is allowed. Subjects who were not candidates for surgery, systemic chemotherapy, chemoembolization (TACE), intratumoral ethanol injection (PEI), radiofrequency ablation (RFA), cryoablation or other locally ablative technology may be eligible, but at least 4 weeks must have elapsed since the completion of any prior therapy and the subject must have recovered from acute side effects;

• Understanding and ability to sign written informed consent;

• 18 years of age or more;

• Adequate hematologic, liver and renal functions as evidenced by the following: *WBC > 2,400/mm; *Platelet Count > 75,000/µl; *Hemoglobin > 9.4 gm/dL; *PT and PTT < 1.5 Control; *AST, ALT < 5 x ULN; *Bilirubin < 1.5 X ULN; *Alk Phos < 3X ULN; *Creatinine < 2.5 mg/dL (SI: 221 mmol/L)

Exclusion Criteria:

• Subjects who are candidates for surgery with curative intent;

• Subjects with lesions larger than 8 cm in diameter and more than 40% of parenchymal disease involvement;

• Known sensitivity to porphyrin type drugs;

• Known history of porphyria;

• Known presence of extrahepatic metastases;

• Anticipated need for systemic chemotherapy during the first 8 weeks of the study;

• Child-Pugh C cirrhosis;

• Diffuse HCC;

• Concurrent participation in another clinical trial involving experimental treatment;

• Any concurrent disease or condition that in the opinion of the investigator impairs the subject's ability to complete the trial. Psychological, familial, sociological, geographical or medical conditions which in the Principal Investigator's opinion could compromise compliance with the objectives and procedures of this protocol or obscure interpretation of the trial's data.