A Phase 3 Study of Talaporfin Sodium and Interstitial Light Emitting Diodes Treating Hepatocellular Carcinoma (HCC)

• Status: Completed
• Trial end date: 2012-09-01
• Target enrollment: 0
• Participant gender: All

Summary

The purpose of the study is to assess the survival of patients treated with Litx™ versus standard of care therapies in the treatment of unresectable hepatocellular carcinoma (HCC), and to demonstrate the safety of Litx™ therapy.

Litx™ consists of a light-activated drug, talaporfin sodium (LS11, Light Sciences Oncology, Bellevue, Washington), and a light generating device, composed of light-emitting diodes (LEDs), that is energized by a power controller and percutaneously placed in the target tissue inside the body.

• Phase: Phase 3
• 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: A. Two different imaging techniques with characteristics that suggest HCC; B. Combination of one imaging technique that suggests HCC and serum AFP level >400 ng/mL; C. Histological evidence of HCC

• ECOG Performance Status 0-2

• Life expectancy of at least 16 weeks

• Patients may have received previous antineoplastic therapy; at least 3 weeks must have elapsed since the completion of any prior therapy and the patient 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/mm³ ; Platelet Count >= 75,000/µl ; Hemoglobin >= 9.4 gm/dL ; PT and PTT <= 1.5 Control ; SGOT, SGPT <= 5 × ULN ; Bilirubin <= 2.5 × ULN ; Alk Phos <= 3 × ULN ; Creatinine <= 2.5 mg/dL (SI: 221 mmol/L) ; Albumin >= 2 g/dL

Exclusion Criteria:

• Patients who are candidates for surgery with curative intent are not eligible

• Patients with 6 or more lesions are not eligible

• Patients with greater than 50% of parenchyma disease involvement are excluded

• Patients with Child-Pugh C cirrhosis are excluded

• Patients with diffuse HCC are excluded

• Patients with grade 3 ascites are excluded

• Evidence of major vessel invasion or extrahepatic disease is excluded. Lymph node involvement in the hilum region of the liver is eligible if the nodes do not exceed 2 cm.

• Known sensitivity to porphyrin-type drugs or known history of porphyria are exclusionary

• Pregnancy or breast-feeding patients are excluded. A negative pregnancy test (urine or serum) from women of childbearing age is required prior to enrollment. A fertile patient must use effective contraception during participation in the study

• Concurrent participation in another clinical trial involving experimental treatment is excluded

• Any concurrent disease or condition that in the opinion of the investigator impairs the patient's ability to complete the trial such as 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 are excluded.