A Study of Recombinant Vaccinia Virus Prior to Sorafenib to Treat Unresectable Primary Hepatocellular Carcinoma

• Status: Completed
• Trial end date: 2015-12-01
• Target enrollment: 0
• Participant gender: All

Summary

The purpose of this pilot safety study is to evaluate the safety and tolerability of JX-594 (Pexa-Vec) administered intravenously and intratumorally prior to standard sorafenib therapy.

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

Details

• Lead Sponsor: Jennerex Biotherapeutics
• Treatments: Niacinamide; Sorafenib

Criteria

Inclusion Criteria:

• Histological confirmation or clinical/laboratory diagnosis of primary hepatocellular carcinoma (HCC)

• Cancer is not surgically resectable for cure

• Child Pugh A or B

• Performance Score: KPS score of ≥ 70

• Platelet count ≥ 50,000 plts/mm3

• Total bilirubin ≤ 2.5 x ULN

• AST, ALT < 5.0 x ULN

• Acceptable coagulation status: INR ≤ 1.5 x ULN

• Acceptable kidney function: Serum creatinine < 2.0 mg/dL

• Sorafenib naive or refractory to sorafenib therapy Tumor Status: At least one intrahepatic tumor, and at least ≥50% of the total intrahepatic viable tumor mass, measurable by CT and injectable under imaging-guidance (note: injected and/or viable tumors must be previously untreated or ≥20% increase in size since preceding local-regional treatment).

Exclusion Criteria:

• Known contraindications to sorafenib

• Pregnant or nursing an infant

• Significant immunodeficiency due to underlying illness (e.g. hematological malignancies, congenital immunodeficiencies and/or HIV infection/AIDS) and/or medication (e.g. high-dose systemic corticosteroids)

• History of exfoliative skin condition (e.g. severe eczema, ectopic dermatitis, or similar skin disorder) that at some stage has required systemic therapy

• Clinically significant and/or rapidly accumulating ascites, peri-cardial and/or pleural effusions

• Severe or unstable cardiac disease

• Current, known CNS malignancy

• Use of anti-platelet or anti-coagulation medication

• Use of the following anti-viral agents: ribavirin, adefovir, cidofovir (within 7 days prior to the first treatment), and PEG-IFN (within 14 days prior to the first treatment).

• Patients with household contacts who meet any of these criteria unless alternate living arrangements can be made during the patient's active dosing period and for 7 days following the last dose of study medication:

• Pregnant or nursing an infant

• Children < 12 months old

• History of exfoliative skin condition that at some stage has required systemic therapy

• Significant immunodeficiency due to underlying illness (e.g. HIV/AIDS) and/or medication