A Phase 2 Open-Label Pilot Safety Study of JX-594 (Vaccinia GM-CSF/Thymidine Kinase-Deactivated Virus) Administered by IV Infusion Followed by Intratumoral Injection Prior to Standard Sorafenib Treatment in Patients With Unresectable Primary Hepatocellular Carcinoma
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