Status:
COMPLETED
A Study of Recombinant Vaccinia Virus Prior to Sorafenib to Treat Unresectable Primary Hepatocellular Carcinoma
Lead Sponsor:
Jennerex Biotherapeutics
Conditions:
Carcinoma, Hepatocellular
Eligibility:
All Genders
18+ years
Phase:
PHASE2
Brief 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.
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
August 1 2009
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 1 2015
Estimated Enrollment :
25 Patients enrolled
Trial Details
Trial ID
NCT01171651
Start Date
August 1 2009
End Date
December 1 2015
Last Update
January 20 2016
Active Locations (2)
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1
Pusan National University Hospital
Busan, South Korea
2
Pusan National University Yangsan Hospital
Yangsan, South Korea