A Study of Recombinant Vaccinia Virus Prior to Sorafenib to Treat Unresectable Primary Hepatocellular Carcinoma
Phase 2
Completed
- Conditions
- Carcinoma, Hepatocellular
- Interventions
- Drug: JX-594 followed by sorafenib
- Registration Number
- NCT01171651
- Lead Sponsor
- Jennerex Biotherapeutics
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 25
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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description JX-594 followed by sorafenib JX-594 followed by sorafenib 1e9 pfu (plaque-forming units) total JX-594 dose on each of up to four (4) JX-594 treatment days. Sorafenib is initiated after 3 JX-594 treatments and briefly interrupted if an optional 4th JX-594 treatment is given.
- Primary Outcome Measures
Name Time Method Determine safety and tolerability of intravenous infusion of JX-594 followed by intratumoral injections with JX-594 prior to standard sorafenib therapy Safety evaluations through 28 days after last dose of JX-594 Adverse events will be collected and assessed to assess safety and tolerability through 28 days after last dose of JX-594 (or until all events considered probably or possibly related to JX-594 have resolved, stabilized, or returned to baseline status).
- Secondary Outcome Measures
Name Time Method Determine Disease Control Rate (DCR) at 12 weeks Disease control and response assessment at 12 weeks from first JX-594 dose DCR: confirmed complete response, partial response or stable disease based on modified RECIST and/or Choi response criteria
Determine overall survival time Ongoing (average of 1 year) Determine radiographic response rate Periodically throughout study participation (average of up to 1 year) Response rate evaluation based on modified RECIST and/or Choi response criteria
Trial Locations
- Locations (2)
Pusan National University Hospital
🇰🇷Busan, Korea, Republic of
Pusan National University Yangsan Hospital
🇰🇷Yangsan, Korea, Republic of
Pusan National University Hospital🇰🇷Busan, Korea, Republic of