A Phase 2b Study of Modified Vaccinia Virus to Treat Patients Advanced Liver Cancer Who Failed Sorafenib
- Conditions
- HCCHepatocellular CarcinomaLiver Cancer
- Interventions
- Other: Best Supportive CareBiological: JX-594 recombinant vaccina GM-CSF
- Registration Number
- NCT01387555
- Lead Sponsor
- Jennerex Biotherapeutics
- Brief Summary
This study is to determine whether JX-594 (Pexa-Vec) plus best supportive care is more effective in improving survival than best supportive care in patients with advanced Hepatocellular Carcinoma (HCC) who have failed sorafenib.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 129
- Diagnosis of primary HCC by tissue biopsy (histological/cytological diagnosis), or clinical diagnosis
- Previously treated with sorafenib for ≥ 14 days and has discontinued sorafenib treatment at least 14 days prior to randomization due to either intolerance or radiographic progression NOTE: Sorafenib is NOT required to be the most recent treatment received for HCC
- ECOG performance status 0, 1 or 2
- Child-Pugh Class A; or Child-Pugh Class B7 without clinically significant ascites
- Hematocrit ≥30% or Hemoglobin ≥10 g/dL
- Tumor status: Measurable viable tumor in the liver and injectable under imaging-guidance; At least one tumor in the liver that has not received prior local-regional treatment OR that has exhibited >25% growth in viable tumor size since prior local-regional treatment.
KEY
- Received sorafenib within 14 days prior to randomization
- Received systemic anti-cancer therapy other than sorafenib within 28 days of randomization
- Prior treatment with JX-594
- Platelet count < 50,000 PLT/ mm3
- Total white blood cell count < 2,000 cells/mm3
- Prior or planned organ transplant
- Known significant immunodeficiency due to underlying illness (e.g. HIV/AIDS) and/or medication
- Severe or unstable cardiac disease
- Viable CNS malignancy associated with clinical symptoms
- Pregnant or nursing an infant
- History of inflammatory skin condition (e.g., eczema requiring previous treatment, atopic dermatitis)
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Arm B Best Supportive Care Patients on the control arm (Arm B) will have best supportive care over 18 weeks. Arm A JX-594 recombinant vaccina GM-CSF Patients on Arm A will receive 1 e9 pfu (plaque forming units) total dose of JX-594 (Vaccinia GM-CSF / TK-deactivated Virus) on each of six (6) treatments over 18 weeks.
- Primary Outcome Measures
Name Time Method Survival CT scan every six weeks until progression or death, assessed up to 21 months Determine overall survival for patients receiving JX-594 plus best supportive care (Arm A) compared with those patients receiving best supportive care (Arm B) in patients with advanced hepatocellular carcinoma (HCC) who have failed sorafenib treatment.
- Secondary Outcome Measures
Name Time Method Time to Tumor Progression CT scan every six weeks until progression or death, assessed up to 21 months Determine time-to-tumor-progression (TTP) for Arm A compared with Arm B based on mRECIST for HCC.
Quality of Life assessed up to 21 months (average) Determine the Quality of Life (QoL) of patients treated in Arm A compared with Arm B.
Tumor Response CT scan every 6 weeks until progression or death, assessed up to 21 months (average) Determine tumor response based on mRECIST for HCC of Arm A versus Arm B
Safety profile of JX594 assessed up to 21 months (average) Safety will be assessed by the number of adverse events (AEs) and serious adverse events (SAEs)
Time-to-symptomatic-progression assessed up to 21 months (average) Determine time to progression of Arm A compared to Arm B.
Trial Locations
- Locations (38)
Billings Clinic
🇺🇸Billings, Montana, United States
National Taiwan University Hospital
🇨🇳TPE, Taiwan
University of British Columbia
🇨🇦Vancouver, British Columbia, Canada
California Pacific Medical Center
🇺🇸San Francisco, California, United States
Moores University of California San Diego Cancer Center
🇺🇸La Jolla, California, United States
Chao Family Comprehensive Cancer Center
🇺🇸Orange, California, United States
Stanford Hospital and Clinics
🇺🇸Stanford, California, United States
Saint Joseph's Hospital
🇺🇸Paterson, New Jersey, United States
University of Chicago Medical Center
🇺🇸Chicago, Illinois, United States
Gabrail Cancer Center
🇺🇸Canton, Ohio, United States
The Methodist Hospital Department of Surgery
🇺🇸Houston, Texas, United States
University Hospitals Case Medical Center
🇺🇸Cleveland, Ohio, United States
Juravinski Cancer Centre
🇨🇦Hamilton, Ontario, Canada
University of Alberta
🇨🇦Edmonton, Alberta, Canada
Ottawa Hopsital Research Institute
🇨🇦Ottawa, Ontario, Canada
Hôpitaux Universitaires de Strasbourg - Hôpital Civil
🇫🇷Strasbourg Cedex, Alsace, France
CHU d'Estaing
🇫🇷Clermont-Ferrand, Auvergne, France
Hôpital Saint Antoine, CPP Ile de France V
🇫🇷Paris, Ile-de-France, France
Centre Hospitalier Universitaire Hôpital Saint André
🇫🇷Bordeaux, Aquitaine, France
Hôpital Purpan
🇫🇷Toulouse, Midi-Pyrenees, France
Hôpital de la Croix Rousse
🇫🇷Lyon Cedex, Rhone-Alpes, France
Johannes Gutenberg-Universität Mainz
🇩🇪Mainz, Rheinland-Pfalz, Germany
Klinikum Rechts der Isar der Technischen Universität München
🇩🇪München, Bayern, Germany
Universitätsklinikum Hamburg-Eppendorf
🇩🇪Hamburg, Germany
Korea University Ansan Hospital
🇰🇷Ansan-si, Gyeonggi-Do, Korea, Republic of
Pusan National University Hospital
🇰🇷Pusan, Korea, Republic of
Kyungpook National University Hospital
🇰🇷Daegu, Korea, Republic of
Korea University Guro Hospital
🇰🇷Seoul, Korea, Republic of
Asan Medical Center
🇰🇷Seoul, Korea, Republic of
Seoul National University Hospital
🇰🇷Seoul, Korea, Republic of
Severance Hospital,Yonsei University Health System
🇰🇷Seoul, Korea, Republic of
National Cheng-Kung University Hospital
🇨🇳TPE, Taiwan
Taipei Veterans General Hospital
🇨🇳TPE, Taiwan
Medizinische Hochschule Hannover
🇩🇪Hannover, Niedersachsen, Germany
Pusan National University Yangsan Hospital
🇰🇷Yangsan, Korea, Republic of
Samsung Medical Center
🇰🇷Seoul, Korea, Republic of
Montefiore Medical Center
🇺🇸Bronx, New York, United States
Queen Mary Hospital
ðŸ‡ðŸ‡°Hong Kong, Hong Kong