A Phase 2b Study of Recombinant Vaccinia Virus to Treat Advanced Liver Cancer
- Conditions
- Advanced hepatocellular carcinomaMedDRA version: 16.0Level: LLTClassification code 10019828Term: Hepatocellular carcinoma non-resectableSystem Organ Class: 100000004864Therapeutic area: Diseases [C] - Cancer [C04]
- Registration Number
- EUCTR2011-000051-16-DE
- Lead Sponsor
- Jennerex, Inc
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- 120
•Advanced HCC: patients are not eligible for, or had disease progression after, local-regional therapy (e.g. surgery, TACE, RFA, ethanol injection)
•Diagnosis of primary HCC by tissue biopsy, or clinical diagnosis based on EASL-EORTC guidelines
•Previously treated with sorafenib and has discontinued sorafenib treatment at least 14 days prior to randomization due to either intolerance or radiographic progression
•Any side-effects from previous sorafenib therapy have resolved to Grade 1 or better, or are well-controlled with medication in the opinion of the Investigator
•ECOG performance status 0, 1 or 2
•Child-Pugh Class A; or Child-Pugh Class B7 without clinically significant ascites
•Serum creatinine =2.0 mg/dL or creatinine clearance =60 mL/min according to Cockroft-Gault formula.
•Hematocrit =30% or Hemoglobin =10 g/dL (correction with transfusion or erythropoietin based therapy allowed to meet eligibility criteria)
•No ongoing (other than HCC) or prior malignancy except for the following: dequately treated basal or squamous cell skin cancer, in situ cervical cancer, adequately treated Stage I or Stage II cancer from which the patient is currently in complete remission, or any other cancer from which the patient has been disease-free for 3 years.
•For patients who are sexually active: patient must be able and willing to abstain for a minimum of 3 weeks after each treatment and subsequently use barrier contraception method for at least 6 weeks after each treatment of JX-594
•Tumor status (as determined by radiology evaluation):
- Measurable viable tumor in the liver (=1 cm longest diameter [LD] and enhancing on arterial phase of triphasic CT scan or MRI), and injectable under imaging-guidance (CT and/or ultrasound)
- At least one intrahepatic tumor that has not received prior local-regional treatment, or that has exhibited >25% increase in viable tumor size since prior local-regional treatment
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 60
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 60
•Major surgery within 28 days of randomization or subcutaneous venous access device placement within 7 days prior to randomization
•Locoregional therapy within 28 days prior to randomization
•Received sorafenib within 14 days prior to randomization
•Received systemic anti-cancer therapy other than sorafenib within 28 days of randomization (6 weeks in case of mitomycin C or nitrosoureas)
•Prior treatment with JX-594
•Prior or planned organ transplant
•Platelet count < 50,000 PLT/ mm3
•Total white blood cell (WBC) count < 2,000 cells/mm3
•Prior or planned organ transplant (e.g. liver transplant)
•Known significant immunodeficiency due to underlying illness (e.g. HIV/AIDS) and/or medication
•History of inflammatory skin condition
•Severe or unstable cardiac disease
•Viable CNS malignancy associated with clinical symptoms
•Anticoagulant or anti-platelet medication that cannot be interrupted prior to IT injection
•Pregnant or breastfeeding
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Main Objective: Determine overall survival (OS) for patients receiving JX-594 plus best supportive care (BSC) (Arm A) compared with those receiving BSC (Arm B) in patients with advanced hepatocellular carcinoma (HCC) who have failed sorafenib treatment.;Secondary Objective: - Determine time-to-tumor-progression (TTP) for Arm A compared with Arm B based on modified RECIST (mRECIST) for HCC.<br>- Determine the response rate for Arm A compared with Arm B based on mRECIST for HCC.<br>- Determine time-to-symptomatic progression (TSP) for Arm A compared with Arm B.<br>- Determine the Quality of Life (QoL) of patients treated in Arm A compared with Arm B.<br>- Determine the safety and tolerability of JX-594 plus BSC (Arm A) compared to BSC (Arm B).;Primary end point(s): Overall Survival;Timepoint(s) of evaluation of this end point: CT scan every six weeks until progression or death
- Secondary Outcome Measures
Name Time Method Secondary end point(s): Time-to-tumor progression, tumor response, time-to-symptomatic-progression duration, change in quality of life, safety and toxicity.;Timepoint(s) of evaluation of this end point: •Time to Tumor Progression: CT scan every six weeks until progression or death, assessed up to 21 months (average)<br>•Quality of Life: assessed up to 21 months (average)<br>•Tumor Response: CT scan every 6 weeks until progression or death, assessed up to 21 months (average)<br>•Safety profile of JX594: assessed up to 21 months (average)<br>•Time-to-symptomatic-progression: assessed up to 21 months (average)