EUCTR2012-000591-42-ESActive, not recruitingNot Applicable
A Single-Arm, Open-Label Phase 2 Study of JX 594 (Thymidine Kinase-Deactivated Vaccinia Virus plus GM-CSF) Administered by Weekly Intravenous (IV) Infusions in Sorafenib-naïve Patients with Advanced Hepatocellular Carcinoma (HCC).
Jennerex, Inc0 sites24 target enrollmentStarted: July 26, 2012Last updated:
Conditions
Trial Snapshot
- Phase
- Not Applicable
- Status
- Active, not recruiting
- Sponsor
- Enrollment
- 24
Study Overview
Brief Summary
No summary available.
Study Design
- Study Type
- Interventional clinical trial of medicinal product
Eligibility Criteria
- Sex
- All
Inclusion Criteria
- •1. Advanced HCC (excluding fibrolamellar carcinoma and hepatoblastoma): Patients are not eligible for, or had disease progression after, local-regional therapy (e.g., surgery, TACE, RFA, ethanol injection, e.g., BCLC Grade B or C [AASLD guidelines])
- •2. Histological/cytological confirmation or clinical/laboratory diagnosis of primary HCC [clinical/laboratory diagnosis is defined according to the AASLD guidelines as the following:
- •a. nodules larger than 2 cm in cirrhotic livers: with typical vascular features on a dynamic imaging technique (CT, contrast US or non-contrast MRI), or AFP >200 ng/ml;
- •b. nodules between 1?2 cm in cirrhotic livers: with typical vascular features on 2 dynamic studies.]
- •3. Child-Pugh Class A; or Child-Pugh Class B7 without clinically significant ascites
- •4. Platelet count ?50,000 plts/mm3
- •5. INR ?1.7
- •6. Measurable tumor (at least one tumor with ?1 cm LD of contrast-enhancement during the arterial phase on CT scanning)
- •7. Expected survival of approximately 12 weeks or longer
- •8. Eastern Cooperative Oncology Group (ECOG) performance status 0, 1, or 2
- •9. Aged ?18 years old
- •10. WBC count ?2,000 cells/mm3 and ?50,000 cells/mm3
- •11. Absolute neutrophil count (ANC) ?1,200 cells/mm3
- •12. Lymphocytes ?500 cells/mm3
- •13. Hemoglobin ?10 g/dL (correction with transfusion allowed)
- •14. Adequate liver function (albumin ?2.8 g/dL, total bilirubin ?3 mg/dL; ALT, AST ?5 x ULN)
- •15. Serum chemistries within normal limits or Grade 1 (excluding alkaline phosphatase)
- •16. For patients who are sexually active: patient must be able and willing to abstain for a minimum of 15 days after each treatment and subsequently use barrier method during JX 594 treatment period and for at least 6 weeks after the last JX 594 treatment
- •17. Written informed consent obtained from the patient
- •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 18
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 3
Exclusion Criteria
- •1. Serum creatinine >2.0 mg/dL and/or creatinine clearance is <60 mL/min according to Cockroft-Gault formula
- •2. Significant immunodeficiency due to underlying illness (e.g., HIV/AIDS) and/or medication
- •3. History of severe exfoliative skin condition
- •4. Tumor(s) invading a major vascular structure
- •5. Clinically significant and/or rapidly accumulating ascites, pericardial and/or pleural effusions
- •6. Severe or unstable cardiac disease, including significant coronary artery disease within the preceding 12 months, unless well-controlled and on stable medical therapy for at least 3 months
- •7. Viable central nervous system (CNS) malignancy associated with clinical symptoms
- •8. Received sorafenib as previous treatment for HCC for more than 14 days
- •9. Received anti-cancer therapy within 4 weeks prior to first treatment (6 weeks in case of mitomycin C or nitrosoureas)
- •10. Participation in any other research protocol involving an investigational medicinal product (IMP) within 2 months prior to first treatment
- •11. Other medical condition or laboratory abnormality or active infection that in the judgment of the Principal Investigator may increase the risk associated with study participation or may interfere with interpretation of study results and/or otherwise make the patient inappropriate for entry into this study
- •12. Use of interferon/pegylated interferon (PEG-IFN) or ribavirin that cannot be discontinued within 14 days prior to any JX 594 dose.
- •13. Significant bleeding event within the last 12 months based on investigator assessment.
- •14. Inability to receive IV iodinated contrast agents for CT scanning due to documented history of iodinated contrast allergy unless controlled by medical intervention
- •15. Pregnant or nursing an infant
- •16. Experienced a severe systemic reaction or side-effect as a result of a previous smallpox vaccination
- •17. Patient unable or unwilling to comply with the protocol requirements
Investigators
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