A Phase 2a Study of Modified Vaccinia Virus to Treat Sorafenib-naïve Advanced Liver Cancer

Status:	Completed
Conditions:	Liver Cancer
Therapuetic Areas:	Oncology
Healthy:	No
Age Range:	18 - Any
Updated:	4/21/2016
Start Date:	June 2012
End Date:	June 2013

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)

This study is to determine how effectively JX-594 (Pexa-Vec) will prolong life in patients
with advanced Hepatocellular Carcinoma (HCC) who have not been previously treated with
sorafenib, and the safe administration of JX-594 in five weekly IV infusions.

KEY Inclusion Criteria:

- Histologic or cytologic confirmation of advanced primary hepatocellular carcinoma
(HCC)

- Measurable tumor (at least one tumor with ≥1 cm LD of contrast-enhancement during the
arterial phase on CT scanning)

- ECOG performance status 0, 1 or 2

- Child-Pugh Class A; or Child-Pugh Class B7 without clinically significant ascites

- Platelet count ≥50,000 plts/mm3

- WBC count ≥2,000 cells/mm3 and ≤50,000 cells/mm3

- Hemoglobin ≥10 g/dL

- Adequate liver function

KEY Exclusion Criteria:

- Received sorafenib as previous treatment for HCC for more than 14 days

- History of severe exfoliative skin condition (e.g., eczema or atopic dermatitis
requiring systemic therapy for > 4 weeks)

- Prior treatment with JX-594

- 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

- Significant bleeding event within the last 12 months.

We found this trial at

sites

University of Texas Health Science Center at San Antonio

4502 Medical Drive
San Antonio, Texas 78284

(210) 567-7000