A Study of Recombinant Vaccinia Virus to Treat Unresectable Primary Hepatocellular Carcinoma

Completed · Phase 2

Conditions studied: Carcinoma, Hepatocellular

In brief

The purpose of this research study is to determine whether JX-594 (Pexa-Vec) has significant anti-tumoral activity and tolerability in primary hepatocellular carcinoma and to determine the dose to be used in further testing.

Key facts

Study ID

NCT00554372

Run by

Jennerex Biotherapeutics

People needed

30

Starts

2008-08-01

Expected to finish

2013-02-01

Last updated by the study team

2026-06-16

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Histological confirmation or clinical/laboratory diagnosis of primary hepatocellular carcinoma (HCC)
• Cancer is not surgically resectable for cure
• Child Pugh A or B
• Tumor progression during or after at least one prior HCC treatment regimen (Note: If standard HCC therapies are either medically contraindicated or patient has refused those treatments, the patient may be eligible for this study)
• Performance Score: KPS score of ≥ 70
• Anticipated survival of at least 16 weeks
• Total bilirubin ≤ 2.5 x ULN
• AST, ALT < 5.0 x ULN
• WBC > 2,500 cells/mm3 and < 50,000 cells/mm3 (GCSF treatment allowed)
• ANC > 1,250 cells/mm3 (GCSF treatment allowed)
• Hemoglobin ≥ 9 g/dL (RBC transfusion allowed)
• Platelet count ≥ 50,000 plts/mm3
• Acceptable coagulation status: INR ≤ 1.5 x ULN
• Acceptable kidney function: Serum creatinine < 2.0 mg/dL
• If patients are diabetic or have a screening random glucose > 160 mg/dL, a fasting glucose must be done and patients must be WNL or Grade 1 in order to be eligible for the study
• For patients who are sexually active: able and willing to abstain from sex during treatment period and for 3 weeks following treatment, and use an acceptable method of birth control for 3 months after last injection with JX-594
• Able/willing to sign an IRB/IEC/REB-approved written consent form
• Able and willing to comply with study procedures and follow-up examinations, including compliance with the "Infection Control Guidelines for Patients" (in written consent form)

You may not qualify if…

• Current, known extra-hepatic tumors that, in the investigator's medical opinion, are likely to result in significant morbidity or mortality within the next 16 weeks.
• Pregnant or nursing an infant
• Known infection with HIV
• Clinically significant active infection or uncontrolled medical condition considered high risk for investigational new drug treatment
• 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
• Liver tumors in a location that would potentially result in significant clinical adverse effects if post-treatment tumor swelling were to occur (e.g. tumors impinging on the biliary tract that could affect drainage)
• Severe or unstable cardiac disease
• Current, known CNS malignancy
• Anti-cancer therapy (e.g. RFA, TACE, PEIT, radioembolization, chemotherapy, surgery, or an investigational drug, etc.) within 4 weeks prior to first treatment
• Absolute contraindication to undergoing MRI scanning
• Experienced a severe systemic reaction or side-effect as a result of a previous smallpox vaccination
• 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).
• Inability or unwillingness to give informed consent or comply with the procedures required in the protocol
• 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

Where it is running

• Moores UCSD Cancer Center — La Jolla, California, United States
• Mayo Clinic — Rochester, Minnesota, United States
• Billings Clinic Cancer Center — Billings, Montana, United States
• The Ohio State University — Columbus, Ohio, United States
• University of Pittsburgh Medical Center - Liver Cancer Center — Pittsburgh, Pennsylvania, United States
• McMaster University Medical Centre — Hamilton, Ontario, Canada
• Pusan National University Hospital — Busan, South Korea
• Samsung Medical Center — Seoul, South Korea
• Shin Chon Severance Hospital / Yonsei University Medical Center — Seoul, South Korea

Full record on ClinicalTrials.gov

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