Know Cancer

forgot password

Phase 1 Clinical Study for Evaluating the Safety and Efficacy of a Transdermal Injection of JX-594 (Thymidine Kinase (-)/GM-CSF(+) Vaccinia Virus) Within the Tumor of Patients With Hepatic Carcinoma

Phase 1
18 Years
Not Enrolling
Neoplasms, Liver

Thank you

Trial Information

Phase 1 Clinical Study for Evaluating the Safety and Efficacy of a Transdermal Injection of JX-594 (Thymidine Kinase (-)/GM-CSF(+) Vaccinia Virus) Within the Tumor of Patients With Hepatic Carcinoma

Patients are treated with JX-594 once every three weeks until progression at the site(s) of
injection or until the patient has received a maximum of 4 treatments; four additional
cycles can be administered to patients with an objective response of the injected tumor(s)
(i.e. 8 total treatments possible). Study dose levels are 1e8 pfu, 3e8 pfu, 1e9 pfu and 3e9
pfu per treatment. Standard Phase I dose-escalation guidelines are used, with 2-6 patients
enrolled per cohort (3 if no dose-limiting toxicities are reported).

Inclusion Criteria:

- Age ≥ 18 years

- Patients with hepatic carcinoma (primary or metastatic) clinically or histologically
confirmed to have tumors (≤10cm maximum diameter) that are progressing (refractory to
standard treatment) despite regular treatment and that can be transdermally accessed
by an injection needle in an imaging-guided procedure

- Tumor progression despite undergoing regular treatment such as surgery, transarterial
chemoembolization, chemotherapy, and radiotherapy

- Performance score: Karnofsky Performance Score (KPS) ≥70

- Expected survival of at least 16 weeks

- For patients who are sexually active, able and willing to use contraceptives for a
three month period during and after taking JX-594

- WBC > 3,500 cells/mm3

- ANC > 1,500 cells/mm3

- Hemoglobin > 10g/dL

- Platelet count > 75,000 plts/mm3

- Serum creatinine < 1.5 mg/dL

- AST, ALT < 2.5 x ULN

- Total bilirubin ≤ 2.0 mg/dL

- In patients with primary HCC, Child Pugh A or B

- Able/willing to sign an IRB/IEC/REB-approved written consent form

- Able and willing to comply with study procedures and follow-up examinations

Exclusion Criteria:

- 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)

- Patients with household contacts with significant immunodeficiency

- History of exfoliative skin condition (e.g. severe eczema, ectopic dermatitis, or
similar skin disorder) that at some stage has required systemic therapy

- Severe or unstable cardiac disease

- Use of adrenal cortical hormone drug or immunosuppressant within four weeks of study

Type of Study:


Study Design:

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

To determine the maximum tolerable dose (MTD) and/or the maximum feasible dose (MFD), as well as to evaluate the safety of JX-594 injected within unresectable solid tumor(s) within the liver

Outcome Time Frame:

Safety evaluation throughout study participation

Safety Issue:


Principal Investigator

David Kirn, MD

Investigator Role:

Study Director

Investigator Affiliation:

Jennerex Biotherapeutics (Jennerex, Inc.)


South Korea: Korea Food and Drug Administration (KFDA)

Study ID:




Start Date:

January 2006

Completion Date:

August 2007

Related Keywords:

  • Neoplasms, Liver
  • Jennerex
  • unresectable liver tumors
  • primary liver cancer
  • metastatic liver cancer
  • oncolytic virus
  • vaccinia virus
  • Pexa-Vec
  • Neoplasms
  • Carcinoma
  • Liver Neoplasms
  • Vaccinia
  • Carcinoma, Hepatocellular