A Study of Recombinant Vaccinia Virus to Evaluate the Safety and Efficacy of a Transdermal Injection Within the Tumor of Patients With Primary or Metastatic Hepatic Carcinoma

This study has been completed.
Sponsor:
Collaborator:
Green Cross Corporation
Information provided by:
Jennerex Biotherapeutics
ClinicalTrials.gov Identifier:
NCT00629759
First received: February 26, 2008
Last updated: January 3, 2013
Last verified: February 2008

February 26, 2008
January 3, 2013
January 2006
July 2007   (final data collection date for primary 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 [ Time Frame: Safety evaluation throughout study participation ] [ Designated as safety issue: Yes ]
Same as current
Complete list of historical versions of study NCT00629759 on ClinicalTrials.gov Archive Site
Secondary objectives include determination of JX-594 pharmacokinetics, replication and shedding, immune response, and injection site tumor responses. [ Designated as safety issue: Yes ]
Same as current
Not Provided
Not Provided
 
A Study of Recombinant Vaccinia Virus to Evaluate the Safety and Efficacy of a Transdermal Injection Within the Tumor of Patients With Primary or Metastatic Hepatic Carcinoma
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

The primary purpose of this study is to determine the maximum tolerable dose (MTD) and/or the maximum feasible dose (MFD), as well as to evaluate the safety of JX-594 (Pexa-Vec) injected within hepatic carcinoma tumors.

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).

Interventional
Phase 1
Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Neoplasms, Liver
Genetic: JX-594: Recombinant vaccinia virus (TK-deletion plus GM-CSF)
The total dose is divided between 1-3 tumors located within the liver. Patients are treated with JX-594 once every 3 weeks until progression at the site(s) of injection or until the patient has received a maximum of 4 treatments.
  • Experimental: 1
    1e8 pfu (plaque forming units)total dose each treatment day
    Intervention: Genetic: JX-594: Recombinant vaccinia virus (TK-deletion plus GM-CSF)
  • Experimental: 2
    3e8 pfu (plaque forming units) total dose each treatment day
    Intervention: Genetic: JX-594: Recombinant vaccinia virus (TK-deletion plus GM-CSF)
  • Experimental: 3
    1e9 pfu (plaque forming units) total dose each treatment day
    Intervention: Genetic: JX-594: Recombinant vaccinia virus (TK-deletion plus GM-CSF)
  • Experimental: 4
    3e9 pfu (plaque forming units) total dose each treatment day
    Intervention: Genetic: JX-594: Recombinant vaccinia virus (TK-deletion plus GM-CSF)
Park BH, Hwang T, Liu TC, Sze DY, Kim JS, Kwon HC, Oh SY, Han SY, Yoon JH, Hong SH, Moon A, Speth K, Park C, Ahn YJ, Daneshmand M, Rhee BG, Pinedo HM, Bell JC, Kirn DH. Use of a targeted oncolytic poxvirus, JX-594, in patients with refractory primary or metastatic liver cancer: a phase I trial. Lancet Oncol. 2008 Jun;9(6):533-42. Epub 2008 May 19.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
14
August 2007
July 2007   (final data collection date for primary outcome measure)

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 enrollment
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
Korea, Republic of
 
NCT00629759
JX594-IT-HEP001
Yes
David Kirn, MD, President and CEO, Jennerex, Inc. (Jennerex Biotherapeutics)
Jennerex Biotherapeutics
Green Cross Corporation
Study Director: David Kirn, MD Jennerex Biotherapeutics (Jennerex, Inc.)
Jennerex Biotherapeutics
February 2008

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP