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
1 other identifier
interventional
14
1 country
1
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for phase_1
Started Jan 2006
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
January 1, 2006
CompletedPrimary Completion
Last participant's last visit for primary outcome
July 1, 2007
CompletedStudy Completion
Last participant's last visit for all outcomes
August 1, 2007
CompletedFirst Submitted
Initial submission to the registry
February 26, 2008
CompletedFirst Posted
Study publicly available on registry
March 6, 2008
CompletedJanuary 4, 2013
February 1, 2008
1.5 years
February 26, 2008
January 3, 2013
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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
Safety evaluation throughout study participation
Secondary Outcomes (1)
Secondary objectives include determination of JX-594 pharmacokinetics, replication and shedding, immune response, and injection site tumor responses.
Study Arms (4)
1
EXPERIMENTAL1e8 pfu (plaque forming units)total dose each treatment day
2
EXPERIMENTAL3e8 pfu (plaque forming units) total dose each treatment day
3
EXPERIMENTAL1e9 pfu (plaque forming units) total dose each treatment day
4
EXPERIMENTAL3e9 pfu (plaque forming units) total dose each treatment day
Interventions
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.
Eligibility Criteria
You may qualify if:
- 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
- +1 more criteria
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Jennerex Biotherapeuticslead
- Green Cross Corporationcollaborator
Study Sites (1)
Dong-A University Hospital
Busan, 602-715, South Korea
Related Publications (1)
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. doi: 10.1016/S1470-2045(08)70107-4. Epub 2008 May 19.
PMID: 18495536DERIVED
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
David Kirn, MD
Jennerex Biotherapeutics (Jennerex, Inc.)
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- NON RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- INDUSTRY
Study Record Dates
First Submitted
February 26, 2008
First Posted
March 6, 2008
Study Start
January 1, 2006
Primary Completion
July 1, 2007
Study Completion
August 1, 2007
Last Updated
January 4, 2013
Record last verified: 2008-02