Status:
COMPLETED
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
Lead Sponsor:
Jennerex Biotherapeutics
Collaborating Sponsors:
Green Cross Corporation
Conditions:
Neoplasms, Liver
Eligibility:
All Genders
18+ years
Phase:
PHASE1
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 hepati...
Detailed Description
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 adminis...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
January 1 2006
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
August 1 2007
Estimated Enrollment :
14 Patients enrolled
Trial Details
Trial ID
NCT00629759
Start Date
January 1 2006
End Date
August 1 2007
Last Update
January 4 2013
Active Locations (1)
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1
Dong-A University Hospital
Busan, South Korea, 602-715