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:
Jennerex Biotherapeutics
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
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Purpose
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.
| Condition | Intervention | Phase |
|---|---|---|
|
Neoplasms, Liver |
Genetic: JX-594: Recombinant vaccinia virus (TK-deletion plus GM-CSF) |
Phase 1 |
| Study Type: | Interventional |
| Study Design: | Allocation: Non-Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment |
| Official Title: | 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 |
Resource links provided by NLM:
Further study details as provided by Jennerex Biotherapeutics:
Primary Outcome Measures:
- 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 ]
Secondary Outcome Measures:
- Secondary objectives include determination of JX-594 pharmacokinetics, replication and shedding, immune response, and injection site tumor responses. [ Designated as safety issue: Yes ]
| Enrollment: | 14 |
| Study Start Date: | January 2006 |
| Study Completion Date: | August 2007 |
| Primary Completion Date: | July 2007 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Experimental: 1
1e8 pfu (plaque forming units)total dose each treatment day
|
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: 2
3e8 pfu (plaque forming units) total dose each treatment day
|
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: 3
1e9 pfu (plaque forming units) total dose each treatment day
|
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: 4
3e9 pfu (plaque forming units) total dose each treatment day
|
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.
|
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 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).
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Criteria
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
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00629759
Locations
| Korea, Republic of | |
| Dong-A University Hospital | |
| Busan, Korea, Republic of, 602-715 | |
Sponsors and Collaborators
Jennerex Biotherapeutics
Green Cross Corporation
Investigators
| Study Director: | David Kirn, MD | Jennerex Biotherapeutics (Jennerex, Inc.) |
More Information
Additional Information:
No publications provided by Jennerex Biotherapeutics
Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
| Responsible Party: | David Kirn, MD, President and CEO, Jennerex, Inc. (Jennerex Biotherapeutics) |
| ClinicalTrials.gov Identifier: | NCT00629759 History of Changes |
| Other Study ID Numbers: | JX594-IT-HEP001 |
| Study First Received: | February 26, 2008 |
| Last Updated: | January 3, 2013 |
| Health Authority: | South Korea: Korea Food and Drug Administration (KFDA) |
Keywords provided by Jennerex Biotherapeutics:
|
Jennerex unresectable liver tumors primary liver cancer metastatic liver cancer |
oncolytic virus vaccinia virus Pexa-Vec |
Additional relevant MeSH terms:
|
Neoplasms Carcinoma Liver Neoplasms Vaccinia Carcinoma, Hepatocellular Neoplasms, Glandular and Epithelial Neoplasms by Histologic Type Digestive System Neoplasms |
Neoplasms by Site Digestive System Diseases Liver Diseases Poxviridae Infections DNA Virus Infections Virus Diseases Adenocarcinoma |
ClinicalTrials.gov processed this record on May 21, 2013