Ignite Creation Date:
2025-12-24 @ 2:55 PM
Ignite Modification Date:
2026-01-10 @ 11:33 PM
Study NCT ID:
NCT00629759
Status:
COMPLETED
Last Update Posted:
2013-01-04
First Post:
2008-02-26
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
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
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D008113', 'term': 'Liver Neoplasms'}, {'id': 'D006528', 'term': 'Carcinoma, Hepatocellular'}, {'id': 'D014615', 'term': 'Vaccinia'}], 'ancestors': [{'id': 'D004067', 'term': 'Digestive System Neoplasms'}, {'id': 'D009371', 'term': 'Neoplasms by Site'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D004066', 'term': 'Digestive System Diseases'}, {'id': 'D008107', 'term': 'Liver Diseases'}, {'id': 'D000230', 'term': 'Adenocarcinoma'}, {'id': 'D002277', 'term': 'Carcinoma'}, {'id': 'D009375', 'term': 'Neoplasms, Glandular and Epithelial'}, {'id': 'D009370', 'term': 'Neoplasms by Histologic Type'}, {'id': 'D011213', 'term': 'Poxviridae Infections'}, {'id': 'D004266', 'term': 'DNA Virus Infections'}, {'id': 'D014777', 'term': 'Virus Diseases'}, {'id': 'D007239', 'term': 'Infections'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D016178', 'term': 'Granulocyte-Macrophage Colony-Stimulating Factor'}], 'ancestors': [{'id': 'D003115', 'term': 'Colony-Stimulating Factors'}, {'id': 'D006023', 'term': 'Glycoproteins'}, {'id': 'D006001', 'term': 'Glycoconjugates'}, {'id': 'D002241', 'term': 'Carbohydrates'}, {'id': 'D016298', 'term': 'Hematopoietic Cell Growth Factors'}, {'id': 'D016207', 'term': 'Cytokines'}, {'id': 'D036341', 'term': 'Intercellular Signaling Peptides and Proteins'}, {'id': 'D010455', 'term': 'Peptides'}, {'id': 'D000602', 'term': 'Amino Acids, Peptides, and Proteins'}, {'id': 'D011506', 'term': 'Proteins'}, {'id': 'D001685', 'term': 'Biological Factors'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 14}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2006-01'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2008-02', 'completionDateStruct': {'date': '2007-08', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2013-01-03', 'studyFirstSubmitDate': '2008-02-26', 'studyFirstSubmitQcDate': '2008-02-26', 'lastUpdatePostDateStruct': {'date': '2013-01-04', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2008-03-06', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2007-07', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'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', 'timeFrame': 'Safety evaluation throughout study participation'}], 'secondaryOutcomes': [{'measure': 'Secondary objectives include determination of JX-594 pharmacokinetics, replication and shedding, immune response, and injection site tumor responses.'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['Jennerex', 'unresectable liver tumors', 'primary liver cancer', 'metastatic liver cancer', 'oncolytic virus', 'vaccinia virus', 'Pexa-Vec'], 'conditions': ['Neoplasms, Liver']}, 'referencesModule': {'references': [{'pmid': '18495536', 'type': 'DERIVED', 'citation': '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.'}], 'seeAlsoLinks': [{'url': 'http://www.jennerex.com', 'label': 'Sponsor company website'}]}, 'descriptionModule': {'briefSummary': '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.', 'detailedDescription': '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).'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Age ≥ 18 years\n* 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\n* Tumor progression despite undergoing regular treatment such as surgery, transarterial chemoembolization, chemotherapy, and radiotherapy\n* Performance score: Karnofsky Performance Score (KPS) ≥70\n* Expected survival of at least 16 weeks\n* For patients who are sexually active, able and willing to use contraceptives for a three month period during and after taking JX-594\n* WBC \\> 3,500 cells/mm3\n* ANC \\> 1,500 cells/mm3\n* Hemoglobin \\> 10g/dL\n* Platelet count \\> 75,000 plts/mm3\n* Serum creatinine \\< 1.5 mg/dL\n* AST, ALT \\< 2.5 x ULN\n* Total bilirubin ≤ 2.0 mg/dL\n* In patients with primary HCC, Child Pugh A or B\n* Able/willing to sign an IRB/IEC/REB-approved written consent form\n* Able and willing to comply with study procedures and follow-up examinations\n\nExclusion Criteria:\n\n* Pregnant or nursing an infant\n* Known infection with HIV\n* Clinically significant active infection or uncontrolled medical condition considered high risk for investigational new drug treatment\n* 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)\n* Patients with household contacts with significant immunodeficiency\n* History of exfoliative skin condition (e.g. severe eczema, ectopic dermatitis, or similar skin disorder) that at some stage has required systemic therapy\n* Severe or unstable cardiac disease\n* Use of adrenal cortical hormone drug or immunosuppressant within four weeks of study enrollment'}, 'identificationModule': {'nctId': 'NCT00629759', 'briefTitle': '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', 'organization': {'class': 'INDUSTRY', 'fullName': 'Jennerex Biotherapeutics'}, 'officialTitle': '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', 'orgStudyIdInfo': {'id': 'JX594-IT-HEP001'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': '1', 'description': '1e8 pfu (plaque forming units)total dose each treatment day', 'interventionNames': ['Genetic: JX-594: Recombinant vaccinia virus (TK-deletion plus GM-CSF)']}, {'type': 'EXPERIMENTAL', 'label': '2', 'description': '3e8 pfu (plaque forming units) total dose each treatment day', 'interventionNames': ['Genetic: JX-594: Recombinant vaccinia virus (TK-deletion plus GM-CSF)']}, {'type': 'EXPERIMENTAL', 'label': '3', 'description': '1e9 pfu (plaque forming units) total dose each treatment day', 'interventionNames': ['Genetic: JX-594: Recombinant vaccinia virus (TK-deletion plus GM-CSF)']}, {'type': 'EXPERIMENTAL', 'label': '4', 'description': '3e9 pfu (plaque forming units) total dose each treatment day', 'interventionNames': ['Genetic: JX-594: Recombinant vaccinia virus (TK-deletion plus GM-CSF)']}], 'interventions': [{'name': 'JX-594: Recombinant vaccinia virus (TK-deletion plus GM-CSF)', 'type': 'GENETIC', 'description': '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.', 'armGroupLabels': ['1', '2', '3', '4']}]}, 'contactsLocationsModule': {'locations': [{'zip': '602-715', 'city': 'Busan', 'country': 'South Korea', 'facility': 'Dong-A University Hospital', 'geoPoint': {'lat': 35.10168, 'lon': 129.03004}}], 'overallOfficials': [{'name': 'David Kirn, MD', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Jennerex Biotherapeutics (Jennerex, Inc.)'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Jennerex Biotherapeutics', 'class': 'INDUSTRY'}, 'collaborators': [{'name': 'Green Cross Corporation', 'class': 'INDUSTRY'}], 'responsibleParty': {'oldNameTitle': 'David Kirn, MD, President and CEO', 'oldOrganization': 'Jennerex, Inc. (Jennerex Biotherapeutics)'}}}}