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
Overview
- Phase
- Phase 1
- Intervention
- Not specified
- Conditions
- Neoplasms, Liver
- Sponsor
- Jennerex Biotherapeutics
- Enrollment
- 14
- Locations
- 1
- Primary Endpoint
- 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
- Status
- Completed
- Last Updated
- 13 years ago
Overview
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.
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).
Investigators
Eligibility 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
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
Outcomes
Primary Outcomes
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
Secondary Outcomes
- Secondary objectives include determination of JX-594 pharmacokinetics, replication and shedding, immune response, and injection site tumor responses.