Clinical trial · Interventional
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
NCT00629759CI-TRIAL-00112003completedPhase 1ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Neoplasms, Liver | Liver Neoplasm | ONTOLOGY_EXACT | 0.98 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| JX-594: Recombinant vaccinia virus (TK-deletion plus GM-CSF) | Genetic | — | UNRESOLVED |
Design
Arms and outcomes
Arms (4)
- 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
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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
References
Publications (1)
- DERIVEDPark 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 18495536