Clinical trial · Interventional
Gene Therapy in Treating Patients With Cancer of The Liver
Phase I Study of Percutaneous Injections of Adeno-Virus p53 Construct (ADENO-p53) for Hepatocellular Carcinoma
NCT00003147CI-TRIAL-00009319terminatedPhase 1ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Why stopped (as posted): Administratively complete.
Summary
Brief summary (as posted)
Phase I trial to study the effectiveness of gene therapy with the p53 gene in treating patients who have cancer of the liver that cannot be surgically removed. Inserting the p53 gene into a person's tumor may improve the body's ability to fight liver cancer.
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 |
|---|---|---|---|
| Liver Cancer | Malignant Liver Neoplasm | CURATED_EXACT | 0.92 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Ad5CMV-p53 gene | Biological | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Arm I
- description
- Patients receive adenovirus p53 construct by percutaneous injection to a maximum of two lesions on day 1. Treatment is repeated every 28 days for up to 6 courses. In the absence of dose-limiting toxicity (DLT) in the first cohort of 6 patients treated, subsequent cohorts of 6 patients each receive escalating doses of the drug on the same schedule. If DLT occurs in 2 of 6 patients at a given dose level, then dose escalation ceases and that dose is declared the maximum tolerated dose. Study treatment may continue in the absence of disease progression and unacceptable adverse events.
- interventionNames
- Biological: Ad5CMV-p53 gene
Primary outcomes (0)
[]Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
DISEASE CHARACTERISTICS: * Histologically confirmed unresectable hepatocellular carcinoma (HCC) or highly suspicious for HCC based on CT scan and elevated alfafetoprotein * Measurable disease by abdominal CT scan Accessible (peripheral) lesions * No metastatic disease PATIENT CHARACTERISTICS: * Age: Over 18 * Performance status: ECOG 0-2 * Life expectancy: At least 12 weeks * Platelet count at least 60,000/mm3 * Absolute neutrophil count greater than 1,500/mm3 * Prothrombin time of no greater than 16 seconds after administration of fresh frozen plasma * Bilirubin no greater than 3.0 mg/dL * Creatinine less than 1.5 mg/dL * Child's class A or B cirrhosis eligible * No uncontrolled infection Not pregnant or breast feeding * No unstable or severe intercurrent medical condition PRIOR CONCURRENT THERAPY: * At least 4 weeks since prior chemotherapy * At least 4 weeks since prior radiation therapy * No prior hepatic transplantation * No more than 1 prior systemic regimen for hepatocellular carcinoma allowed * No concurrent therapy with other investigational agents * No prior gene therapy * No prior intralesional therapy
References
Publications (0)
Data not yet available
No reference posted for this study.