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

Status

Terminated

Phases

Phase 1

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00003147

Enrollment

Registered

2004-08-24

Start date

1998-02-28

Completion date

Unknown

Last updated

2013-02-05

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Liver Cancer

Keywords

localized unresectable adult primary liver cancer, adult primary hepatocellular carcinoma

Brief summary

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.

Detailed description

OBJECTIVES: I. Determine the safety of adenovirus p53 construct (adeno-p53) in patients with hepatocellular carcinoma. II. Investigate the potential effects of intralesional adeno-p53 given by monthly percutaneous injections in these patients. OUTLINE: This is a dose escalation, multicenter study. 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.

Interventions

BIOLOGICALAd5CMV-p53 gene

Study design

Allocation

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

Inclusion criteria

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

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026