Gene Therapy in Treating Patients With Cancer of The Liver
- Conditions
- Liver Cancer
- Registration Number
- NCT00003147
- Lead Sponsor
- National Cancer Institute (NCI)
- 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.
Recruitment & Eligibility
- Status
- TERMINATED
- Sex
- All
- Target Recruitment
- 30
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (2)
Albert Einstein Comprehensive Cancer Center
🇺🇸Bronx, New York, United States
University of Pittsburgh Cancer Institute
🇺🇸Pittsburgh, Pennsylvania, United States
Albert Einstein Comprehensive Cancer Center🇺🇸Bronx, New York, United States