Phase I Study of Percutaneous Injections of Adeno-Virus p53 Construct (ADENO-p53) for Hepatocellular Carcinoma
18 Years
N/A
Both
Liver Cancer
Trial Information
Phase I Study of Percutaneous Injections of Adeno-Virus p53 Construct (ADENO-p53) for Hepatocellular Carcinoma
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.
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
Type of Study:
Interventional
Study Design:
Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Principal Investigator
Chandra P. Belani, MD
Investigator Role:
Study Chair
Investigator Affiliation:
University of Pittsburgh
Authority:
United States: Food and Drug Administration
Study ID:
NCI-2012-02259
NCT ID:
NCT00003147
Start Date:
February 1998
Completion Date:
Related Keywords:
- Liver Cancer
- localized unresectable adult primary liver cancer
- adult primary hepatocellular carcinoma
- Liver Neoplasms
- Carcinoma, Hepatocellular
Name | Location |
|---|---|
| Albert Einstein Comprehensive Cancer Center | Bronx, New York 10461 |
| University of Pittsburgh Cancer Institute | Pittsburgh, Pennsylvania 15213 |
