Phase I Study of Percutaneous Injections of Adeno-Virus p53 Construct (ADENO-p53) for Hepatocellular Carcinoma
Ad5CMV-p53 gene
Adenocarcinoma+8
+ Carcinoma
+ Digestive System Diseases
Treatment Study
Summary
Study start date: February 1, 1998
Actual date on which the first participant was enrolled.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.
Protocol
This section provides details of the study plan, including how the study is designed and what the study is measuring.30 patients to be enrolled
Total number of participants that the clinical trial aims to recruit.Treatment Study
Eligibility
Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.Any sex
Biological sex of participants that are eligible to enroll.Over 18 Years
Range of ages for which participants are eligible to join.Healthy volunteers not allowed
If individuals who are healthy and do not have the condition being studied can participate.Conditions
Pathology
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
Study Plan
Find out more about all the medication administered in this study, their detailed description and what they involve.One single intervention group is designated in this study
This study does not include a placebo group
Treatment Groups
Group I
ExperimentalStudy Centers
These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.This study has 2 locations
Albert Einstein Comprehensive Cancer Center
The Bronx, United StatesOpen Albert Einstein Comprehensive Cancer Center in Google MapsUniversity of Pittsburgh Cancer Institute
Pittsburgh, United States