Phase I Study of Percutaneous Injections of Adeno-Virus p53 Construct (ADENO-p53) for Hepatocellular Carcinoma

Fecha de inicio: 1 de febrero de 1998

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