A Low Dose Schedule of Adriamycin and Protracted Infusion of Recombinant Interleukin-2: A Phase II Study of Immunotherapy in Unresectable Hepatocellular Carcinoma

Inclusion Criteria

DISEASE CHARACTERISTICS: Histologically proven hepatocellular carcinoma OR Elevation of
alpha fetoprotein (AFP) (greater than 400 ng/mL) in the presence of a space occupying
lesion in the liver with known chronic liver disease Lesion must be easily biopsied
Unresectable disease Bidimensionally measurable disease by radiography OR Evaluable
disease with elevated AFP Okuda stage I disease Tumor size less than 50% of liver No
ascites Albumin greater than 3 g/dL Bilirubin less than 2 mg/dL OR Okuda stage II disease
Bilirubin as in stage I If ascites present, albumin must be greater than 3 g/dL

PATIENT CHARACTERISTICS: Age: 18 and over Performance status: ECOG 0-2 Life expectancy: At
least 12 weeks Hematopoietic: Hemoglobin at least 9.0 g/dL Neutrophil count at least
1,500/mm3 Platelet count at least 80,000/mm3 Hepatic: See Disease Characteristics
SGOT/SGPT no greater than 4 times upper limit of normal Any cause of underlying liver
disease including hepatitis B or C allowed Renal: Creatinine no greater than 2.0 mg/dL
Cardiovascular: No poor cardiac function No myocardial infarction within the past 6 months
No poorly controlled arrhythmia No congestive heart failure LVEF at least 45% by MUGA
Other: No active hepatic encephalopathy No other active malignancies except curatively
treated nonmelanoma skin cancer or carcinoma in situ of the cervix HIV negative No
immunodeficiency Not pregnant or nursing Negative pregnancy test Fertile patients must use
effective contraception

PRIOR CONCURRENT THERAPY: Biologic therapy: At least 6 weeks since prior immunotherapy,
including interferon Chemotherapy: No prior systemic or intra arterial doxorubicin At
least 6 weeks since prior chemotherapy Endocrine therapy: Not specified Radiotherapy: Not
specified Surgery: See Disease Characteristics Other: At least 4 weeks since prior
investigational therapy