Overview

Doxorubicin and Interleukin-2 in Treating Patients With Liver Cancer That Cannot Be Removed by Surgery

Status:
Completed

Trial end date:
2001-05-01

Target enrollment:
0

Participant gender:
All

Summary

RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Interleukin-2 may stimulate a person's white blood cells to kill liver cancer cells. PURPOSE: Phase II trial to study the effectiveness of doxorubicin and interleukin- 2 in treating patients who have liver cancer that cannot be removed by surgery.

Phase:

Phase 2

Accepts Healthy Volunteers?

Details

Lead Sponsor:

Roswell Park Cancer Institute

Treatments:

Aldesleukin
Doxorubicin
Interleukin-2
Liposomal doxorubicin

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