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

Phase 2
18 Years
Not Enrolling
Liver Cancer

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Trial Information

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

OBJECTIVES: I. Evaluate the immunological response to doxorubicin and protracted recombinant
interleukin-2 in terms of alterations in hepatocellular carcinoma specific cytotoxic T cells
detectable in peripheral blood in patients with unresectable hepatocellular carcinoma. II.
Determine the toxicity of this treatment regimen in this patient population. III. Determine
the tumor response to this regimen in terms of changes in alpha fetoprotein and tumor size
measured by CT scan in these patients. IV. Determine the progression free survival and
overall survival of this patient population treated with this regimen. V. Determine the
correlation between immunological response, tumor response, progression free survival and
overall survival in these patients.

OUTLINE: Patients receive doxorubicin IV over 3-5 minutes on day 1 and recombinant
interleukin-2 (IL-2) IV continuously beginning on day 5 and continuing until day 57.
Patients achieving partial or complete clinical response regardless of immunological
response and patients with stable disease and an immunological response continue on IL-2
therapy continuously until day 92. Patients with stable disease and no immunological
response receive an additional dose of doxorubicin on day 57 and then continue on IL-2 until
day 92. Patients who are clinically eligible with progressive disease and an immunological
response continue IL-2 therapy as above. Patients are followed at 2 weeks and then monthly

PROJECTED ACCRUAL: A total of 24-30 patients will be accrued for this study within
approximately 3 years.

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

Type of Study:


Study Design:

Intervention Model: Single Group Assignment, Primary Purpose: Treatment

Principal Investigator

Lawrence P. Leichman, MD

Investigator Role:

Study Chair

Investigator Affiliation:

Albany Medical College


United States: Food and Drug Administration

Study ID:




Start Date:

July 1999

Completion Date:

May 2001

Related Keywords:

  • Liver Cancer
  • localized unresectable adult primary liver cancer
  • recurrent adult primary liver cancer
  • adult primary hepatocellular carcinoma
  • Liver Neoplasms
  • Carcinoma, Hepatocellular



Roswell Park Cancer Institute Buffalo, New York  14263