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.
Intervention Model: Single Group Assignment, Primary Purpose: Treatment
Lawrence P. Leichman, MD
Albany Medical College
United States: Food and Drug Administration
|Roswell Park Cancer Institute||Buffalo, New York 14263|