ALPHA INTERFERON, TUMOR INFILTRATING LYMPHOCYTES, AND INTERLEUKIN-2 IN THE TREATMENT OF CANCER
OBJECTIVES: I. Determine the response rate and failure-free survival in patients with
metastatic cancer (preferably melanoma or renal cell) treated with autologous tumor
infiltrating lymphocytes (TIL), interferon alfa (IFN-A), and interleukin-2 (IL-2). II.
Describe the toxic effects and costs associated with this therapy to assess risk benefit and
cost benefit. III. Assess the relative value of administering low- or high-dose TIL, as well
as the value of administering IFN-A before TIL, IL-2 with TIL, or cimetidine with TIL.
OUTLINE: This is a multicenter study. Patients are stratified according to center, tumor
infiltrating lymphocyte (TIL) dose (low vs high), and medical condition suitable for
interferon alfa (IFN-A)/interleukin-2 (IL-2) (yes vs no). Patients are assigned to one of
two treatment regimens based on entry criteria. Regimen A (preferred): Patients meeting the
preferred entry criteria receive IFN-A subcutaneously on days 1-4, TIL expanded in vitro
with IL-2 IV on day 5, and IL-2 IV continuously over 72 hours following TIL infusion.
Regimen B: All other patients receive TIL infusion once followed by oral cimetidine every 6
hours for 4 weeks. Treatment repeats in both regimens every 3-6 weeks in the absence of
disease progression and according to TIL availability. Patients are followed every 6 months.
PROJECTED ACCRUAL: A total of 20-30 patients with melanoma and 20-30 patients with renal
cell carcinoma will be accrued for this study.
Primary Purpose: Treatment
Robert O. Dillman, MD, FACP
Cancer Biotherapy Research Group
United States: Food and Drug Administration
|Hoag Memorial Hospital Presbyterian||Newport Beach, California 92658|