Interleukin‐2: Use in solid tumors

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Abstract
Recombinant interleukin‐2 (rIL‐2) is a cytokine that has a central immunoregulatory role in controlling T cell function and growth. Clinical trials of rIL‐2 regimens in various solid tumors have been initiated, and 337 patients at the Cleveland Clinic Foundation have been treated in a sequence of trials. The studies have involved rIL‐2 or poly‐ethylene‐glycol conjugated rIL‐2 (PEG‐IL‐2) as single agents, combinations of rIL‐2 with recombinant interferon alpha, IL‐4, or doxorubicin, and trials of rIL‐2 with tumor infiltrating lymphocytes (TILs). These studies are summarized and involve Phase I or Phase II investigations in patients with renal cell carcinoma (191 patients), malignant melanoma (49 patients) or miscellaneous solid tumors (97 patients). Response rates in each category, respectively, were 12%, 20% and 2%. Toxicity varied depending on the regimen and generally reflected the dose and schedule of rIL‐2 being employed. This series of clinical studies demonstrates the role of rIL‐2 in various malignancies and documents the activity in patients with malignant melanoma and renal cell carcinoma. Additional studies to investigate potential mechanisms of antitumor activity and response determinants are underway.