Phase I Study of High-Dose Continuous-Infusion Recombinant Interleukin-2 and Autologous Lymphokine-Activated Killer Cells in Patients With Metastatic or Unresectable Malignant Melanoma and Renal Cell Carcinoma

Abstract

The current study was undertaken to determine the maximum tolerated dose of recombinant interleukin-2 (rIL-2) that could be administered as a continuous infusion in conjunction with autologous lymphokine-activated killer (LAK) cells. All 55 patients in this study received a priming dose of rIL-2 of 1.0 mg/m ² per day given as a continuous infusion over 4.5 days. Patients later received (days 11–16) one of three doses of rIL-2 per day (1.0, 1.25, or 1.50 mg/m ² ) in conjunction with LAK cells given on days 11, 12, and 14. Because of unacceptable toxicity occurring early in the LAK cell phase of therapy at the rIL-2 dose level of 1.50 mg/m ² , we concluded that the maximum tolerated dose of rIL-2 given as a continuous infusion with LAK cells is 1.25 mg/m ² per day. [J Natl Cancer Inst 82: 1397–1402, 1990]