Randomized study of interleukin 2 (IL-2) alone vs IL-2 plus lymphokine-activated killer cells for treatment of melanoma and renal cell cancer
M. J. Koretz, D. H. Lawson, R. M. York, S. D. Graham, D. R. Murray, T. M. Gillespie, D. Levitt and K. M. Sell
Department of Surgery, Emory University School of Medicine, Atlanta, Ga.
The purpose of this study was to evaluate the efficacy and safety of a
continuous-infusion interleukin 2 (IL-2) regimen for patients with
metastatic melanoma and renal cell cancer. To investigate the contribution
of adoptively transferred lymphokine-activated killer cells, patients were
randomized to receive either IL-2 alone or IL-2 plus lymphokine-activated
killer cells. Twenty-three patients with renal cell carcinoma and 20 with
melanoma were entered into the protocol. There were no objective responses
noted in the 38 assessable patients (20 with renal cell carcinoma, 18 with
melanoma). Most patients demonstrated progressive disease following one
31-day cycle of weekly continuous-infusion IL-2. Grade I and II toxic
reactions, including fever, rash, anorexia, and weight gain, were common
and treated symptomatically. Significant in vivo stimulation of
lymphokine-activated killer and natural killer cell activity was noted in
most patients. This continuous-infusion IL-2 regimen with or without
lymphokine-activated killer cells was ineffective in the treatment of
melanoma and renal cell carcinoma.
