Journal article

An open-label, two-arm, phase I trial of recombinant human interleukin-21 in patients with metastatic melanoma

Ian D Davis, Birte K Skrumsager, Jonathan Cebon, Theo Nicholaou, John W Barlow, Niels Peter Hundahl Moller, Kresten Skak, Dorthe Lundsgaard, Klaus Stensgaard Frederiksen, Peter Thygesen, Grant A McArthur

CLINICAL CANCER RESEARCH | AMER ASSOC CANCER RESEARCH | Published : 2007

Abstract

PURPOSE: Human interleukin-21 (IL-21) is a pleiotropic class I cytokine that activates CD8(+) T cells and natural killer cells. We report a phase 1 study of recombinant human IL-21 in patients with surgically incurable metastatic melanoma. The primary objective was to investigate safety and tolerability by determining dose-limiting toxicity (DLT). The secondary objectives were to identify a dose response for various biomarkers in the peripheral blood, estimate the minimum biologically effective dose, determine the pharmacokinetics of IL-21, determine if anti-IL-21 antibodies were induced during therapy, and measure effects on tumor size according to Response Evaluation Criteria in Solid Tumo..

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