An Open-Label, Two-Arm, Phase I Trial of Recombinant Human Interleukin-21 in Patients with Metastatic Melanoma
Open Access
- 15 June 2007
- journal article
- Published by American Association for Cancer Research (AACR) in Clinical Cancer Research
- Vol. 13 (12) , 3630-3636
- https://doi.org/10.1158/1078-0432.ccr-07-0410
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 Tumors.Keywords
This publication has 27 references indexed in Scilit:
- Cancer Statistics, 2007CA: A Cancer Journal for Clinicians, 2007
- Sa.54. Interleukin-21: Intravenous Administration of Interleukin-21 Leads to Immune Activation in Humans-Preliminary Results from a Phase 1 TrialClinical Immunology, 2006
- 265 POSTER Recombinant human Interleukin-21 (rIL-21), a new cytokine for immunotherapy: results of two phase 1 studies in patients with metastatic melanoma (MM) or renal cell carcinoma (RCC)European Journal of Cancer Supplements, 2006
- Synergy of IL-21 and IL-15 in regulating CD8+ T cell expansion and functionThe Journal of Experimental Medicine, 2005
- Update on the Role of Interleukin 2 and Other Cytokines in the Treatment of Patients with Stage IV Renal CarcinomaClinical Cancer Research, 2004
- Transduction of the IL-21 and IL-23 genes in human pancreatic carcinoma cells produces natural killer cell-dependent and -independent antitumor effectsCancer Gene Therapy, 2003
- Expression of the interleukin-21 gene in murine colon carcinoma cells generates systemic immunity in the inoculated hostsCancer Gene Therapy, 2003
- Interleukin 21 prevents antigen-induced IgE production by inhibiting germ line Cε transcription of IL-4–stimulated B cellsBlood, 2002
- New Guidelines to Evaluate the Response to Treatment in Solid TumorsJNCI Journal of the National Cancer Institute, 2000
- Metabolism of Tac (IL2Ralpha): physiology of cell surface shedding and renal catabolism, and suppression of catabolism by antibody binding.The Journal of Experimental Medicine, 1996