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European Organization for Research and Treatment of Cancer (EORTC) open label phase II study on glufosfamide administered as a 60-minute infusion every 3 weeks in recurrent glioblastoma multiforme

van den Bent, M. J. ; Grisold, W. ; Frappaz, D. ; Stupp, R. ; Desir, J. P. ; Lesimple, T. ; Dittrich, C. ; de Jonge, M. J. A. ; Brandes, A. ; Frenay, M. ; Carpentier, A. F. ; Chollet, P. ; Oliveira, J. ; Baron, B. ; Lacombe, D. ; Schuessler, M. ; Fumoleau, P.

In: Annals of Oncology, 2003, vol. 14, no. 12, p. 1732-1734

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    Titre
    • European Organization for Research and Treatment of Cancer (EORTC) open label phase II study on glufosfamide administered as a 60-minute infusion every 3 weeks in recurrent glioblastoma multiforme
    Auteur
    • van den Bent, M. J.. Daniel den Hoed Cancer Center/Erasmus University Medical Center, Rotterdam, The Netherlands
    • Grisold, W.. LBI-ACR Vienna and Kaiser Franz Josef Spital, Vienna, Austria
    • Frappaz, D.. Centre Léon Bérard, Lyon, France
    • Stupp, R.. Centre Hospitalier Universitaire Vaudois, Lausanne, Switzerland
    • Desir, J. P.. Centre Georges-François-Leclerc, Dijon
    • Lesimple, T.. Centre Eugène Marquis, Rennes, France
    • Dittrich, C.. LBI-ACR Vienna and Kaiser Franz Josef Spital, Vienna, Austria
    • de Jonge, M. J. A.. Daniel den Hoed Cancer Center/Erasmus University Medical Center, Rotterdam, The Netherlands
    • Brandes, A.. Medical Oncology Department University Hospital-Padova, Padova, Italy
    • Frenay, M.. Centre Lacassagne, Nice
    • Carpentier, A. F.. CHU Pitié-Salpétrière, Paris
    • Chollet, P.. Centre Jean Perrin, Clermont-Ferrand, France
    • Oliveira, J.. IPO Francisco Gentil-Centro de Lisboa, Portugal
    • Baron, B.. EORTC Data Center, Brussels, Belgium
    • Lacombe, D.. EORTC Data Center, Brussels, Belgium
    • Schuessler, M.. Baxter Oncology GmbH, Frankfurt/Main, Germany
    • Fumoleau, P.. Centre René Gauducheau, Nantes-St Herblain, France
    Type de document
    • Postprint
    Langue
    • Anglais
    Publié dans
    • Annals of Oncology, 2003, vol. 14, no. 12, p. 1732-1734. Oxford University Press
    Autre version électronique
    Identifiant OAI-PMH
    • oai:doc.rero.ch:301353
    Summary
    Background: Glufosfamide is a new alkylating agent in which the active metabolite of isophosphoramide mustard is covalently linked to β-d-glucose to target the glucose transporter system and increase intracellular uptake in tumor cells. We investigated this drug in a multicenter prospective phase II trial in recurrent glioblastoma multiforme (GBM). Patients and methods: Eligible patients had recurrent GBM following surgery, radiotherapy and no more than one prior line of chemotherapy. Patients were treated with glufosfamide 5000 mg/m2 administered as a 1-h intravenous infusion. Treatment success was defined as patients with either an objective response according to Macdonald's criteria or 6 months progression-free survival. Toxicity was assessed with the Common Toxicity Criteria (CTC) version 2.0. Results: Thirty-one eligible patients were included. Toxicity was modest, the main clinically relevant toxicities being leukopenia (CTC grade >3 in five patients) and hepatotoxicity (in three patients). No responses were observed; one patient (3%; 95% confidence interval 0 to 17%) was free from progression at 6 months. Pharmacokinetic analysis showed a 15% decrease in area under the curve and glufosfamide clearance in patients treated with enzyme-inducing antiepileptic drugs, but no effect of these drugs on maximum concentration and plasma half-life. Conclusion: Glufosfamide did not show significant clinical antitumor activity in patients with recurrent GBM