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Annals of Oncology 14:1732-1734, 2003
© 2003 European Society for Medical Oncology

Original Paper

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

M. J. van den Bent1,+, W. Grisold2, D. Frappaz3, R. Stupp4, J. P. Desir5, T. Lesimple6, C. Dittrich2, M. J. A. de Jonge1, A. Brandes7, M. Frenay8, A. F. Carpentier9, P. Chollet10, J. Oliveira11, B. Baron12, D. Lacombe12, M. Schuessler13 and P. Fumoleau14

1 Daniel den Hoed Cancer Center/Erasmus University Medical Center, Rotterdam, The Netherlands; 2 LBI-ACR Vienna and Kaiser Franz Josef Spital, Vienna, Austria; 3 Centre Léon Bérard, Lyon, France; 4 Centre Hospitalier Universitaire Vaudois, Lausanne, Switzerland; 5 Centre Georges-François-Leclerc, Dijon; 6 Centre Eugène Marquis, Rennes, France; 7 Medical Oncology Department University Hospital-Padova, Padova, Italy; 8 Centre Lacassagne, Nice; 9 CHU Pitié-Salpétrière, Paris; 10 Centre Jean Perrin, Clermont-Ferrand, France; 11 IPO Francisco Gentil-Centro de Lisboa, Portugal; 12 EORTC Data Center, Brussels, Belgium; 13 Baxter Oncology GmbH, Frankfurt/Main, Germany; 14 Centre René Gauducheau, Nantes-St Herblain, France

Received 23 April 2003; revised 17 June 2003; accepted 12 August 2003

Background:

Glufosfamide is a new alkylating agent in which the active metabolite of isophosphoramide mustard is covalently linked to ß-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.

Key words: chemotherapy, glioblastoma multiforme, glufosfamide, recurrent


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