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

*Corresponding author for this work

Research output: Contribution to journalArticlepeer-review

36 Scopus citations

Abstract

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.

Original languageEnglish (US)
Pages (from-to)1732-1734
Number of pages3
JournalAnnals of Oncology
Volume14
Issue number12
DOIs
StatePublished - Dec 2003

Keywords

  • Chemotherapy
  • Glioblastoma multiforme
  • Glufosfamide
  • Recurrent

ASJC Scopus subject areas

  • Hematology
  • Oncology

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