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

Détails

ID Serval
serval:BIB_94C9A814A7B7
Type
Article: article d'un périodique ou d'un magazine.
Collection
Publications
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
Périodique
Annals of Oncology
Auteur(s)
van den Bent  M. J., Grisold  W., Frappaz  D., Stupp  R., Desir  J. P., Lesimple  T., Dittrich  C., de Jonge  M. J., Brandes  A., Frenay  M., Carpentier  A. F., Chollet  P., Oliveira  J., Baron  B., Lacombe  D., Schuessler  M., Fumoleau  P.
ISSN
0923-7534 (Print)
Statut éditorial
Publié
Date de publication
12/2003
Volume
14
Numéro
12
Pages
1732-4
Notes
Clinical Trial
Clinical Trial, Phase II
Journal Article
Multicenter Study
Research Support, Non-U.S. Gov't --- Old month value: Dec
Résumé
BACKGROUND: Glufosfamide is a new alkylating agent in which the active metabolite of isophosphoramide mustard is covalently linked to beta-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/m(2) 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.
Mots-clé
Adult Aged Antineoplastic Agents/*adverse effects/pharmacokinetics/*therapeutic use Brain Neoplasms/*drug therapy/pathology Disease-Free Survival Female Glioblastoma/*drug therapy/pathology Humans Infusions, Intravenous Male Middle Aged Phosphoramide Mustards/*administration & dosage/adverse effects/pharmacokinetics/*therapeutic use Treatment Outcome
Pubmed
Web of science
Open Access
Oui
Création de la notice
28/01/2008 9:39
Dernière modification de la notice
08/05/2019 22:14
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