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
Details
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State: Public
Version: Final published version
License: Not specified
It was possible to publish this article open access thanks to a Swiss National Licence with the publisher.
State: Public
Version: Final published version
License: Not specified
It was possible to publish this article open access thanks to a Swiss National Licence with the publisher.
Serval ID
serval:BIB_94C9A814A7B7
Type
Article: article from journal or magazin.
Collection
Publications
Institution
Title
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
Journal
Annals of Oncology
ISSN
0923-7534 (Print)
Publication state
Published
Issued date
12/2003
Volume
14
Number
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
Clinical Trial, Phase II
Journal Article
Multicenter Study
Research Support, Non-U.S. Gov't --- Old month value: Dec
Abstract
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.
Keywords
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
Yes
Create date
28/01/2008 9:39
Last modification date
14/02/2022 8:56