Abstract | PURPOSE: EXPERIMENTAL DESIGN: Phase I component used an interpatient dose escalation scheme. End points of the phase II component were 6-month progression-free survival and response. RESULTS: Fifty patients enrolled in the phase I component (27 EIAED and 23 non-EIAED). The maximum tolerated dose for non-EIAED patients was 800 mg/d. Dose-limiting toxicities were neutropenia, rash, and elevated alanine aminotransferase. EIAED patients received up to 1,200 mg/d imatinib without developing dose-limiting toxicity. Plasma exposure of imatinib was reduced by approximately 68% in EIAED patients compared with non-EIAED patients. Fifty-five non-EIAED patients (34 glioblastoma multiforme and 21 anaplastic glioma) enrolled in the phase II component. Patients initially received 800 mg/d imatinib; 15 anaplastic glioma patients received 600 mg/d after hemorrhages were observed. There were 2 partial response and 6 stable disease among glioblastoma multiforme patients and 0 partial response and 5 stable disease among anaplastic glioma patients. Six-month progression-free survival was 3% for glioblastoma multiforme and 10% for anaplastic glioma patients. Five phase II patients developed intratumoral hemorrhages. CONCLUSIONS:
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Authors | Patrick Y Wen, W K Alfred Yung, Kathleen R Lamborn, Patricia L Dahia, Yanfeng Wang, Bin Peng, Lauren E Abrey, Jeffrey Raizer, Timothy F Cloughesy, Karen Fink, Mark Gilbert, Susan Chang, Larry Junck, David Schiff, Frank Lieberman, Howard A Fine, Minesh Mehta, H Ian Robins, Lisa M DeAngelis, Morris D Groves, Vinay K Puduvalli, Victor Levin, Charles Conrad, Elizabeth A Maher, Kenneth Aldape, Michael Hayes, Laurie Letvak, Merrill J Egorin, Renaud Capdeville, Richard Kaplan, Anthony J Murgo, Charles Stiles, Michael D Prados |
Journal | Clinical cancer research : an official journal of the American Association for Cancer Research
(Clin Cancer Res)
Vol. 12
Issue 16
Pg. 4899-907
(Aug 15 2006)
ISSN: 1078-0432 [Print] United States |
PMID | 16914578
(Publication Type: Clinical Trial, Phase I, Clinical Trial, Phase II, Journal Article, Multicenter Study, Research Support, N.I.H., Extramural, Research Support, Non-U.S. Gov't)
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Chemical References |
- Anticonvulsants
- Antineoplastic Agents
- Benzamides
- Piperazines
- Pyrimidines
- Imatinib Mesylate
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Topics |
- Adolescent
- Adult
- Aged
- Anticonvulsants
(therapeutic use)
- Antineoplastic Agents
(adverse effects, pharmacokinetics, therapeutic use)
- Benzamides
- Brain Neoplasms
(drug therapy, genetics, metabolism)
- Drug Interactions
- Female
- Genotype
- Glioma
(drug therapy, genetics, metabolism)
- Humans
- Imatinib Mesylate
- Male
- Middle Aged
- Piperazines
(adverse effects, pharmacokinetics, therapeutic use)
- Pyrimidines
(adverse effects, pharmacokinetics, therapeutic use)
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