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Cilengitide for glioblastoma
Integrin inhibitor combined with chemoradiation for glioblastoma
In the Unites States a safety run-in and randomized phase 2 study of cilengitide combined with chemoradiation for newly diagnosed glioblastoma was contucted. Cilengitide is a selective integrin inhibitor that is well tolerated and has demonstrated biologic activity in patients with recurrent malignant glioma. The primary objectives of this trial were to determine the safety and efficacy of cilengitide and to select a dose for comparative clinical testing.
In total, 112 patients were accrued. Eighteen patients received standard radiation and temozolomide with cilengitide in a safety run-in phase followed by a randomized phase 2 trial with 94 patients assigned to either a 500 mg dose group or 2000 mg dose group.
Cilengitide at all doses studied was well tolerated with radiation and temozolomide. The median survival was 19.7 months for all patients, 17.4 months for the patients in the 500 mg dose group, 20.8 months for patients in the 2000 mg dose group, 30 months for patients who had methylated O6-methylguanine-DNA methyltransferase (MGMT) status, and 17.4 months for patients who had unmethylated MGMT status.
The authors concluded that, from an efficacy and safety standpoint, future trials of this agent in this population should use the 2000 mg dose.
© 16.05.2012 mth, Deutsche Hirntumorhilfe e.V. | www.hirntumorhilfe.org
Source: Cancer 2012 Apr 19. doi: 10.1002/cncr.27585
