Cilengitide in patients with newly diagnosed glioblastoma multiforme and unmethylated MGMT gene promoter: Protocol of a multicenter, randomized, open-label, controlled phase II study.

TPS151 Background: Expected median survival is poor for patients with glioblastoma multiforme (GBM). Cilengitide, an investigational selective αvβ3/5 integrin inhibitor, has demonstrated antitumor activity against GBM in previous phase II studies. CORE (cilengitide in combination with temozolomide [TMZ] and radiotherapy [RTX]) will assess the efficacy and safety of 2 regimens of cilengitide in GBM patients with an unmethylated MGMT promoter. The study is a companion trial to CENTRIC, which includes patients with newly diagnosed GBM with methylated MGMT promoter. Methods: CORE is a phase II, randomized, multicenter, open-label, controlled, trial investigating 2 regimens of i.v. cilengitide in combination with standard therapy [RTX/TMZ then TMZ; Stupp et al NEJM 2005] vs standard therapy alone (2:2:1 ratio). The 2 cilengitide regimens compare 2,000 mg twice weekly vs. 2,000 mg 5 times weekly on each day of RTX during 6 weeks of RTX/TMZ, followed by cilengitide 2,000 mg twice-weekly combined with TMZ, follow...