Long-term effects of cilengitide, a novel integrin inhibitor, in recurrent glioblastoma: A randomized phase IIa study.

• DOI: 10.1200/jco.2010.28.15_suppl.2010
• Publication Date: 2017-02-24T02:41:10Z
• Authors: K. Fink; T. Mikkelsen; L. B. Nabors; P. Ravin; S. R. Plotkin; D. Schiff; C. Hicking; M. Picard; D. A. Reardon
• Keywords: 03 medical and health sciences; 0302 clinical medicine; 3. Good health

2010 Background: Prognosis of patients with recurrent glioblastoma multiforme (GBM) is poor. Cilengitide an investigational selective αvβ3/5 integrin inhibitor multiple anti-tumor effects. In a randomized phase IIa trial cilengitide in GBM, median overall survival (OS) was 9.9 months (2,000 mg arm) vs. 6.5 (500 [Reardon et al, JCO 2008]. Long-term follow up data are reported here. Methods: A randomized, multicenter, open-label examined effects 2 monotherapy regimens: 500 (n = 41) and 2,000 40). Prior to inclusion, had surgery or biopsy, chemoradiation (temozolomide) measurable contrast enhanced tumor size (1 cm2). infused over 1 hour twice-weekly during 4-week cycle until disease progression unacceptable adverse events. Eligible subjects were ≥ 18 years histologically-confirmed stable corticosteroid dose, satisfactory hematologic biochemical results, Karnofsky performance score 70. Results: Mean treatment duration 139 days (range 11–1390). Median follow-up 53.3 48.3 for mg, respectively. OS rates consistently greater (37.3, 22.5, 15.0, 10.0 10.0% at 12, 24, 36, 48 54 months, respectively) vs (22.0, 12.2, 4.9, 2.4 0% respectively): hazard ratio 0.635 95% confidence interval 0.402–1.003. Fifteen received > 6 year. Treatment-related AEs (AEs) tended occur within receiving the first dose most common (> subject) fatigue 3), while grade 3/4 serious AE convulsion 2). No study drug-related occurred from only that time. Conclusions: well tolerated feasible twice weekly regimen 4 follow-up. versus lower-dose group this II study. Author Disclosure Employment Leadership Position Consultant Advisory Role Stock Ownership Honoraria Research Funding Expert Testimony Other Remuneration Merck KGaA EMD Serono,