A Phase II Trial of Sunitinib in the Treatment of Recurrent Malignant Gliomas

Division Of Basic Sciences - Nci

Investigators

Abstract

Objectives: 1. To evaluate the anti-glioma activity of sunitinib in patients with recurrent malignant gliomas who are either naive or resistant to prior bevacizumab therapy. Eligibility: Patients with recurrent malignant glioma are eligible for this study. Design: 1. This is a phase II study with a target enrollment of 64 patients who have not progressed on prior treatment with anti-VEGF therapy, and 64 patients who have progressed on prior bevacizumab therapy. 2. Sunitinib will be self-administered orally at 37.5 mg daily, with dose adjustments allowed for toxicity and concomitant drug interactions. 3. The primary endpoint is six-month progression free survival for both arms of the study.