A phase II safety study of bevacizumab in patients with multiple recurrent or progressive malignant gliomas

Abstract

2079 Introduction: Available treatment options for patients with recurrent MG are few. Recent trends have used target specific agents but none has been effective to date. A single agent trial was designed to determine the safety and efficacy of bevacizumab in patients with recurrent MG. Recently, bevacizumab and CPT-11 in combination have shown response rates of approximately 60%. Patients and Methods: All patients (pts) had to sign an IRB informed consent. All pts had to have at least two relapses. Pts had to be > 18 year of age with Karnofsky performance status of > 60. Adequate bone marrow, liver and renal function was required, as well as normal urine protein and creatinine. Patients were required to be on a non-enzyme inducing anti-convulsants. An MRI with perfusion was done at baseline (if patient consented) and then every 6 weeks. Patients continued on trial as long as they did not have tumor progression. Patients received bevacizumab 15 mg/kg every 3 weeks as a 60–90 minute infusion. Results: To date, 16 pts with recurrent MG have been treated. 14 pts had a glioblastoma (GBM) and 2 had an anaplastic oligodendroglioma (AO). Median number of doses given was 3 (range 1–12). No patient had an intracranial hemorrhage and the only significant toxicity was a DVT in a patient with prior DVT. Best responses per McDonald criteria were: PR in 2 pts, SD in 4 pts, PD in 3 pts and non-evaluable in 7 pts: 4 follow up imaging not done, 1 each with stable MRI after 2 doses but WD for non-compliance, clinical decline and patient’s choice. Results: Bevacizumab as a single agent given every 3 weeks at 15 mg/kg is safe. Partial responses and stable disease were seen in about 30 % of patients with follow up imaging but many patients are early in treatment. Our response rates to date are lower then previous reports of patients treated with CPT-11 and bevacizumab; this maybe due to the increased number of prior therapies, a different schedule of bevacizumab or the omission of CPT-11. Updated response rates, time to progression and overall survival will be presented. [Table: see text] No significant financial relationships to disclose.