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Clinical Cancer Research 13, 1253, February 15, 2007. doi: 10.1158/1078-0432.CCR-06-2309
© 2007 American Association for Cancer Research
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Cancer Therapy: Clinical

Phase II Trial of Bevacizumab and Irinotecan in Recurrent Malignant Glioma

James J. Vredenburgh1,2,3, Annick Desjardins1,2,3, James E. Herndon, II4, Jeannette M. Dowell4, David A. Reardon1,2,5, Jennifer A. Quinn1,2,3, Jeremy N. Rich1,2,3,6, Sith Sathornsumetee1,2,3, Sridharan Gururangan1,2,5, Melissa Wagner1,2, Darell D. Bigner1,2,7, Allan H. Friedman1,2 and Henry S. Friedman1,2,3,5

Authors' Affiliations: 1 The Preston Robert Tisch Brain Tumor Center and Departments of 2 Surgery, 3 Medicine, 4 Biostatistics, 5 Pediatrics, 6 Neurobiology, and 7 Pathology, Duke University Medical Center, Durham, North Carolina

Requests for reprints: James J. Vredenburgh, Duke University Medical Center, Box 3624, Durham, NC 27710. Phone: 919-681-3824; Fax: 919-684-6674; E-mail: vrede001{at}mc.duke.edu.

Purpose: Recurrent grade III-IV gliomas have a dismal prognosis with minimal improvements in survival seen following currently available salvage therapy. This study was conducted to determine if the combination of a novel antiangiogenic therapy, bevacizumab, and a cytotoxic agent, irinotecan, is safe and effective for patients with recurrent grade III-IV glioma.

Experimental Design: We conducted a phase II trial of bevacizumab and irinotecan in adults with recurrent grade III-IV glioma. Patients with evidence of intracranial hemorrhage on initial brain magnetic resonance imaging were excluded. Patients were scheduled to receive bevacizumab and irinotecan i.v. every 2 weeks of a 6-week cycle. Bevacizumab was administered at 10 mg/kg. The dose of irinotecan was determined based on antiepileptic use: patients taking enzyme-inducing antiepileptic drugs received 340 mg/m2, whereas patients not taking enzyme-inducing antiepileptic drugs received 125 mg/m2. Toxicity and response were assessed.

Results: Thirty-two patients were assessed (23 with grade IV glioma and 9 with grade III glioma). Radiographic responses were noted in 63% (20 of 32) of patients (14 of 23 grade IV patients and 6 of 9 grade III patients). The median progression-free survival was 23 weeks for all patients (95% confidence interval, 15-30 weeks; 20 weeks for grade IV patients and 30 weeks for grade III patients). The 6-month progression-free survival probability was 38% and the 6-month overall survival probability was 72%. No central nervous system hemorrhages occurred, but three patients developed deep venous thromboses or pulmonary emboli, and one patient had an arterial ischemic stroke.

Conclusions: The combination of bevacizumab and irinotecan is an active regimen for recurrent grade III-IV glioma with acceptable toxicity.




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