PMID- 17317837 OWN - NLM STAT- MEDLINE DCOM- 20070718 LR - 20220409 IS - 1078-0432 (Print) IS - 1078-0432 (Linking) VI - 13 IP - 4 DP - 2007 Feb 15 TI - Phase II trial of bevacizumab and irinotecan in recurrent malignant glioma. PG - 1253-9 AB - 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/m(2), whereas patients not taking enzyme-inducing antiepileptic drugs received 125 mg/m(2). 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. FAU - Vredenburgh, James J AU - Vredenburgh JJ AD - The Preston Robert Tisch Brain Tumor Center and Department of Surgery, Duke University Medical Center, Durham, North Carolina 27710, USA. vrede001@mc.duke.edu FAU - Desjardins, Annick AU - Desjardins A FAU - Herndon, James E 2nd AU - Herndon JE 2nd FAU - Dowell, Jeannette M AU - Dowell JM FAU - Reardon, David A AU - Reardon DA FAU - Quinn, Jennifer A AU - Quinn JA FAU - Rich, Jeremy N AU - Rich JN FAU - Sathornsumetee, Sith AU - Sathornsumetee S FAU - Gururangan, Sridharan AU - Gururangan S FAU - Wagner, Melissa AU - Wagner M FAU - Bigner, Darell D AU - Bigner DD FAU - Friedman, Allan H AU - Friedman AH FAU - Friedman, Henry S AU - Friedman HS LA - eng GR - 4 R37 CA11898/CA/NCI NIH HHS/United States GR - 5 P50 CA108786/CA/NCI NIH HHS/United States GR - 5 P50 NS20023/NS/NINDS NIH HHS/United States PT - Clinical Trial, Phase II PT - Journal Article PT - Research Support, N.I.H., Extramural PT - Research Support, Non-U.S. Gov't PL - United States TA - Clin Cancer Res JT - Clinical cancer research : an official journal of the American Association for Cancer Research JID - 9502500 RN - 0 (Antibodies, Monoclonal) RN - 0 (Antibodies, Monoclonal, Humanized) RN - 2S9ZZM9Q9V (Bevacizumab) RN - 7673326042 (Irinotecan) RN - XT3Z54Z28A (Camptothecin) SB - IM CIN - Curr Neurol Neurosci Rep. 2008 May;8(3):233-4. PMID: 18541118 CIN - Clin Cancer Res. 2015 Oct 1;21(19):4248-50. PMID: 26429979 MH - Adult MH - Aged MH - Antibodies, Monoclonal/administration & dosage/adverse effects MH - Antibodies, Monoclonal, Humanized MH - Antineoplastic Combined Chemotherapy Protocols/adverse effects/*therapeutic use MH - Bevacizumab MH - Brain Neoplasms/*drug therapy MH - Camptothecin/administration & dosage/adverse effects/analogs & derivatives MH - Female MH - Glioma/*drug therapy MH - Humans MH - Irinotecan MH - Male MH - Middle Aged MH - Neoplasm Recurrence, Local/*drug therapy MH - Prospective Studies EDAT- 2007/02/24 09:00 MHDA- 2007/07/19 09:00 CRDT- 2007/02/24 09:00 PHST- 2007/02/24 09:00 [pubmed] PHST- 2007/07/19 09:00 [medline] PHST- 2007/02/24 09:00 [entrez] AID - 13/4/1253 [pii] AID - 10.1158/1078-0432.CCR-06-2309 [doi] PST - ppublish SO - Clin Cancer Res. 2007 Feb 15;13(4):1253-9. doi: 10.1158/1078-0432.CCR-06-2309.