Forty 3 patients have been ineligible. Twelve of these individuals were excluded based selleck on clinical evidence for raised intracra nial stress, 12 had bilateral tumors not amenable to resection, eleven dem onstrated multifocal lesions on imaging, 6 had previously undergone biopsy of the lower grade glioma, five didn’t meet a minimum KPS score of 50, 3 had a prior systemic malignancy, three had infratentorial lesions, four had lesions not amenable to better than 75% resection, and 1 patient was medically unfit for craniotomy. Thirty patients had been excluded based mostly on 1 exclusion criterion alone, eleven based mostly on two criteria, and two primarily based on three on the exclusion criteria. 3 with the eligible patients would happen to be excluded following their surgical method based on a last pathologic diagnosis inconsistent with malignant glioma. 6 added individuals during the study period had nonenhancing mass lesions steady with reduced grade glioma but last pathologic diagnosis con firmed malignant glioma.
Based mostly on this series of individuals, around 39 sufferers annually meet eligibility criteria for randomization and 5% of these will be excluded post procedure to get a diagnosis besides malignant glioma. We predict that total enrollment to get a trial evaluating biopsy versus resection of malignant glioma will must be 344. Assuming 50% enrollment of probably IPI-145 PI3K inhibitors eligible trial candidates, we predict annual enrollment of 19 or twenty individuals at our institu tion. A multicenter trial with ten equivalent institutions could attain accrual in lower than two many years. We system to proceed which has a pilot trial at two institutions. TA 27. PHASE II Study OF ANTIANGIOGENIC CHEMOTHERAPY FOR RECURRENT MALIGNANT GLIOMAS S. Kesari,1 D. Schiff,two L. Doherty,one D. C. Gigas,one T. T. Batchelor,3 A. Muzikansky,3 A. ONeill,3 J. Drappatz,one A. Chen Plotkin,one N.
Ramakrishna,one S. Weiss,one B.
Levy,1 J. Bradshaw,1 P. M. Black,one J. Folkman,four M. Kieran,one,four and P. Y. Wen1, 1Dana Farber/Brigham and Womens Cancer Center, Boston, MA, USA, 2University of Virginia, Charlottesville, VA, USA, 3Massachusetts General Hospital, MA, USA, four Childrens Hospital, Boston, MA, USA Preclinical evidence suggests that continuous minimal dose daily chemotherapy may inhibit tumor endothelial cell proliferation and prevent tumor growth. We conducted a phase II examine of continuous very low dose etoposide, alternating with cyclophospha mide, in combination with thalidomide and celecoxib in adult individuals with recurrent malignant gliomas. Individuals received VP 16 alternating with CP. Thalidomide was started at 200 mg daily and increased by 100 mg weekly. Celecoxib was started at 200 mg twice daily. MRI scans have been performed every six weeks. Individuals had been treated until tumor pro gression or unacceptable toxicity.