Treatment of recurrent malignant glioma with BCNU-fluosol and oxygen inhalation. A phase I-II study.

摘要: Objectives: To evaluate the toxicity and response rate following BCNU with oxygen inhalation escalatingdosages of fluosol administered to patients radiographic progression malignant glioma after definitivesurgery radiotherapy. Method: This single arm, phase I-II multicenter trial, enrolled 99 withmalignant gliomas recurrent definitive surgery All received a fixed dose(200 mg/m2) along 100% fluosol, perfluorochemical. Fluosol doses were escalat-edbetween (150, 275, 400 600 ml/m2). Treatment was repeated every 6 weeks for maximum 6cycles. Patients assessed at time infusion sequentially thereafter. Response wasevaluated clinically radiologically least weeks. Results: well tolerated. Dosereductions required once in 18 patients, treatment delays necessary 33patients. Grade 3-4 leukopenia occurred (12 events), grade thrombocytopenia 10 patients(25 events) liver enzymes elevations (31 events). Higher dosages did notproduce increases or responses. stabilization seen 57% (38% stabiliza-tions)of who entered trial progressive disease. The median 45weeks, survival 66 had stabilization. For withglioblastoma response/stabilization 45% mean duration 24 weeks, withanaplastic astrocytoma 68% 50 Conclusion:This regimen is Our results suggest may enhance effectiveness BCNUfor gliomas. Future studies will be performed using dose of400 ml/m2.