PHASE-II STUDY OF PACLITAXEL IN PATIENTS WITH RECURRENT MALIGNANT GLIOMA

Purpose: To assess the efficacy and toxicity of paclitaxel administere d as a 3-hour infusion to patients with recurrent malignant glioma. Pa tients and Methods: Adult patients with recurrent malignant radiation therapy, who held received no more than one prior chemotherapy regimen and who had a Karnofsky performance status (KPS) greater than or equa l to 60, were treated with a 3-hour infusion of paclitaxel every 3 wee ks, The initial dose was 210 mg/m(2); dose escalation to 240 mg/m(2) w ets allowed. Tumor response was assessed at 6-week intervals using rad iographic and clinical criteria. Treatment was continued until documen ted tumor progression or a total of 12 paclitaxel infusions. Results: Of 41 eligible patients, all were assessable for treatment toxicity an d 40 (98%) were assessable for response. The response rate (disease st abilization or better) was 35%. Twenty-nine patients (71%) underwent d ose escalation to 240 mg/m(2) without the use of growth factors. Toxic ities included alopecia (98%), nausea (22%), arthralgias (32%), CNS to xicity (24%), peripheral neuropathy (15%), cardiac toxicity (7%), and myelosuppression (10% grade 3 or 4 hematologic toxicity), No patient d eveloped febrile neutropenia, There wets one allergic reaction (2%). C onclusion: Paclitaxel is well tolerated at this dose schedule inpatien ts with recurrent malignant glioma, and affords a modest response rate . Because minimal myelotoxicity was encountered in our patients, a dos e-escalating phase I/II study of paclitaxel is planned to determine th e maximal-tolerated dose (MTD). (C) 1996 by American Society of Clinic al Oncology.