Phase II trial of temozolomide in children with recurrent high-grade glioma
作者： Antonio Ruggiero , Graziella Cefalo , ML Garre , Maura Massimino , Cesare Colosimo
DOI: 10.1007/S11060-005-9011-2
关键词: Toxicity 、 Medicine 、 Chemotherapy 、 Gastroenterology 、 Glioma 、 Surgery 、 Internal medicine 、 Temozolomide 、 Phases of clinical research 、 Refractory 、 Radiation therapy 、 Brain stem tumor
摘要: Summary Purpose: The objective of the study was to evaluate efficacy and toxicity Temozolomide (TMZ) administered for 5 consecutive days in three daily dosing children with recurrent or refractory high-grade glioma. Patients methods: Twenty-four patients a median age 10.5 years were enrolled onto this open-label, multicenter, phase II study. previously treated surgical resection (17 24), radiotherapy (19 24) chemotherapy (18 24). Therapy orally times day at dose 200 mg/m 2 /d5 naive patients. In heavily pretreated starting 150 /d5. Results: A total 95 cycles administered. progression free-survival (PFS) 3 months entire group while disease stabilization obtained 7 (29.1%), all supratentorial tumors. No CR PR observed. TMZ treatment showed limited toxicity. Thrombocytopenia most common hematological adverse effect.Our data suggest marginal activity
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