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Clinical Trial
. 2006 Mar;77(1):89-94.
doi: 10.1007/s11060-005-9011-2.

Phase II trial of temozolomide in children with recurrent high-grade glioma

A Ruggiero  1 , G Cefalo, M L Garré, M Massimino, C Colosimo, G Attinà, I Lazzareschi, P Maurizi, V Ridola, G Mazzarella, M Caldarelli, C Di Rocco, E Madon, M E Abate, A Clerico, A Sandri, R Riccardi
Affiliations
Clinical Trial

Phase II trial of temozolomide in children with recurrent high-grade glioma

A Ruggiero et al. J Neurooncol. 2006 Mar.

Abstract

Purpose: The objective of the study was to evaluate the efficacy and toxicity of Temozolomide (TMZ) administered for 5 consecutive days in three daily dosing in children with recurrent or refractory high-grade glioma.

Patients and methods: Twenty-four patients with a median age of 10.5 years were enrolled onto this open-label, multicenter, phase II study. The patients were previously treated with surgical resection (17 of 24), radiotherapy (19 of 24) and chemotherapy (18 of 24). Therapy was administered orally three times a day for 5 consecutive days at the dose of 200 mg/m(2)/dx5 for chemotherapy naive patients. In patients heavily pretreated with chemotherapy the starting dose was of 150 mg/m(2)/dx5.

Results: A total of 95 cycles were administered. The median progression free-survival (PFS) was 3 months for the entire group while disease stabilization was obtained in 7 patients (29.1%), all with supratentorial tumors. No CR or PR was observed. TMZ treatment showed a limited toxicity. Thrombocytopenia was the most common hematological adverse effect. Our data suggest a marginal activity of TMZ in children with recurrent high-grade glioma.

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