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J Neurooncol. 2006 Mar;77(1):89-94.

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

Author information

1
Dipartimento di Scienze Pediatriche, Medico-Chirurgiche e di Neuroscienze dello Sviluppo, Università Cattolica, Rome, Italy.

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.

PMID:
16292488
DOI:
10.1007/s11060-005-9011-2
[Indexed for MEDLINE]

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