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

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

Research output: Contribution to journalArticlepeer-review


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/m2/d×5 for chemotherapy naive patients. In patients heavily pretreated with chemotherapy the starting dose was of 150 mg/m2/d×5. 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.

Original languageEnglish
Pages (from-to)89-94
Number of pages6
JournalJournal of Neuro-Oncology
Issue number1
Publication statusPublished - Mar 2006


  • Brain stem tumor
  • Children
  • High-grade glioma
  • Temozolomide
  • Toxicity

ASJC Scopus subject areas

  • Clinical Neurology
  • Cancer Research
  • Oncology
  • Neuroscience(all)


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