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

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


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.

Publication types

  • Clinical Trial, Phase II
  • Multicenter Study

MeSH terms

  • Adolescent
  • Antineoplastic Agents, Alkylating / adverse effects
  • Antineoplastic Agents, Alkylating / therapeutic use*
  • Bone Marrow / drug effects
  • Brain Neoplasms / drug therapy*
  • Child
  • Child, Preschool
  • Dacarbazine / adverse effects
  • Dacarbazine / analogs & derivatives*
  • Dacarbazine / therapeutic use
  • Disease-Free Survival
  • Drug Administration Schedule
  • Female
  • Glioma / drug therapy*
  • Humans
  • Male
  • Neoplasm Recurrence, Local / drug therapy*
  • Neutropenia / chemically induced
  • Temozolomide
  • Thrombocytopenia / chemically induced
  • Treatment Outcome


  • Antineoplastic Agents, Alkylating
  • Dacarbazine
  • Temozolomide