title: Phase II trial of temozolomide in children with recurrent high-grade glioma.
abstract: OBJECTIVE
  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.
  
  
  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.
authors.affiliation: Dipartimento di Scienze Pediatriche, Medico-Chirurgiche e di Neuroscienze dello Sviluppo, Università Cattolica, Rome, Italy.
authors.forename: A
authors.initials: A
authors.lastname: Ruggiero
authors.forename: G
authors.initials: G
authors.lastname: Cefalo
authors.forename: M L
authors.initials: ML
authors.lastname: Garré
authors.forename: M
authors.initials: M
authors.lastname: Massimino
authors.forename: C
authors.initials: C
authors.lastname: Colosimo
authors.forename: G
authors.initials: G
authors.lastname: Attinà
authors.forename: I
authors.initials: I
authors.lastname: Lazzareschi
authors.forename: P
authors.initials: P
authors.lastname: Maurizi
authors.forename: V
authors.initials: V
authors.lastname: Ridola
authors.forename: G
authors.initials: G
authors.lastname: Mazzarella
authors.forename: M
authors.initials: M
authors.lastname: Caldarelli
authors.forename: C
authors.initials: C
authors.lastname: Di Rocco
authors.forename: E
authors.initials: E
authors.lastname: Madon
authors.forename: M E
authors.initials: ME
authors.lastname: Abate
authors.forename: A
authors.initials: A
authors.lastname: Clerico
authors.forename: A
authors.initials: A
authors.lastname: Sandri
authors.forename: R
authors.initials: R
authors.lastname: Riccardi
mesh_terms: D000293:Adolescent; D018906:Antineoplastic Agents, Alkylating / Q000009:adverse effects / Q000627:therapeutic use*; D001853:Bone Marrow / Q000187:drug effects; D001932:Brain Neoplasms / Q000188:drug therapy*; D002648:Child; D002675:Child, Preschool; D003606:Dacarbazine / Q000009:adverse effects / Q000031:analogs & derivatives* / Q000627:therapeutic use; D018572:Disease-Free Survival; D004334:Drug Administration Schedule; D005260:Female; D005910:Glioma / Q000188:drug therapy*; D006801:Humans; D008297:Male; D009364:Neoplasm Recurrence, Local / Q000188:drug therapy*; D009503:Neutropenia / Q000139:chemically induced; D000077204:Temozolomide; D013921:Thrombocytopenia / Q000139:chemically induced; D016896:Treatment Outcome
chemical_list: D018906:Antineoplastic Agents, Alkylating; D003606:Dacarbazine; D000077204:Temozolomide