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 journalArticle

38 Citations (Scopus)

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/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
Volume77
Issue number1
DOIs
Publication statusPublished - Mar 2006

Fingerprint

temozolomide
Glioma
Drug Therapy
Supratentorial Neoplasms
Thrombocytopenia
Disease-Free Survival
Radiotherapy

Keywords

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

ASJC Scopus subject areas

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

Cite this

Phase II trial of temozolomide in children with recurrent high-grade glioma. / Ruggiero, A.; Cefalo, G.; Garré, M. L.; Massimino, M.; Colosimo, C.; Attinàa, G.; Lazzareschi, I.; Maurizi, P.; Ridola, V.; Mazzarella, G.; Caldarelli, M.; Di Rocco, C.; Madon, E.; Abate, M. E.; Clerico, A.; Sandri, A.; Riccardi, R.

In: Journal of Neuro-Oncology, Vol. 77, No. 1, 03.2006, p. 89-94.

Research output: Contribution to journalArticle

Ruggiero, A, Cefalo, G, Garré, ML, Massimino, M, Colosimo, C, Attinàa, G, Lazzareschi, I, Maurizi, P, Ridola, V, Mazzarella, G, Caldarelli, M, Di Rocco, C, Madon, E, Abate, ME, Clerico, A, Sandri, A & Riccardi, R 2006, 'Phase II trial of temozolomide in children with recurrent high-grade glioma', Journal of Neuro-Oncology, vol. 77, no. 1, pp. 89-94. https://doi.org/10.1007/s11060-005-9011-2
Ruggiero, A. ; Cefalo, G. ; Garré, M. L. ; Massimino, M. ; Colosimo, C. ; Attinàa, G. ; Lazzareschi, I. ; Maurizi, P. ; Ridola, V. ; Mazzarella, G. ; Caldarelli, M. ; Di Rocco, C. ; Madon, E. ; Abate, M. E. ; Clerico, A. ; Sandri, A. ; Riccardi, R. / Phase II trial of temozolomide in children with recurrent high-grade glioma. In: Journal of Neuro-Oncology. 2006 ; Vol. 77, No. 1. pp. 89-94.
@article{98acedd83efc438490be04130b0788fb,
title = "Phase II trial of temozolomide in children with recurrent high-grade glioma",
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/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.",
keywords = "Brain stem tumor, Children, High-grade glioma, Temozolomide, Toxicity",
author = "A. Ruggiero and G. Cefalo and Garr{\'e}, {M. L.} and M. Massimino and C. Colosimo and G. Attin{\`a}a and I. Lazzareschi and P. Maurizi and V. Ridola and G. Mazzarella and M. Caldarelli and {Di Rocco}, C. and E. Madon and Abate, {M. E.} and A. Clerico and A. Sandri and R. Riccardi",
year = "2006",
month = "3",
doi = "10.1007/s11060-005-9011-2",
language = "English",
volume = "77",
pages = "89--94",
journal = "Journal of Neuro-Oncology",
issn = "0167-594X",
publisher = "Springer New York LLC",
number = "1",

}

TY - JOUR

T1 - Phase II trial of temozolomide in children with recurrent high-grade glioma

AU - Ruggiero, A.

AU - Cefalo, G.

AU - Garré, M. L.

AU - Massimino, M.

AU - Colosimo, C.

AU - Attinàa, G.

AU - Lazzareschi, I.

AU - Maurizi, P.

AU - Ridola, V.

AU - Mazzarella, G.

AU - Caldarelli, M.

AU - Di Rocco, C.

AU - Madon, E.

AU - Abate, M. E.

AU - Clerico, A.

AU - Sandri, A.

AU - Riccardi, R.

PY - 2006/3

Y1 - 2006/3

N2 - 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.

AB - 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.

KW - Brain stem tumor

KW - Children

KW - High-grade glioma

KW - Temozolomide

KW - Toxicity

UR - http://www.scopus.com/inward/record.url?scp=33745021711&partnerID=8YFLogxK

UR - http://www.scopus.com/inward/citedby.url?scp=33745021711&partnerID=8YFLogxK

U2 - 10.1007/s11060-005-9011-2

DO - 10.1007/s11060-005-9011-2

M3 - Article

VL - 77

SP - 89

EP - 94

JO - Journal of Neuro-Oncology

JF - Journal of Neuro-Oncology

SN - 0167-594X

IS - 1

ER -