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A phase II single-arm study of irinotecan in combination with temozolomide (TEMIRI) in children with newly diagnosed high grade glioma: a joint ITCC and SIOPE-brain tumour study.

Publication ,  Journal Article
Hargrave, D; Geoerger, B; Frappaz, D; Pietsch, T; Gesner, L; Cisar, L; Breazna, A; Dorman, A; Cruz-Martinez, O; Fuster, JL; Rialland, X ...
Published in: J Neurooncol
May 2013

A multicenter, two stage phase II study, investigated irinotecan plus temozolomide in children with newly diagnosed high grade glioma. The primary endpoint was tumor response during a two-cycle treatment window, confirmed by external review committee. Patients received oral temozolomide 100 mg/(m(2) day) (days 1-5) and intravenous irinotecan 10 mg/(m(2) day) (days 1-5 and 8-12) for two 21-day cycles (three cycles for patients exhibiting objective tumor response). Standard treatment was then administered according to local investigator choice. In total 17 patients were enrolled and treated by local investigators. However, central pathology review found three patients did not have a diagnosis of high grade glioma and another four patients did not have evaluable disease according to independent central radiological review. The primary endpoint was based on the first ten evaluable patients as determined by the external review committee. Recruitment was stopped for futility after there were no complete or partial responses during the two-cycle treatment window in the first ten evaluable patients. Five patients had stable disease, and five progressed. Data for secondary endpoints including; time to tumor progression, time to treatment failure, and overall survival is reported. The safety profile of the treatment showed the combination was tolerable with two patients (11.8 %) having grade three nausea, and one (5.9 %) experiencing a grade four neutropenia, leading to permanent discontinuation from adjuvant treatment. Irinotecan plus temozolomide, although well tolerated did not improve outcome over historical controls in this setting.

Duke Scholars

Published In

J Neurooncol

DOI

EISSN

1573-7373

Publication Date

May 2013

Volume

113

Issue

1

Start / End Page

127 / 134

Location

United States

Related Subject Headings

  • Treatment Outcome
  • Temozolomide
  • Oncology & Carcinogenesis
  • Neoplasm Grading
  • Male
  • Irinotecan
  • Humans
  • Glioma
  • Female
  • Dacarbazine
 

Citation

APA
Chicago
ICMJE
MLA
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Hargrave, D., Geoerger, B., Frappaz, D., Pietsch, T., Gesner, L., Cisar, L., … Grill, J. (2013). A phase II single-arm study of irinotecan in combination with temozolomide (TEMIRI) in children with newly diagnosed high grade glioma: a joint ITCC and SIOPE-brain tumour study. J Neurooncol, 113(1), 127–134. https://doi.org/10.1007/s11060-013-1098-2
Hargrave, Darren, Birgit Geoerger, Didier Frappaz, Torsten Pietsch, Lyle Gesner, Laura Cisar, Aurora Breazna, et al. “A phase II single-arm study of irinotecan in combination with temozolomide (TEMIRI) in children with newly diagnosed high grade glioma: a joint ITCC and SIOPE-brain tumour study.J Neurooncol 113, no. 1 (May 2013): 127–34. https://doi.org/10.1007/s11060-013-1098-2.
Hargrave, Darren, et al. “A phase II single-arm study of irinotecan in combination with temozolomide (TEMIRI) in children with newly diagnosed high grade glioma: a joint ITCC and SIOPE-brain tumour study.J Neurooncol, vol. 113, no. 1, May 2013, pp. 127–34. Pubmed, doi:10.1007/s11060-013-1098-2.
Hargrave D, Geoerger B, Frappaz D, Pietsch T, Gesner L, Cisar L, Breazna A, Dorman A, Cruz-Martinez O, Fuster JL, Rialland X, Icher C, Leblond P, Ashley D, Perilongo G, Elliott M, English M, Clausen N, Grill J. A phase II single-arm study of irinotecan in combination with temozolomide (TEMIRI) in children with newly diagnosed high grade glioma: a joint ITCC and SIOPE-brain tumour study. J Neurooncol. 2013 May;113(1):127–134.
Journal cover image

Published In

J Neurooncol

DOI

EISSN

1573-7373

Publication Date

May 2013

Volume

113

Issue

1

Start / End Page

127 / 134

Location

United States

Related Subject Headings

  • Treatment Outcome
  • Temozolomide
  • Oncology & Carcinogenesis
  • Neoplasm Grading
  • Male
  • Irinotecan
  • Humans
  • Glioma
  • Female
  • Dacarbazine