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Erschienen in: Journal of Neuro-Oncology 3/2012

01.02.2012 | Clinical Study - Patient Study

A phase II study of O6-benzylguanine and temozolomide in pediatric patients with recurrent or progressive high-grade gliomas and brainstem gliomas: a Pediatric Brain Tumor Consortium study

verfasst von: Katherine E. Warren, Sri Gururangan, J. Russell Geyer, Roger E. McLendon, Tina Young Poussaint, Dana Wallace, Frank M. Balis, Stacey L. Berg, Roger J. Packer, Stewart Goldman, Jane E. Minturn, Ian F. Pollack, James M. Boyett, Larry E. Kun

Erschienen in: Journal of Neuro-Oncology | Ausgabe 3/2012

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Abstract

To estimate the sustained (≥8 weeks) objective response rate in pediatric patients with recurrent or progressive high-grade gliomas (HGG, Stratum A) or brainstem gliomas (BSG, Stratum B) treated with the combination of O6-benzylguanine (O6BG) and temozolomide® (TMZ). Patients received O6BG 120 mg/m2/d IV followed by TMZ 75 mg/m2/d orally daily for 5 consecutive days of each 28-day course. The target objective response rate to consider the combination active was 17%. A two-stage design was employed. Forty-three patients were enrolled; 41 were evaluable for response, including 25 patients with HGG and 16 patients with BSG. The combination of O6BG and TMZ was tolerable, and the primary toxicities were myelosuppression and gastrointestinal symptoms. One sustained (≥8 weeks) partial response was observed in the HGG cohort; no sustained objective responses were observed in the BSG cohort. Long-term (≥6 courses) stable disease (SD) was observed in 4 patients in Stratum A and 1 patient in Stratum B. Of the 5 patients with objective response or long-term SD, 3 underwent central review with 2 reclassified as low-grade gliomas. The combination of O6BG and TMZ did not achieve the target response rate for activity in pediatric patients with recurrent or progressive HGG and BSG.
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Metadaten
Titel
A phase II study of O6-benzylguanine and temozolomide in pediatric patients with recurrent or progressive high-grade gliomas and brainstem gliomas: a Pediatric Brain Tumor Consortium study
verfasst von
Katherine E. Warren
Sri Gururangan
J. Russell Geyer
Roger E. McLendon
Tina Young Poussaint
Dana Wallace
Frank M. Balis
Stacey L. Berg
Roger J. Packer
Stewart Goldman
Jane E. Minturn
Ian F. Pollack
James M. Boyett
Larry E. Kun
Publikationsdatum
01.02.2012
Verlag
Springer US
Erschienen in
Journal of Neuro-Oncology / Ausgabe 3/2012
Print ISSN: 0167-594X
Elektronische ISSN: 1573-7373
DOI
https://doi.org/10.1007/s11060-011-0709-z

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