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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.

Publication ,  Journal Article
Warren, KE; Gururangan, S; Geyer, JR; McLendon, RE; Poussaint, TY; Wallace, D; Balis, FM; Berg, SL; Packer, RJ; Goldman, S; Minturn, JE ...
Published in: J Neurooncol
February 2012

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/m(2)/d IV followed by TMZ 75 mg/m(2)/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.

Duke Scholars

Published In

J Neurooncol

DOI

EISSN

1573-7373

Publication Date

February 2012

Volume

106

Issue

3

Start / End Page

643 / 649

Location

United States

Related Subject Headings

  • Young Adult
  • Tumor Suppressor Proteins
  • Temozolomide
  • Retrospective Studies
  • Proportional Hazards Models
  • Oncology & Carcinogenesis
  • Male
  • Ki-67 Antigen
  • Kaplan-Meier Estimate
  • Humans
 

Citation

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MLA
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Warren, K. E., Gururangan, S., Geyer, J. R., McLendon, R. E., Poussaint, T. Y., Wallace, D., … Kun, L. E. (2012). 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. J Neurooncol, 106(3), 643–649. https://doi.org/10.1007/s11060-011-0709-z
Warren, Katherine E., Sri Gururangan, J Russell Geyer, Roger E. McLendon, Tina Young Poussaint, Dana Wallace, Frank M. Balis, et al. “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.J Neurooncol 106, no. 3 (February 2012): 643–49. https://doi.org/10.1007/s11060-011-0709-z.
Warren, Katherine E., et al. “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.J Neurooncol, vol. 106, no. 3, Feb. 2012, pp. 643–49. Pubmed, doi:10.1007/s11060-011-0709-z.
Warren KE, Gururangan S, Geyer JR, McLendon RE, Poussaint TY, Wallace D, Balis FM, Berg SL, Packer RJ, Goldman S, Minturn JE, Pollack IF, Boyett JM, Kun LE. 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. J Neurooncol. 2012 Feb;106(3):643–649.
Journal cover image

Published In

J Neurooncol

DOI

EISSN

1573-7373

Publication Date

February 2012

Volume

106

Issue

3

Start / End Page

643 / 649

Location

United States

Related Subject Headings

  • Young Adult
  • Tumor Suppressor Proteins
  • Temozolomide
  • Retrospective Studies
  • Proportional Hazards Models
  • Oncology & Carcinogenesis
  • Male
  • Ki-67 Antigen
  • Kaplan-Meier Estimate
  • Humans