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Original Article

Phase II study of Gleevec plus hydroxyurea in adults with progressive or recurrent low-grade glioma†

  1. David A. Reardon MD1,2,3,‡,*,
  2. Annick Desjardins MD1,4,
  3. James J. Vredenburgh MD1,4,
  4. James E. Herndon II PhD5,
  5. April Coan MS5,
  6. Sridharan Gururangan MD1,2,3,
  7. Katherine B. Peters MD1,4,
  8. Roger McLendon MD1,6,
  9. Sith Sathornsumetee MD7,
  10. Jeremy N. Rich MD8,
  11. Eric S. Lipp MD1,2,
  12. Dorothea Janney RN1,4,
  13. Henry S. Friedman MD1,2,3

Article first published online: 27 FEB 2012

DOI: 10.1002/cncr.26541

Issue

Cancer

Cancer

Volume 118, Issue 19, pages 4759–4767, 1 October 2012

Additional Information

How to Cite

Reardon, D. A., Desjardins, A., Vredenburgh, J. J., Herndon, J. E., Coan, A., Gururangan, S., Peters, K. B., McLendon, R., Sathornsumetee, S., Rich, J. N., Lipp, E. S., Janney, D. and Friedman, H. S. (2012), Phase II study of Gleevec plus hydroxyurea in adults with progressive or recurrent low-grade glioma. Cancer, 118: 4759–4767. doi: 10.1002/cncr.26541

Author Information

  1. 1

    The Preston Robert Tisch Brain Tumor Center, Duke University Medical Center, Durham, North Carolina

  2. 2

    Department of Surgery, Duke University Medical Center, Durham, North Carolina

  3. 3

    Department of Pediatrics, Duke University Medical Center, Durham, North Carolina

  4. 4

    Departent of Medicine, Duke University Medical Center, Durham, North Carolina

  5. 5

    Department of Biostatistics, Duke University Medical Center, Durham, North Carolina

  6. 6

    Department of Pathology, Duke University Medical Center, Durham, North Carolina

  7. 7

    Department of Medicine (Neurology), Faculty of Medicine at Siriraj Hospital, Mahidol University, Bangkok, Thailand

  8. 8

    Department of Stem Cell Biology and Regenerative Medicine, Cleveland Clinic, Cleveland, Ohio

  1. ‡

    Fax: (919) 684-6674

*Duke University Medical Center, Box 3624, Durham, NC 27710

  1. †

    In addition to the above investigators, we wish to thank Wendy Gentry for her assistance in the preparation of this manuscript.

  2. ‡

    Fax: (919) 684-6674

Publication History

  1. Issue published online: 19 SEP 2012
  2. Article first published online: 27 FEB 2012
  3. Manuscript Accepted: 21 JUN 2011
  4. Manuscript Revised: 26 MAY 2011
  5. Manuscript Received: 15 APR 2011

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Keywords:

  • imatinib;
  • glioma;
  • platelet derived growth factor;
  • astrocytoma;
  • oligodendroglioma

Abstract

BACKGROUND:

We evaluated the efficacy of imatinib plus hydroxyurea in patients with progressive/recurrent low-grade glioma.

METHODS:

A total of 64 patients with recurrent/progressive low-grade glioma were enrolled in this single-center study that stratified patients into astrocytoma and oligodendroglioma cohorts. All patients received 500 mg of hydroxyurea twice a day. Imatinib was administered at 400 mg per day for patients not on enzyme-inducing antiepileptic drugs (EIAEDs) and at 500 mg twice a day if on EIAEDs. The primary endpoint was progression-free survival at 12 months (PFS-12) and secondary endpoints were safety, median progression-free survival, and radiographic response rate.

RESULTS:

Thirty-two patients were enrolled into each cohort. Eleven patients (17%) had before radiotherapy and 24 (38%) had received before chemotherapy. The median PFS and PFS-12 were 11 months and 39%, respectively. Outcome did not differ between the histologic cohorts. No patient achieved a radiographic response. The most common grade 3 or greater adverse events were neutropenia (11%), thrombocytopenia (3%), and diarrhea (3%).

CONCLUSIONS:

Imatinib plus hydroxyurea was well tolerated among recurrent/progressive LGG patients but this regimen demonstrated negligible antitumor activity. Cancer 2012. © 2012 American Cancer Society.

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