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Journal of Neuro-Oncology

, Volume 106, Issue 2, pp 409–415 | Cite as

Phase II study of Gleevec® plus hydroxyurea (HU) in adults with progressive or recurrent meningioma

  • David A. ReardonEmail author
  • Andrew D. Norden
  • Annick Desjardins
  • James J. Vredenburgh
  • James E. HerndonII
  • April Coan
  • John H. Sampson
  • Sridharan Gururangan
  • Katherine B. Peters
  • Roger E. McLendon
  • Julie A. Norfleet
  • Eric S. Lipp
  • Jan Drappatz
  • Patrick Y. Wen
  • Henry S. Friedman
Clinical Study – Patient Study

Abstract

We prospectively evaluated the efficacy and safety of imatinib plus hydroxyurea in patients with progressive/recurrent meningioma. A total of 21 patients with progressive/recurrent meningioma were enrolled in this dual center, single-arm, phase II trial. All patients received 500 mg of hydroxyurea twice a day. Imatinib was administered at 400 mg/day for patients not on CYP3A enzyme inducing anti-epileptic drugs (EIAEDs) and at 500 mg twice a day for patients on EIAEDs. The primary endpoint was progression-free survival at 6 months (PFS-6) and secondary endpoints were safety, radiographic response rate, and overall survival (OS). Best radiographic response was stable disease and was observed in 14 patients (67%). PFS-6 for all patients, those with grade I tumors (n = 8) and those with grade II or III tumors (n = 13) was 61.9, 87.5 and 46.2%, respectively. Patients with grade II or III tumors had poorer PFS and OS than those with grade I tumors, (P = 0.025 and P = 0.018) respectively. The only grade 3 or greater adverse event occurring in ≥10% of patients was anemia (10%). Imatinib plus hydroxyurea is well tolerated among patients with meningioma but has modest anti-tumor activity for this indication.

Keywords

Meningioma Platelet-derived growth factor receptor Imatinib mesylate Hydroxyurea 

Abbreviations

OS

Overall survival

PFS

Progression-free survival

mg

Milligram

EIAEDs

CYP3A enzyme inducing anti-epileptic drugs

KPS

Karnofsky performance status

PD

Progressive disease

STR

Stereotactic radiosurgery

XRT

External beam radiotherapy

CNS

Central nervous system

PDGFR

Platelet derived growth factor receptor

STR

Subtotal resection

SRS

Stereotactic radiosurgery

Notes

Acknowledgments

This study was financially supported by grants P50 NS20023 and R37 CA011898 from NIH, Department of Health and Human Services, Bethesda, Maryland and a research grant from Novartis Pharmaceuticals. The investigators wish to thank Wendy Gentry for her assistance in the preparation of this manuscript.

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Copyright information

© Springer Science+Business Media, LLC. 2011

Authors and Affiliations

  • David A. Reardon
    • 1
    • 2
    • 3
    Email author
  • Andrew D. Norden
    • 7
  • Annick Desjardins
    • 2
    • 4
  • James J. Vredenburgh
    • 2
    • 4
  • James E. HerndonII
    • 5
  • April Coan
    • 5
  • John H. Sampson
    • 2
  • Sridharan Gururangan
    • 2
    • 3
  • Katherine B. Peters
    • 2
    • 4
  • Roger E. McLendon
    • 6
  • Julie A. Norfleet
    • 2
  • Eric S. Lipp
    • 2
  • Jan Drappatz
    • 7
  • Patrick Y. Wen
    • 7
  • Henry S. Friedman
    • 2
    • 3
  1. 1.Duke University Medical CenterDurhamUSA
  2. 2.Department of Surgery, The Preston Robert Tisch Brain Tumor CenterDuke University Medical CenterDurhamUSA
  3. 3.Department of Pediatrics, The Preston Robert Tisch Brain Tumor CenterDuke University Medical CenterDurhamUSA
  4. 4.Department of Medicine, The Preston Robert Tisch Brain Tumor CenterDuke University Medical CenterDurhamUSA
  5. 5.Department of Biostatistics, The Preston Robert Tisch Brain Tumor CenterDuke University Medical CenterDurhamUSA
  6. 6.Departments of Neurobiology and Pathology, The Preston Robert Tisch Brain Tumor CenterDuke University Medical CenterDurhamUSA
  7. 7.The Center for Neuro-OncologyDana Farber Cancer InstituteBostonUSA

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