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

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.

• Authors: David A Reardon, Andrew D Norden, Annick Desjardins, James J Vredenburgh, James E Herndon 2nd, 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
• Journal: Journal of neuro-oncology (J Neurooncol) Vol. 106 Issue 2 Pg. 409-15 (Jan 2012) ISSN: 1573-7373 [Electronic] United States
• PMID: 21938530 (Publication Type: Clinical Trial, Phase II, Journal Article, Multicenter Study, Research Support, N.I.H., Extramural, Research Support, Non-U.S. Gov't)

Chemical References

• Benzamides
• Piperazines
• Pyrimidines
• Imatinib Mesylate
• Hydroxyurea

Topics

• Adult
• Aged
• Aged, 80 and over
• Antineoplastic Combined Chemotherapy Protocols (therapeutic use)
• Benzamides
• Disease Progression
• Disease-Free Survival
• Female
• Humans
• Hydroxyurea (administration & dosage)
• Imatinib Mesylate
• Kaplan-Meier Estimate
• Male
• Meningeal Neoplasms (drug therapy, mortality, pathology)
• Meningioma (drug therapy, mortality, pathology)
• Middle Aged
• Neoplasm Grading
• Neoplasm Recurrence, Local (drug therapy, pathology)
• Piperazines (administration & dosage)
• Pyrimidines (administration & dosage)