A Phase II Study of Imatinib Mesylate Plus Hydroxyurea in the Treatment of Patients With Recurrent/Progressive Meningioma
- Evaluate the activity of imatinib mesylate and hydroxyurea, as measured by 6-month
progression-free survival, in patients with recurrent or progressive meningioma.
- Evaluate the progression-free survival (PFS)
- Overall survival (OS),
- Objective response rate among patients treated with this regimen.
OUTLINE: This is an open-label study.
Patients receive oral imatinib mesylate once or twice daily and oral hydroxyurea twice daily
on days 1-28. Courses repeat every 28 days in the absence of disease progression or
PROJECTED ACCRUAL: A total of 21 patients will be accrued for this study.
Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Progression-free Survival at 6 Months
Percentage of participants surviving six months from the start of study treatment without progression of disease. PFS was defined as the time from the date of study treatment initiation to the date of the first documented progression according to the Macdonald criteria, or death due to any cause.
From the date of study treatment initiation to the date of the first documented progression or death from any cause, whichever came first, assessed up to 69 months. For each participant, PFS was assessed at 6 months after treatment initiation.
David A. Reardon, MD
Duke Cancer Institute
United States: Institutional Review Board
|Duke Cancer Institute||Durham, North Carolina 27710|