IMATINIB Plus Hydroxyurea in the Treatment of Recurrent or Progressive Meningiomas: a Randomized Phase II Study
- Assess the progression-free survival of patients with recurrent or progressive
meningiomas treated with hydroxyurea with vs without imatinib mesylate after surgery
- Determine the overall survival, and response rate of patients treated with this
- Determine the toxicity of this regimen in these patients.
OUTLINE: This is a multicenter study. Patients are stratified according to WHO grade (I vs
II-III). Patients are randomized to 1 of 2 treatment arms.
- Arm I: Patients receive oral hydroxyurea twice daily and oral imatinib mesylate once
daily in the absence of disease progression or unacceptable toxicity.
- Arm II: Patients receive oral hydroxyurea twice daily in the absence of disease
progression or unacceptable toxicity.
After completion of study therapy, patients are followed for up to 1 year.
Allocation: Randomized, Masking: Open Label, Primary Purpose: Treatment
Progression-free survival, defined as ≥ 25% increase in tumor volume or new tumor on MRI
Alba A. Brandes, MD