RATIONALE: Drugs used in chemotherapy, such as hydroxyurea, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Imatinib mesylate may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. It is not yet known whether hydroxyurea is more effective when given alone or together with imatinib mesylate in treating patients with meningioma. PURPOSE: This randomized phase II trial is studying how well hydroxyurea works compared with giving hydroxyurea together with imatinib mesylate in treating patients with recurrent or progressive meningioma.
OBJECTIVES: Primary * Assess the progression-free survival of patients with recurrent or progressive meningiomas treated with hydroxyurea with vs without imatinib mesylate after surgery and radiotherapy. Secondary * Determine the overall survival, and response rate of patients treated with this regimen. * 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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
76
Given orally
Given orally
Ospedale Civile Avellino
Avellino, Italy
RECRUITINGOspedale Bellaria
Bologna, Italy
RECRUITINGAzienda Ospedaliero Careggi
Florence, Italy
RECRUITINGIstituto Nazionale Neurologico Carlo Besta
Milan, Italy
RECRUITINGOspedale Civile di Rovigo
Rovigo, Italy
RECRUITINGProgression-free survival, defined as ≥ 25% increase in tumor volume or new tumor on MRI
Survival
Response rate according to MacDonald criteria
Toxicity as assessed by NCI CTCAE v. 3.0
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