Brain and Central Nervous System Tumors Clinical Trial
Official title:
IMATINIB Plus Hydroxyurea in the Treatment of Recurrent or Progressive Meningiomas: a Randomized Phase II Study
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.
;
Allocation: Randomized, Masking: Open Label, Primary Purpose: Treatment
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