Hydroxyurea With or Without Imatinib Mesylate in Treating Patients With Recurrent or Progressive Meningioma
Recruitment status was: Recruiting
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.
Brain and Central Nervous System Tumors
Drug: imatinib mesylate
|Study Design:||Allocation: Randomized
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||IMATINIB Plus Hydroxyurea in the Treatment of Recurrent or Progressive Meningiomas: a Randomized Phase II Study|
- Progression-free survival, defined as ≥ 25% increase in tumor volume or new tumor on MRI [ Designated as safety issue: No ]
- Survival [ Designated as safety issue: No ]
- Response rate according to MacDonald criteria [ Designated as safety issue: No ]
- Toxicity as assessed by NCI CTCAE v. 3.0 [ Designated as safety issue: Yes ]
|Study Start Date:||June 2009|
Experimental: Arm I
Patients receive oral hydroxyurea twice daily and oral imatinib mesylate once daily in the absence of disease progression or unacceptable toxicity.
Given orallyDrug: imatinib mesylate
Experimental: Arm II
Patients receive oral hydroxyurea twice daily in the absence of disease progression or unacceptable toxicity.
- Assess the progression-free survival of patients with recurrent or progressive meningiomas treated with hydroxyurea with vs without imatinib mesylate after surgery and radiotherapy.
- 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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00904735
|Ospedale Civile Avellino|
|Bologna, Italy, I-40139|
|Azienda Ospedaliero Careggi|
|Florence, Italy, 50139|
|Istituto Nazionale Neurologico Carlo Besta|
|Milan, Italy, 20133|
|Ospedale Civile di Rovigo|
|Rovigo, Italy, 45100|
|Study Chair:||Alba A. Brandes, MD||Ospedale Bellaria|