Hydroxyurea With or Without Imatinib Mesylate in Treating Patients With Recurrent or Progressive Meningioma
- Conditions
- Brain and Central Nervous System Tumors
- Interventions
- Registration Number
- NCT00904735
- Lead Sponsor
- Istituto Scientifico H. San Raffaele
- Brief Summary
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.
- Detailed Description
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.
Recruitment & Eligibility
- Status
- UNKNOWN
- Sex
- All
- Target Recruitment
- 76
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- Not specified
- Arm && Interventions
Group Intervention Description Arm I imatinib mesylate Patients receive oral hydroxyurea twice daily and oral imatinib mesylate once daily in the absence of disease progression or unacceptable toxicity. Arm I hydroxyurea Patients receive oral hydroxyurea twice daily and oral imatinib mesylate once daily in the absence of disease progression or unacceptable toxicity. Arm II hydroxyurea Patients receive oral hydroxyurea twice daily in the absence of disease progression or unacceptable toxicity.
- Primary Outcome Measures
Name Time Method Progression-free survival, defined as ≥ 25% increase in tumor volume or new tumor on MRI
- Secondary Outcome Measures
Name Time Method Survival Response rate according to MacDonald criteria Toxicity as assessed by NCI CTCAE v. 3.0
Trial Locations
- Locations (5)
Azienda Ospedaliero Careggi
🇮🇹Florence, Italy
Ospedale Civile di Rovigo
🇮🇹Rovigo, Italy
Ospedale Civile Avellino
🇮🇹Avellino, Italy
Istituto Nazionale Neurologico Carlo Besta
🇮🇹Milan, Italy
Ospedale Bellaria
🇮🇹Bologna, Italy