Hydroxyurea With or Without Imatinib Mesylate in Treating Patients With Recurrent or Progressive Meningioma
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|ClinicalTrials.gov Identifier: NCT00904735|
Recruitment Status : Unknown
Verified July 2009 by National Cancer Institute (NCI).
Recruitment status was: Recruiting
First Posted : May 20, 2009
Last Update Posted : August 12, 2013
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.
|Condition or disease||Intervention/treatment||Phase|
|Brain and Central Nervous System Tumors||Drug: hydroxyurea Drug: imatinib mesylate||Phase 2|
- 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.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||76 participants|
|Masking:||None (Open Label)|
|Official Title:||IMATINIB Plus Hydroxyurea in the Treatment of Recurrent or Progressive Meningiomas: a Randomized Phase II Study|
|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.
Drug: imatinib mesylate
Experimental: Arm II
Patients receive oral hydroxyurea twice daily in the absence of disease progression or unacceptable toxicity.
- Progression-free survival, defined as ≥ 25% increase in tumor volume or new tumor on MRI
- Response rate according to MacDonald criteria
- Toxicity as assessed by NCI CTCAE v. 3.0
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00904735
|Ospedale Civile Avellino||Recruiting|
|Contact: Contact Person 39-0825-203-232|
|Bologna, Italy, I-40139|
|Contact: Alba A. Brandes, MD 39-51-622-5102 firstname.lastname@example.org|
|Azienda Ospedaliero Careggi||Recruiting|
|Florence, Italy, 50139|
|Contact: Contact Person 39-055-427-7111|
|Istituto Nazionale Neurologico Carlo Besta||Recruiting|
|Milan, Italy, 20133|
|Contact: Contact Person 39-02-2394-2341|
|Ospedale Civile di Rovigo||Recruiting|
|Rovigo, Italy, 45100|
|Contact: Contact Person 39-0425-393-016|
|Study Chair:||Alba A. Brandes, MD||Ospedale Bellaria|