Ignite Creation Date:
2024-05-05 @ 4:58 PM
Last Modification Date:
2024-10-26 @ 9:26 AM
Study NCT ID:
NCT00354913
Status:
COMPLETED
Last Update Posted:
2013-01-18
First Post:
2006-07-19
Brief Title:
Imatinib Mesylate and Hydroxyurea in Treating Patients With Recurrent or Progressive Meningioma
Sponsor:
Duke University
Organization:
Duke University
Study Overview
Official Title:
A Phase II Study of Imatinib Mesylate Plus Hydroxyurea in the Treatment of Patients With RecurrentProgressive Meningioma
Status:
COMPLETED
Status Verified Date:
2012-12
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
RATIONALE Imatinib mesylate may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth 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 Giving imatinib mesylate together with hydroxyurea may kill more tumor cells
PURPOSE This phase II trial is studying how well giving imatinib mesylate together with hydroxyurea works in treating patients with recurrent or progressive meningioma
PURPOSE This phase II trial is studying how well giving imatinib mesylate together with hydroxyurea works in treating patients with recurrent or progressive meningioma
Detailed Description:
OBJECTIVES
Primary
Evaluate the activity of imatinib mesylate and hydroxyurea as measured by 6-month progression-free survival in patients with recurrent or progressive meningioma
Secondary
Evaluate the progression-free survival PFS
Overall survival OS
Objective response rate among patients treated with this regimen
OUTLINE This is an open-label study
Patients receive oral imatinib mesylate once or twice daily and oral hydroxyurea twice daily on days 1-28 Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity
PROJECTED ACCRUAL A total of 21 patients will be accrued for this study
Primary
Evaluate the activity of imatinib mesylate and hydroxyurea as measured by 6-month progression-free survival in patients with recurrent or progressive meningioma
Secondary
Evaluate the progression-free survival PFS
Overall survival OS
Objective response rate among patients treated with this regimen
OUTLINE This is an open-label study
Patients receive oral imatinib mesylate once or twice daily and oral hydroxyurea twice daily on days 1-28 Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity
PROJECTED ACCRUAL A total of 21 patients will be accrued for this study
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| NOVARTIS-DUMC-7082-05-4R0 | None | None | None |
| DUMC-7082-05-4R0 | None | None | None |