Ignite Creation Date:
2024-05-05 @ 11:22 AM
Last Modification Date:
2024-10-26 @ 9:05 AM
Study NCT ID:
NCT00006119
Status:
COMPLETED
Last Update Posted:
2021-02-21
First Post:
2000-08-03
Brief Title:
Hydroxyurea in Treating Patients With Recurrent andor Unresectable Meningioma
Sponsor:
UNICANCER
Organization:
UNICANCER
Study Overview
Official Title:
Phase II Study of Hydroxyurea for the Treatment of Recurrent andor Nonoperable Meningioma
Status:
COMPLETED
Status Verified Date:
2021-02
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 Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die
PURPOSE Phase II trial to study the effectiveness of hydroxyurea in treating patients who have recurrent andor unresectable meningioma
PURPOSE Phase II trial to study the effectiveness of hydroxyurea in treating patients who have recurrent andor unresectable meningioma
Detailed Description:
OBJECTIVES
Determine complete partial or stable response to hydroxyurea in patients with recurrent andor nonresectable meningioma
Determine response at 2 years to this regimen in these patients
Determine overall and disease free survival of these patients after this regimen
Determine quality of life of these patients
Determine the toxicities of this regimen in these patients
OUTLINE This is a multicenter study Patients are stratified according to grade of disease I vs II or III
Patients receive oral hydroxyurea daily for 2 years
Quality of life is assessed before treatment then every 3 months for 2 years
PROJECTED ACCRUAL A total of 60 patients 30 per stratum will be accrued for this study
Determine complete partial or stable response to hydroxyurea in patients with recurrent andor nonresectable meningioma
Determine response at 2 years to this regimen in these patients
Determine overall and disease free survival of these patients after this regimen
Determine quality of life of these patients
Determine the toxicities of this regimen in these patients
OUTLINE This is a multicenter study Patients are stratified according to grade of disease I vs II or III
Patients receive oral hydroxyurea daily for 2 years
Quality of life is assessed before treatment then every 3 months for 2 years
PROJECTED ACCRUAL A total of 60 patients 30 per stratum will be accrued for this study
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
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 |
|---|---|---|---|
| EU-20018 | None | None | None |
| FRE-FNCLCC-98009 | None | None | None |