Ignite Creation Date:
2024-05-05 @ 11:23 AM
Last Modification Date:
2024-10-26 @ 9:06 AM
Study NCT ID:
NCT00014300
Status:
COMPLETED
Last Update Posted:
2012-09-24
First Post:
2001-04-10
Brief Title:
Glufosfamide in Treating Patients With Recurrent Glioblastoma Multiforme
Sponsor:
European Organisation for Research and Treatment of Cancer - EORTC
Organization:
European Organisation for Research and Treatment of Cancer - EORTC
Study Overview
Official Title:
Open Label Phase II Study On Glufosfamide Administered As A 60 Minute Infusion Every 3 Weeks In Recurrent Glioblastoma Multiforme
Status:
COMPLETED
Status Verified Date:
2012-09
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 glufosfamide in treating patients who have recurrent glioblastoma multiforme
PURPOSE Phase II trial to study the effectiveness of glufosfamide in treating patients who have recurrent glioblastoma multiforme
Detailed Description:
OBJECTIVES I Determine the activity of glufosfamide in terms of objective response rate andor progression-free survival at 6 months in patients with recurrent glioblastoma multiforme II Determine the duration of objective response in patients treated with this regimen III Determine the toxic effects and pharmacokinetic profile of this regimen in these patients
OUTLINE This is a multicenter study Patients receive glufosfamide IV over 60 minutes on day 1 Treatment repeats every 3 weeks in the absence of disease progression or unacceptable toxicity Patients with stable disease receive treatment for a minimum of 6 months or until progression Patients with an objective complete response receive a maximum of 2 additional courses of treatment after confirmation of response Patients are followed every 6 weeks until progression
PROJECTED ACCRUAL A total of 28 patients will be accrued for this study
OUTLINE This is a multicenter study Patients receive glufosfamide IV over 60 minutes on day 1 Treatment repeats every 3 weeks in the absence of disease progression or unacceptable toxicity Patients with stable disease receive treatment for a minimum of 6 months or until progression Patients with an objective complete response receive a maximum of 2 additional courses of treatment after confirmation of response Patients are followed every 6 weeks until progression
PROJECTED ACCRUAL A total of 28 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 |
|---|---|---|---|
| EORTC-16994G-26002 | None | None | None |