Ignite Creation Date:
2025-12-25 @ 2:07 AM
Ignite Modification Date:
2025-12-26 @ 2:34 AM
Study NCT ID:
NCT00036660
Status:
COMPLETED
Last Update Posted:
2020-04-06
First Post:
2002-05-13
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
SarCNU in Treating Patients With Recurrent Malignant Glioma
Sponsor:
NCIC Clinical Trials Group
Organization:
Study Overview
Official Title:
A Phase II Study of SarCNU (NSC 364432) in Patients With Malignant Glioma
Status:
COMPLETED
Status Verified Date:
2020-04
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 sarCNU in treating patients who have recurrent malignant glioma.
PURPOSE: Phase II trial to study the effectiveness of sarCNU in treating patients who have recurrent malignant glioma.
Detailed Description:
OBJECTIVES:
* Determine the efficacy of SarCNU, in terms of objective response and duration of response, in patients with recurrent malignant gliomas.
* Determine the qualitative and quantitative toxic effects of this drug in these patients.
* Determine the time to progression and survival of patients treated with this drug.
OUTLINE: This is a multicenter study.
Patients receive oral SarCNU on days 1, 5, and 9. Treatment repeats every 6 weeks for up to 4 courses in the absence of disease progression or unacceptable toxicity.
Patients are followed at 4 weeks and then every 3 months thereafter.
PROJECTED ACCRUAL: A total of 15-30 patients will be accrued for this study within 12-18 months.
* Determine the efficacy of SarCNU, in terms of objective response and duration of response, in patients with recurrent malignant gliomas.
* Determine the qualitative and quantitative toxic effects of this drug in these patients.
* Determine the time to progression and survival of patients treated with this drug.
OUTLINE: This is a multicenter study.
Patients receive oral SarCNU on days 1, 5, and 9. Treatment repeats every 6 weeks for up to 4 courses in the absence of disease progression or unacceptable toxicity.
Patients are followed at 4 weeks and then every 3 months thereafter.
PROJECTED ACCRUAL: A total of 15-30 patients will be accrued for this study within 12-18 months.
Study Oversight
Has Oversight DMC:
True
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?: