Ignite Creation Date:
2024-05-05 @ 11:25 AM
Last Modification Date:
2024-10-26 @ 9:07 AM
Study NCT ID:
NCT00036660
Status:
COMPLETED
Last Update Posted:
2020-04-06
First Post:
2002-05-13
Brief Title:
SarCNU in Treating Patients With Recurrent Malignant Glioma
Sponsor:
NCIC Clinical Trials Group
Organization:
Canadian Cancer Trials Group
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:
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 |
|---|---|---|---|
| CAN-NCIC-IND142 | OTHER | None | None |
| CDR0000068652 | OTHER | PDQ | None |