Ignite Creation Date:
2024-05-05 @ 10:00 AM
Last Modification Date:
2024-10-26 @ 9:03 AM
Study NCT ID:
NCT00002986
Status:
COMPLETED
Last Update Posted:
2013-02-20
First Post:
1999-11-01
Brief Title:
Chemotherapy in Treating Patients With Recurrent Malignant Glioma
Sponsor:
Duke University
Organization:
Duke University
Study Overview
Official Title:
Phase I Treatment of Adults With Primary Malignant Glioma With Topotecan NSC 609699 Plus BCNU NSC 409962
Status:
COMPLETED
Status Verified Date:
2013-02
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 I trial to study the effectiveness of topotecan plus carmustine in patients with recurrent primary malignant glioma
PURPOSE Phase I trial to study the effectiveness of topotecan plus carmustine in patients with recurrent primary malignant glioma
Detailed Description:
OBJECTIVES
Determine the maximum tolerated dose of topotecan administered in combination with a fixed dose of carmustine
Determine the toxic effects of topotecan and carmustine in patients with recurrent primary malignant glioma
OUTLINE Topotecan is administered by an ambulatory infusion pump for 72 hours each week Topotecan dose escalation is carried out in cohorts of three patients Dose escalation is continued until toxic effects or disease progression is observed in these patients Carmustine is administered over 1 hour every 6 weeks on the same day as the first topotecan dose for that week
Three patients will be treated at an initial dose level of topotecan and if one of these patients experience dose limiting toxicity DLT an additional
3 patients must be treated at this dose level without further DLT in order for dose escalation to proceed The MTD is the highest dose at which DLT occurs in no more than 1 of 6 patients
Patients are evaluated after every 6 week cycle
PROJECTED ACCRUAL An estimated 18-36 patients will be entered
Determine the maximum tolerated dose of topotecan administered in combination with a fixed dose of carmustine
Determine the toxic effects of topotecan and carmustine in patients with recurrent primary malignant glioma
OUTLINE Topotecan is administered by an ambulatory infusion pump for 72 hours each week Topotecan dose escalation is carried out in cohorts of three patients Dose escalation is continued until toxic effects or disease progression is observed in these patients Carmustine is administered over 1 hour every 6 weeks on the same day as the first topotecan dose for that week
Three patients will be treated at an initial dose level of topotecan and if one of these patients experience dose limiting toxicity DLT an additional
3 patients must be treated at this dose level without further DLT in order for dose escalation to proceed The MTD is the highest dose at which DLT occurs in no more than 1 of 6 patients
Patients are evaluated after every 6 week cycle
PROJECTED ACCRUAL An estimated 18-36 patients will be entered
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 |
|---|---|---|---|
| CDR0000065521 | OTHER | NCI | None |
| DUMC-000224-01-1R4 | None | None | None |
| DUMC-000224-00-2R3 | None | None | None |
| DUMC-0348-99-2R2 | None | None | None |
| DUMC-223-97-2 | None | None | None |
| DUMC-229-98-2R1 | None | None | None |
| SB-DUMC-229-98-2R1 | None | None | None |
| NCI-G97-1242 | None | None | None |