Ignite Creation Date:
2024-05-05 @ 11:22 AM
Last Modification Date:
2024-10-26 @ 9:03 AM
Study NCT ID:
NCT00002988
Status:
COMPLETED
Last Update Posted:
2013-06-20
First Post:
1999-11-01
Brief Title:
Irinotecan Plus Carmustine in Treating Patients With Recurrent Primary Malignant Glioma
Sponsor:
Duke University
Organization:
Duke University
Study Overview
Official Title:
Phase I Treatment of Adults With Primary Malignant Glioma With Irinotecan CPT-11 NSC 6616348 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 irinotecan plus carmustine in treating patients who have recurrent primary malignant glioma
PURPOSE Phase I trial to study the effectiveness of irinotecan plus carmustine in treating patients who have recurrent primary malignant glioma
Detailed Description:
OBJECTIVES I Determine the maximum tolerated dose of irinotecan administered in combination with a fixed dose of carmustine in patients with recurrent primary malignant glioma II Determine the toxic effects of irinotecan and carmustine in these patients
OUTLINE This is a dose escalation study of irinotecan Patients receive irinotecan IV over 90 minutes weekly on weeks 1-4 and carmustine IV over 1 hour on weeks 1-6 Treatment continues in the absence of disease progression or unacceptable toxicity Cohorts of 3-6 patients receive escalating doses of irinotecan until the maximum tolerated dose MTD is determined The MTD is defined as the dose at which no more than 1 of 6 patients experiences dose limiting toxicities
PROJECTED ACCRUAL Approximately 18-36 patients will be accrued for this study
OUTLINE This is a dose escalation study of irinotecan Patients receive irinotecan IV over 90 minutes weekly on weeks 1-4 and carmustine IV over 1 hour on weeks 1-6 Treatment continues in the absence of disease progression or unacceptable toxicity Cohorts of 3-6 patients receive escalating doses of irinotecan until the maximum tolerated dose MTD is determined The MTD is defined as the dose at which no more than 1 of 6 patients experiences dose limiting toxicities
PROJECTED ACCRUAL Approximately 18-36 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 |
|---|---|---|---|
| CDR0000065523 | OTHER | NCI | None |
| DUMC-000564-00-3R3 | None | None | None |
| DUMC-0509-99-3R2 | None | None | None |
| DUMC-0509-99-4R1 | None | None | None |
| DUMC-427-98-3R1 | None | None | None |
| DUMC-461-97-3 | None | None | None |
| NCI-G97-1243 | None | None | None |