Ignite Creation Date:
2024-05-05 @ 10:23 AM
Last Modification Date:
2024-10-26 @ 9:05 AM
Study NCT ID:
NCT00005951
Status:
COMPLETED
Last Update Posted:
2014-08-22
First Post:
2000-07-05
Brief Title:
Irinotecan Plus Temozolomide 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 Temodar NSC 362856
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 Combining more than one drug may kill more tumor cells
PURPOSE Phase I trial to study the effectiveness of irinotecan plus temozolomide in treating patients who have recurrent primary malignant glioma
PURPOSE Phase I trial to study the effectiveness of irinotecan plus temozolomide in treating patients who have recurrent primary malignant glioma
Detailed Description:
OBJECTIVES
Determine the maximum tolerated dose of irinotecan administered in combination with temozolomide in patients with recurrent primary malignant glioma
Determine the toxicity of this combination therapy in these patients
OUTLINE This is a dose escalation study of irinotecan Patients are stratified according to concurrent anticonvulsants Dilantin Tegretol or phenobarbital vs other anticonvulsants or none
Patients receive irinotecan IV over 90 minutes on days 1 8 15 and 22 and oral temozolomide on days 1-5 Treatment continues every 43 days 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 preceding that at which 2 of 6 patients experience dose limiting toxicities
PROJECTED ACCRUAL Not specified
Determine the maximum tolerated dose of irinotecan administered in combination with temozolomide in patients with recurrent primary malignant glioma
Determine the toxicity of this combination therapy in these patients
OUTLINE This is a dose escalation study of irinotecan Patients are stratified according to concurrent anticonvulsants Dilantin Tegretol or phenobarbital vs other anticonvulsants or none
Patients receive irinotecan IV over 90 minutes on days 1 8 15 and 22 and oral temozolomide on days 1-5 Treatment continues every 43 days 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 preceding that at which 2 of 6 patients experience dose limiting toxicities
PROJECTED ACCRUAL Not specified
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 |
|---|---|---|---|
| CDR0000067931 | None | None | None |
| DUMC-1087-02-6R3 | None | None | None |
| DUMC-001087-006R1 | None | None | None |
| DUMC-1067-99-6 | None | None | None |
| NCI-G00-1795 | None | None | None |
| DUMC-001087-01-6R2 | None | None | None |