Ignite Creation Date:
2024-05-05 @ 11:20 AM
Last Modification Date:
2024-10-26 @ 9:05 AM
Study NCT ID:
NCT00005954
Status:
COMPLETED
Last Update Posted:
2013-06-20
First Post:
2000-07-05
Brief Title:
Temozolomide in Treating Patients With Brain Metastases
Sponsor:
Duke University
Organization:
Duke University
Study Overview
Official Title:
Phase II Treatment of Adults With Brain Metastases With Temodar
Status:
COMPLETED
Status Verified Date:
2009-10
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 temozolomide in treating patients who have brain metastases
PURPOSE Phase II trial to study the effectiveness of temozolomide in treating patients who have brain metastases
Detailed Description:
OBJECTIVES
Determine the activity of temozolomide in patients with brain metastases
Determine the toxicity of this treatment in these patients
OUTLINE Patients are stratified according to type of primary cancer lung carcinoma vs breast carcinoma vs malignant melanoma vs renal cell carcinoma vs colorectal carcinoma vs other
Patients receive oral temozolomide daily on days 1-7 and 15-21 Treatment repeats every 28 days for up to 12 courses in the absence of disease progression or unacceptable toxicity
PROJECTED ACCRUAL A total of 180 patients 30 per stratum will be accrued for this study
Determine the activity of temozolomide in patients with brain metastases
Determine the toxicity of this treatment in these patients
OUTLINE Patients are stratified according to type of primary cancer lung carcinoma vs breast carcinoma vs malignant melanoma vs renal cell carcinoma vs colorectal carcinoma vs other
Patients receive oral temozolomide daily on days 1-7 and 15-21 Treatment repeats every 28 days for up to 12 courses in the absence of disease progression or unacceptable toxicity
PROJECTED ACCRUAL A total of 180 patients 30 per stratum 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 |
|---|---|---|---|
| CDR0000067934 | OTHER | NCI | None |
| DUMC-2114-02-12R3 | None | None | None |
| NCI-G00-1798 | None | None | None |