Ignite Creation Date:
2024-05-05 @ 11:21 AM
Last Modification Date:
2024-10-26 @ 9:05 AM
Study NCT ID:
NCT00006358
Status:
COMPLETED
Last Update Posted:
2018-06-26
First Post:
2000-10-04
Brief Title:
Temozolomide Plus Thalidomide in Treating Patients With Recurrent or Progressive Brain Tumor
Sponsor:
Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
Organization:
Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
Study Overview
Official Title:
Phase II Evaluation of Temozolomide SCH52365 and Thalidomide for the Treatment of Recurrent and Progressive Glioblastoma Multiforme
Status:
COMPLETED
Status Verified Date:
2018-06
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 Thalidomide may stop the growth of cancer by stopping blood flow to the tumor
PURPOSE Phase II trial to study the effectiveness of combining temozolomide and thalidomide in treating patients who have recurrent or progressive brain tumor
PURPOSE Phase II trial to study the effectiveness of combining temozolomide and thalidomide in treating patients who have recurrent or progressive brain tumor
Detailed Description:
OBJECTIVES I Determine the efficacy of temozolomide and thalidomide in patients with recurrent or progressive supratentorial glioblastoma multiforme or gliosarcoma II Determine the toxicity of this regimen in these patients
OUTLINE This is a multicenter study Patients receive oral temozolomide once daily on days 1-5 and oral thalidomide daily on days 1-28 Treatment repeats every 28 days for a maximum of 24 courses in the absence of disease progression or unacceptable toxicity Patients are followed at 1 month and then for survival
PROJECTED ACCRUAL A total of 40 patients will be accrued for this study within 4-5 months
OUTLINE This is a multicenter study Patients receive oral temozolomide once daily on days 1-5 and oral thalidomide daily on days 1-28 Treatment repeats every 28 days for a maximum of 24 courses in the absence of disease progression or unacceptable toxicity Patients are followed at 1 month and then for survival
PROJECTED ACCRUAL A total of 40 patients will be accrued for this study within 4-5 months
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 |
|---|---|---|---|
| CDR0000068227 | REGISTRY | PDQ Physician Data Query | None |