Ignite Creation Date:
2024-05-05 @ 11:23 AM
Last Modification Date:
2024-10-26 @ 9:06 AM
Study NCT ID:
NCT00014443
Status:
TERMINATED
Last Update Posted:
2023-01-09
First Post:
2001-04-10
Brief Title:
Topotecan and Thalidomide in Treating Patients With Recurrent or Refractory Malignant Glioma
Sponsor:
Rush University Medical Center
Organization:
Rush University Medical Center
Study Overview
Official Title:
A Pilot Study Of Hycamtin Topotecan And Thalomid Thalidomide In Patients With Recurrent Malignant Gliomas
Status:
TERMINATED
Status Verified Date:
2023-01
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Poor enrollment
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 I trial to study the effectiveness of combining topotecan and thalidomide in treating patients who have recurrent or refractory malignant glioma
PURPOSE Phase I trial to study the effectiveness of combining topotecan and thalidomide in treating patients who have recurrent or refractory malignant glioma
Detailed Description:
OBJECTIVES
Determine tumor response rate duration of response time to disease progression and overall survival of patients with recurrent or refractory malignant glioma treated with topotecan and thalidomide
Determine safety and tolerance of this regimen in these patients
OUTLINE Patients receive topotecan IV continuously on days 1-21 and oral thalidomide daily on days 1-28 Treatment repeats every 28 days for a maximum of 6 courses in the absence of disease progression or unacceptable toxicity
Patients are followed every 2 months
PROJECTED ACCRUAL Approximately 20 patients will be accrued for this study within 2 years
Determine tumor response rate duration of response time to disease progression and overall survival of patients with recurrent or refractory malignant glioma treated with topotecan and thalidomide
Determine safety and tolerance of this regimen in these patients
OUTLINE Patients receive topotecan IV continuously on days 1-21 and oral thalidomide daily on days 1-28 Treatment repeats every 28 days for a maximum of 6 courses in the absence of disease progression or unacceptable toxicity
Patients are followed every 2 months
PROJECTED ACCRUAL Approximately 20 patients will be accrued for this study within 2 years
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
True
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 |
|---|---|---|---|
| NCI-V01-1651 | None | None | None |
| RUSH-G101 | None | None | None |