Ignite Creation Date:
2024-05-05 @ 11:31 AM
Last Modification Date:
2024-10-26 @ 9:09 AM
Study NCT ID:
NCT00079092
Status:
COMPLETED
Last Update Posted:
2021-09-09
First Post:
2004-03-08
Brief Title:
Thalidomide and Procarbazine in Treating Patients With Recurrent or Progressive Malignant Glioma
Sponsor:
Wake Forest University Health Sciences
Organization:
Wake Forest University Health Sciences
Study Overview
Official Title:
A Phase II Trial Of Thalidomide And Procarbazine In Adults With RecurrentProgressive Gliomas
Status:
COMPLETED
Status Verified Date:
2021-09
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 Thalidomide may stop the growth of malignant glioma by stopping blood flow to the tumor Drugs used in chemotherapy such as procarbazine work in different ways to stop tumor cells from dividing so they stop growing or die Combining thalidomide with procarbazine may kill more tumor cells
PURPOSE This phase II trial is studying how well giving thalidomide together with procarbazine works in treating patients with recurrent or progressive malignant glioma
PURPOSE This phase II trial is studying how well giving thalidomide together with procarbazine works in treating patients with recurrent or progressive malignant glioma
Detailed Description:
OBJECTIVES
Primary
Determine the response rate in patients with recurrent or progressive malignant glioma treated with thalidomide and procarbazine
Secondary
Determine the progression-free survival of patients treated with this regimen
Determine the overall survival of patients treated with this regimen
Determine the quality of life of patients treated with this regimen
Determine the toxicity of this regimen in these patients
OUTLINE This is a multicenter study
Patients receive oral procarbazine once daily on days 1-5 and oral thalidomide once daily on days 1-28 Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity
Quality of life is assessed at baseline and then before every odd course
Patients are followed every 2 months
PROJECTED ACCRUAL A total of 23-55 patients will be accrued for this study
Primary
Determine the response rate in patients with recurrent or progressive malignant glioma treated with thalidomide and procarbazine
Secondary
Determine the progression-free survival of patients treated with this regimen
Determine the overall survival of patients treated with this regimen
Determine the quality of life of patients treated with this regimen
Determine the toxicity of this regimen in these patients
OUTLINE This is a multicenter study
Patients receive oral procarbazine once daily on days 1-5 and oral thalidomide once daily on days 1-28 Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity
Quality of life is assessed at baseline and then before every odd course
Patients are followed every 2 months
PROJECTED ACCRUAL A total of 23-55 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 |
|---|---|---|---|
| NCI-6358 | None | None | None |
| CCCWFU-91202 | None | None | None |