Ignite Creation Date:
2024-05-05 @ 11:26 AM
Last Modification Date:
2024-10-26 @ 9:08 AM
Study NCT ID:
NCT00049361
Status:
COMPLETED
Last Update Posted:
2021-09-09
First Post:
2002-11-12
Brief Title:
Radiation Therapy Plus Thalidomide and Temozolomide in Treating Patients With Newly Diagnosed Brain Metastases
Sponsor:
Wake Forest University Health Sciences
Organization:
Wake Forest University Health Sciences
Study Overview
Official Title:
A Phase II Study Of Whole-Brain Radiation Therapy With Thalidomide And Temozolomide In Patients With Newly Diagnosed Brain Metastases
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 Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die Radiation therapy uses high-energy x-rays to damage tumor cells Thalidomide may stop the growth of cancer by stopping blood flow to the tumor Combining whole-brain radiation therapy with thalidomide and temozolomide may kill more tumor cells
PURPOSE Phase II trial to study the effectiveness of combining whole-brain radiation therapy with thalidomide and temozolomide in treating patients who have newly diagnosed brain metastases
PURPOSE Phase II trial to study the effectiveness of combining whole-brain radiation therapy with thalidomide and temozolomide in treating patients who have newly diagnosed brain metastases
Detailed Description:
OBJECTIVES
Determine the overall median survival time of patients with newly diagnosed brain metastases treated with whole-brain radiotherapy in combination with thalidomide and temozolomide
Determine the radiographic response rate median time to tumor progression and median time to neurologic response and progression in patients treated with this regimen
Determine the cause of death of patients treated with this regimen
Determine the toxicity of this regimen in these patients
Assess quality of life of patients treated with this regimen
OUTLINE This is a multicenter study
Patients undergo radiotherapy daily 5 days a week for 3 weeks Beginning on the day before the first radiation treatment patients receive oral thalidomide once daily and oral temozolomide once daily for 21 days Patients continue to receive thalidomide daily for up to 2 years in the absence of disease progression or unacceptable toxicity
Quality of life is assessed at baseline 1 and 3 months after completing radiotherapy and then every 3 months thereafter
Patients are followed at 1 and 3 months and then every 3 months thereafter
PROJECTED ACCRUAL A total of 62 patients will be accrued for this study within 10 months
Determine the overall median survival time of patients with newly diagnosed brain metastases treated with whole-brain radiotherapy in combination with thalidomide and temozolomide
Determine the radiographic response rate median time to tumor progression and median time to neurologic response and progression in patients treated with this regimen
Determine the cause of death of patients treated with this regimen
Determine the toxicity of this regimen in these patients
Assess quality of life of patients treated with this regimen
OUTLINE This is a multicenter study
Patients undergo radiotherapy daily 5 days a week for 3 weeks Beginning on the day before the first radiation treatment patients receive oral thalidomide once daily and oral temozolomide once daily for 21 days Patients continue to receive thalidomide daily for up to 2 years in the absence of disease progression or unacceptable toxicity
Quality of life is assessed at baseline 1 and 3 months after completing radiotherapy and then every 3 months thereafter
Patients are followed at 1 and 3 months and then every 3 months thereafter
PROJECTED ACCRUAL A total of 62 patients will be accrued for this study within 10 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 |
|---|---|---|---|
| NCI-5883 | None | None | None |
| CCCWFU-91102 | None | None | None |