Ignite Creation Date:
2025-12-24 @ 12:07 PM
Ignite Modification Date:
2026-02-25 @ 5:33 PM
Study NCT ID:
NCT00049361
Status:
COMPLETED
Last Update Posted:
2021-09-09
First Post:
2002-11-12
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Radiation Therapy Plus Thalidomide and Temozolomide in Treating Patients With Newly Diagnosed Brain Metastases
Sponsor:
Wake Forest University Health Sciences
Organization:
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:
Is a FDA Regulated Drug?:
Is a FDA Regulated Device?:
Is an Unapproved Device?:
Is a PPSD?:
Is a US Export?:
Is an FDA AA801 Violation?: