A Phase II Study Of Whole-Brain Radiation Therapy With Thalidomide And Temozolomide In Patients With Newly Diagnosed Brain Metastases
- Determine the overall median survival time of patients with newly diagnosed brain
metastases treated with whole-brain radiotherapy in combination with thalidomide and
- 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.
Masking: Open Label, Primary Purpose: Treatment
Overall median survival
Volker W. Stieber, MD
Comprehensive Cancer Center of Wake Forest University
United States: Federal Government
|CCOP - Upstate Carolina||Spartanburg, South Carolina 29303|
|CCOP - Southeast Cancer Control Consortium||Winston-Salem, North Carolina 27104-4241|
|Comprehensive Cancer Center at Wake Forest University||Winston-Salem, North Carolina 27157-1082|
|CCOP - Central Illinois||Springfield, Illinois 62526|
|CCOP - Greenville||Greenville, South Carolina 29615|