A Phase II Trial Of Thalidomide And Procarbazine In Adults With Recurrent/Progressive Gliomas
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.
Interventional
Masking: Open Label, Primary Purpose: Treatment
Response rate by CT scan and MRI at baseline, pre-odd cycles, and study completion
No
Glenn J. Lesser, MD
Principal Investigator
Comprehensive Cancer Center of Wake Forest University
United States: Federal Government
CDR0000354204
NCT00079092
January 2004
Name | Location |
---|---|
CCOP - Upstate Carolina | Spartanburg, South Carolina 29303 |
CCOP - Southeast Cancer Control Consortium | Winston-Salem, North Carolina 27104-4241 |
CCOP - Central Illinois | Springfield, Illinois 62526 |
CCOP - Greenville | Greenville, South Carolina 29615 |
Wake Forest University Comprehensive Cancer Center | Winston-Salem, North Carolina 27157-1096 |