Thalidomide and Procarbazine in Treating Patients With Recurrent or Progressive Malignant Glioma
- Conditions
- Brain and Central Nervous System Tumors
- Registration Number
- NCT00079092
- Lead Sponsor
- Wake Forest University Health Sciences
- 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.
- 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 18
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Response rate by CT scan and MRI at baseline, pre-odd cycles, and study completion
- Secondary Outcome Measures
Name Time Method Quality of life by FACT-Br, FACIT-F and Karnofsky performance status (PS) at baseline, pre-odd cycles, and study completion Progression-free survival by CT scan, MRI, and follow up form at baseline, pre-odd cycles, and study completion Toxicity by evaluation form at baseline, pre-odd cycles, and study completion Overall survival by follow-up form at study completion
Trial Locations
- Locations (5)
CCOP - Central Illinois
🇺🇸Decatur, Illinois, United States
CCOP - Upstate Carolina
🇺🇸Spartanburg, South Carolina, United States
CCOP - Greenville
🇺🇸Greenville, South Carolina, United States
CCOP - Southeast Cancer Control Consortium
🇺🇸Goldsboro, North Carolina, United States
Wake Forest University Comprehensive Cancer Center
🇺🇸Winston-Salem, North Carolina, United States