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.
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.
Study Type
INTERVENTIONAL
Purpose
TREATMENT
Masking
NONE
Enrollment
18
CCOP - Central Illinois
Decatur, Illinois, United States
CCOP - Southeast Cancer Control Consortium
Goldsboro, North Carolina, United States
Wake Forest University Comprehensive Cancer Center
Winston-Salem, North Carolina, United States
CCOP - Greenville
Greenville, South Carolina, United States
Response rate by CT scan and MRI 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
Overall survival by follow-up form at study completion
Quality of life by FACT-Br, FACIT-F and Karnofsky performance status (PS) at baseline, pre-odd cycles, and study completion
Toxicity by evaluation form at baseline, pre-odd cycles, and study completion
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CCOP - Upstate Carolina
Spartanburg, South Carolina, United States