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Brief Title: Thalidomide and Procarbazine in Treating Patients With Recurrent or Progressive Malignant Glioma
Official Title: A Phase II Trial Of Thalidomide And Procarbazine In Adults With Recurrent/Progressive Gliomas
Study ID: NCT00079092
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.
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
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
CCOP - Upstate Carolina, Spartanburg, South Carolina, United States
Name: Glenn J. Lesser, MD
Affiliation: Wake Forest University Health Sciences
Role: PRINCIPAL_INVESTIGATOR
Name: Edward G. Shaw, MD
Affiliation: Wake Forest University Health Sciences
Role: STUDY_CHAIR
Name: Volker W. Stieber, MD
Affiliation: Wake Forest University Health Sciences
Role: PRINCIPAL_INVESTIGATOR