NCT00079092

Thalidomide and Procarbazine in Treating Patients With Recurrent or Progressive Malignant Glioma

A Phase II Trial Of Thalidomide And Procarbazine In Adults With Recurrent/Progressive Gliomas

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 18 (estimated)
• Sponsor: Wake Forest University Health Sciences · Academic / Other
• Sex: All
• Age: 18 Years – 120 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Brain and Central Nervous System Tumors

Interventions

Type	Name	Description
DRUG	procarbazine hydrochloride
DRUG	thalidomide

Timeline

• Start date: 2004-01-01
• Primary completion: 2006-03-21
• Completion: 2006-03-21
• First posted: 2004-03-09
• Last updated: 2021-09-09

Locations

5 sites across 1 country: United States