NCT00006358

Temozolomide Plus Thalidomide in Treating Patients With Recurrent or Progressive Brain Tumor

Phase II Evaluation of Temozolomide (SCH52365) and Thalidomide for the Treatment of Recurrent and Progressive Glioblastoma Multiforme

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 44 (actual)
• Sponsor: Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins · Academic / Other
• Sex: All
• Age: 18 Years – 120 Years
• Healthy volunteers: Not accepted

Summary

RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Thalidomide may stop the growth of cancer by stopping blood flow to the tumor. PURPOSE: Phase II trial to study the effectiveness of combining temozolomide and thalidomide in treating patients who have recurrent or progressive brain tumor.

Detailed description

OBJECTIVES: I. Determine the efficacy of temozolomide and thalidomide in patients with recurrent or progressive supratentorial glioblastoma multiforme or gliosarcoma. II. Determine the toxicity of this regimen in these patients. OUTLINE: This is a multicenter study. Patients receive oral temozolomide once daily on days 1-5 and oral thalidomide daily on days 1-28. Treatment repeats every 28 days for a maximum of 24 courses in the absence of disease progression or unacceptable toxicity. Patients are followed at 1 month and then for survival. PROJECTED ACCRUAL: A total of 40 patients will be accrued for this study within 4-5 months.

Conditions

• Brain and Central Nervous System Tumors

Interventions

Type	Name	Description
DRUG	temozolomide
DRUG	thalidomide

Timeline

• Start date: 2000-06-13
• Primary completion: 2003-01-23
• Completion: 2006-07-20
• First posted: 2004-05-26
• Last updated: 2018-06-26

Locations

11 sites across 1 country: United States