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Clinical Trial 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 I trial to study the effectiveness of combining topotecan and thalidomide in treating patients who have recurrent or refractory malignant glioma.


Clinical Trial Description

OBJECTIVES: - Determine tumor response rate, duration of response, time to disease progression, and overall survival of patients with recurrent or refractory malignant glioma treated with topotecan and thalidomide. - Determine safety and tolerance of this regimen in these patients. OUTLINE: Patients receive topotecan IV continuously on days 1-21 and oral thalidomide daily on days 1-28. Treatment repeats every 28 days for a maximum of 6 courses in the absence of disease progression or unacceptable toxicity. Patients are followed every 2 months. PROJECTED ACCRUAL: Approximately 20 patients will be accrued for this study within 2 years. ;


Study Design


Related Conditions & MeSH terms


NCT number NCT00014443
Study type Interventional
Source Rush University Medical Center
Contact
Status Terminated
Phase Phase 2
Start date August 2000
Completion date December 2003

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