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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.

PURPOSE: Phase II trial to study the effectiveness of temozolomide in treating patients who have brain metastases.


Clinical Trial Description

OBJECTIVES:

- Determine the activity of temozolomide in patients with brain metastases.

- Determine the toxicity of this treatment in these patients.

OUTLINE: Patients are stratified according to type of primary cancer (lung carcinoma vs breast carcinoma vs malignant melanoma vs renal cell carcinoma vs colorectal carcinoma vs other).

Patients receive oral temozolomide daily on days 1-7 and 15-21. Treatment repeats every 28 days for up to 12 courses in the absence of disease progression or unacceptable toxicity.

PROJECTED ACCRUAL: A total of 180 patients (30 per stratum) will be accrued for this study. ;


Study Design

Primary Purpose: Treatment


Related Conditions & MeSH terms


NCT number NCT00005954
Study type Interventional
Source Duke University
Contact
Status Completed
Phase Phase 2
Start date August 2000
Completion date June 2003

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