Phase II Trial of Temodal 4 Hourly in Progressive Breast Cancer
OBJECTIVES: I. Assess the therapeutic activity of temozolomide in terms of tumor response,
progression free and overall survival in women with advanced breast cancer. II. Assess the
extent of ATase depletion and DNA methylation in the peripheral blood of these patients
undergoing this regimen and investigate the relationship between these parameters and tumor
OUTLINE: Patients receive oral temozolomide every 4 hours for a total of 5 doses. Treatment
continues every 28 days for a minimum of 2 courses and a maximum of 1 year in the absence of
unacceptable toxicity or disease progression. Patients are followed at 30 days, and then
every 2 months thereafter.
PROJECTED ACCRUAL: A total of 14-30 patients will be accrued for this study.
Primary Purpose: Treatment
Anthony Howell, MD
Christie Hospital NHS Foundation Trust
United States: Federal Government