Phase II Treatment of Adults With Newly Diagnosed, Progressive or Recurrent Primary Malignant Anaplastic Oligodendroglioma With Temodal
OBJECTIVES: I. Determine the activity of temozolomide in patients with newly diagnosed,
progressive, or recurrent anaplastic oligodendroglioma. II. Determine the toxicity of this
drug in this patient population.
OUTLINE: Patients are stratified according to disease characteristics (newly diagnosed
anaplastic oligodendroglioma versus recurrent anaplastic oligodendroglioma). Patients
receive oral temozolomide once daily on days 1-5. Treatment repeats every 28 days. Patients
with progressive or recurrent disease (at baseline) continue treatment in the absence of
disease progression or unacceptable toxicity. Patients with newly diagnosed disease continue
treatment for a maximum of 4 courses before radiotherapy in the absence of disease
progression or unacceptable toxicity. Patients with responding disease may receive an
additional 6 courses after completion of radiotherapy. (Radiotherapy is not part of study
treatment.) Patients are followed every 8 weeks for 2 years.
PROJECTED ACCRUAL: A maximum of 60 patients (30 per stratum) will be accrued for this study.
Primary Purpose: Treatment
Henry S. Friedman, MD
United States: Federal Government
|Duke Comprehensive Cancer Center||Durham, North Carolina 27710|