Phase II Trial of Continuous Dose Temozolomide in Patients With Newly Diagnosed Pure and Mixed Anaplastic Oligodendroglioma
- Determine progression-free survival of patients with newly diagnosed anaplastic
oligodendroglioma (AO) or mixed oligoastrocytoma (MOA) treated with temozolomide.
- Determine the response rate in these patients.
- Assess the quality of life of patients with AO or MOA treated with this regimen.
OUTLINE: This is a parallel-group, multicenter study. Patients are stratified according to
disease type (anaplastic oligodendroglioma vs mixed oligoastrocytoma).
Patients receive oral temozolomide once daily on days 1-7 and 15-21. Treatment repeats every
28 days for up to 8 courses in the absence of disease progression or unacceptable toxicity.
Quality of life is assessed at baseline, before courses 1, 3, 5, and 7, every 3 months for
the first year after completion of treatment, every 4 months for the second year, every 6
months for the third and fourth years, and once a year thereafter.
After completion of study treatment, patients are followed periodically.
PROJECTED ACCRUAL: A total of 60 patients will be accrued for this study.
Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Survival of Last Patient
David M. Peereboom, MD
Case Comprehensive Cancer Center
United States: Food and Drug Administration
|Case Comprehensive Cancer Center||Cleveland, Ohio 44106-5065|