Clinical Trial: Temozolomide in Treating Patients With Newly Diagnosed Anaplastic Oligodendroglioma or Mixed Oligoastrocytoma
Study Status: Active, not recruiting
Recruit Status: Active, not recruiting
Study Type: Interventional
Official Title: Phase II Trial of Continuous Dose Temozolomide in Patients With Newly Diagnosed Pure and Mixed Anaplastic Oligodendroglioma
Brief Summary:
RATIONALE: Drugs used in chemotherapy, such as temozolomide, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing.
PURPOSE: This phase II trial is studying how well temozolomide works in treating patients with newly diagnosed anaplastic oligodendroglioma or mixed oligoastrocytoma.
Detailed Summary:
OBJECTIVES:
- 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.
Sponsor: The Cleveland Clinic
Current Primary Outcome: Progression-Free Survival [ Time Frame: Survival of Last Patient ]
Original Primary Outcome: Progression-Free Survival
Current Secondary Outcome: Toxicity [ Time Frame: Post-Treatment ]
Original Secondary Outcome: Toxicity
Information By: The Cleveland Clinic
Dates:
Date Received: November 16, 2006
Date Started: August 2005
Date Completion: December 2016
Last Updated: August 6, 2016
Last Verified: August 2016
