Phase II Trial of Continuous Dose Temozolomide in Patients With Newly Diagnosed Anaplastic Oligodendroglioma and Mixed Oligoastrocytoma
Temozolomide has demonstrated clinical antitumor efficacy against malignant gliomas at both
relapse and initial diagnosis. This drug appears to have less adverse effects compared to
other drugs used against brain tumors. Therefore, temozolomide is often better tolerated in
brain tumor patients compared to other brain tumor drugs. The current study builds on
previous research to test the efficacy of chemotherapy alone in patients with anaplastic
oligodendroglioma and mixed oligoastrocytoma.
This study will evaluate response rate, or how the disease size changes in patients, and
survival without disease growth, in patients with anaplastic oligodendroglioma and mixed
oligoastrocytoma treated with temozolomide. Quality of life will also be assessed in this
patient population treated with the study regimen.
Study participants will be treated with the drug temozolomide. This drug will be
administered in oral pills. Temozolomide will be taken for seven consecutive days followed
by seven days without the drug. This treatment schedule of seven days on temozolomide
followed by seven days off will continue throughout the study. Several tests and exams will
be given to closely monitor patients. MRI scans will be performed every 8 weeks to measure
disease response. Temozolomide as a study drug will be given to study participants for a
total of 8 week four cycles. However, treatments will be discontinued due to disease growth
or unacceptable adverse events.
Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Determine progression free survival and response rate in patients with newly diagnosed AO and MOA of Temozolomide given every other week.
Herbert Newton, MD
Ohio State University
United States: Institutional Review Board
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