Glioma Clinical Trial
Official title:
A Phase II Study of Prolonged Daily Temozolomide for Low-Grade Glioma
The purpose of this trial is to determine the effects (good and bad) temozolomide has on patients with low-grade glioma. It will also determine whether temozolomide is effective in preventing or delaying future tumor growth.
- Treatment with temozolomide is based upon an 11-week cycle (7 weeks on the drug and 4
weeks off). Patients will receive temozolomide once daily for 49 days, then have 28
days without taking temozolomide.
- Every two to four weeks a physical and neurological examination and blood work will be
performed. A magnetic resonance imaging (MRI) scan of the patient's brain will be done
approximately every three months (before each cycle of treatment).
- Treatment may continue for a maximum of a year and a half based on 6 eleven-week
cycles. The actual duration of therapy will depend upon the response to treatment and
the development of side effects or toxicity.
;
Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
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