A Phase II Study of Prolonged Daily Temozolomide for Low-Grade Glioma
- 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.
Interventional
Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
To determine the effects temozolomide has on low-grade gliomas
3 years
No
Patrick Wen, MD
Principal Investigator
Dana-Farber Cancer Institute
United States: Institutional Review Board
01-111
NCT00165360
September 2001
September 2009
Name | Location |
---|---|
Dana-Farber Cancer Institute | Boston, Massachusetts 02115 |
Brigham and Women's Hospital | Boston, Massachusetts 02115 |