NCT00165360

Prolonged Daily Temozolomide for Low-Grade Glioma

A Phase II Study of Prolonged Daily Temozolomide for Low-Grade Glioma

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 46 (actual)
• Sponsor: Dana-Farber Cancer Institute · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

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.

Detailed description

* 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.

Conditions

• Glioma
• Astrocytoma
• Oligodendroglioma

Interventions

Type	Name	Description
DRUG	Temozolomide	Given once daily for 49 days followed by 28 days with no drug for a maximum of a year and a half

Timeline

• Start date: 2001-09-01
• Primary completion: 2006-12-01
• Completion: 2009-09-01
• First posted: 2005-09-14
• Last updated: 2009-11-02

Locations

2 sites across 1 country: United States