NCT00657267

Dose-Intense Temozolomide in Recurrent Glioblastoma

Phase 2 Study of Dose-Intense Temozolomide in Recurrent Glioblastoma

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 58 (actual)
• Sponsor: Patrick Y. Wen, MD · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

Temozolomide (Temodar) is an FDA approved medication for the treatment of newly diagnosed glioblastomas. In this study, we will be using temozolomide to treat recurrent glioblastomas. We will be using a different dose and schedule than the FDA approved dose and schedule. The purpose of this study is to determine if patients that have failed standard temozolomide treatment will respond to temozolomide when given at a different dose and schedule (21 days every 28 days).

Detailed description

* Participants will be given a medication-dosing calendar for each treatment cycle. Each treatment cycle lasts 4 weeks (28 days) during which time they will be taking temozolomide orally once a day for the first three weeks. * At the end of each cycle (day 28, +/- 2 days), the following procedures will be performed: Complete physical examination including a neurological exam; vital signs; a review of current medications and symptoms; blood samples; a pregnancy test for women of child-bearing potential; self-administered quality of life questionnaire; brain MRI or CT scan. * Participants may continue taking temozolomide until their tumor grows or if they experience unacceptable side effects.

Conditions

• Glioblastoma
• Gliosarcoma

Interventions

Type	Name	Description
DRUG	Temozolomide	Taken orally daily for the first three weeks of a four-week cycle.

Timeline

• Start date: 2008-05-01
• Primary completion: 2011-11-01
• Completion: 2013-10-01
• First posted: 2008-04-14
• Last updated: 2014-03-14
• Results posted: 2014-03-14

Locations

6 sites across 1 country: United States