NCT00660621

A Phase II Study Of Gliadel, Concomitant Temozolomide And Radiation, Followed By Dose Dense Therapy With Temozolomide Plus Bevacizumab For Newly Diagnosed Malignant High Grade Glioma

• Status: Unknown
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 40 (estimated)
• Sponsor: Kentuckiana Cancer Institute · Academic / Other
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

Summary

To determine the safety and efficacy of surgical resection with Gliadel® 3.85% wafer implantation, followed by concomitant limited field radiation therapy and temozolomide, followed by dose dense temozolomide and bevacizumab in subjects undergoing initial surgery for newly-diagnosed high grade glioma.

Conditions

• Glioma

Interventions

Type	Name	Description
DRUG	Temozolomide and Bevacizumab	Between 14 and 28 days after surgery, all subjects will begin a standard course of post-operative limited field radiation therapy to the tumor site and a surrounding margin with concomitant temozolomide at a daily dose of 75 mg/m2 (7 days/week). No later than 45 days after date of completion of radiation therapy, all subjects will begin dose dense temozolomide at dose of 150 mg/m2 on Days 1-7 and 15-21 of a 28 day cycle with concomitant bevacizumab 10mg/kg administered intravenously every other week.

Timeline

• Start date: 2008-04-01
• Primary completion: 2010-12-01
• Completion: 2010-12-01
• First posted: 2008-04-17
• Last updated: 2010-01-20

Locations

1 site across 1 country: United States