NCT00883298

Bi-weekly Temozolomide Plus Bevacizumab for Adult Patients With Recurrent Glioblastoma Multiforme

Phase II Study of Bi-Weekly Temozolomide Plus Bevacizumab for Adult Patients With Recurrent Glioblastoma Multiforme

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 30 (actual)
• Sponsor: Center for Neurosciences, Tucson · Academic / Other
• Sex: All
• Age: 18 Years – 83 Years
• Healthy volunteers: Not accepted

Summary

Primary objective - to determine the 6-month progression free survival (PFS) of adult patients with recurrent glioblastoma multiforme/gliosarcoma treated with bi-weekly temozolomide plus (Avastin) bevacizumab. Secondary objectives - to determine radiographic response including specialized MRI sequences, safety and overall survival of adult patients with with recurrent glioblastoma multiforme/gliosarcoma treated with bi-weekly temozolomide plus bevacizumab (Avastin). Additionally, tumor DNA (MGMT) analysis as it relates to survival will be evaluated.

Detailed description

This is a phase II study of the combination of Avastin and temozolomide for patients with recurrent glioblastoma multiforme. Avastin is administered intravenously at a dose of 10 mg/kg on days 1 and 15 every 28 days and temozolomide is administered at a dose of 100 mg/m2 on days 1-5 and 15-19 every 28 days (one cycle). Patients will have a baseline MRI, an MRI scan after the first cycle and every other cycle after that. If there is no evidence of disease progression or unacceptable toxicity, patients will receive one year of therapy. If there is evidence of added benefit (eg: tumor regression), patients can stay on treatment longer than one year, per investigator discretion.

Conditions

• Recurrent Glioblastoma Multiforme
• Recurrent Gliosarcoma

Interventions

Type	Name	Description
DRUG	temozolomide and bevacizumab	oral temozolomide 100 mg/m2 days 1-5 \& 15-19 every 28-day cycle plus intravenous bevacizumab 10 mg/kg days 1 \& 5 every 28-day cycle

Timeline

• Start date: 2009-04-01
• Primary completion: 2014-12-01
• Completion: 2014-12-01
• First posted: 2009-04-17
• Last updated: 2017-03-30

Locations

1 site across 1 country: United States