NCT00463203

Bevacizumab and Irinotecan for Patients With Primary Brain Tumors and Progression After Standard Therapy

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 54 (estimated)
• Sponsor: Rigshospitalet, Denmark · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

Irinotecan has demonstrated activity in malignant gliomas in multiple phase II studies. The activity is limited, with an approximately 15 % response rate and a progression-free survival of 3-5 months. Given the synergy between irinotecan and bevacizumab in colorectal cancer, and the high-level expression of vascular endothelial growth factor on malignant gliomas, one would expect synergy between bevacizumab and irinotecan against gliomas. Recent data form a small study of 32 patients from Duke University have achieved a response rate of 62% in patients with malignant gliomas. Most included patients had glioblastomas, but this regimen may also have activity in more rare primary malignant brain tumors. The investigators therefore plan to include other primary malignant brain tumors in this study, and the clinical activity will be correlated with biomarkers and PET results of metabolic activity and blood flow. This may result in information that can be used to individualize therapy in the future.

Conditions

• Brain Neoplasms
• Glioma

Interventions

Type	Name	Description
DRUG	Bevacizumab	10 mg/kg every 2 weeks
DRUG	Irinotecan	125 mg/m2 non-EIAED or 340 mg/m2 EIAED every 2 weeks

Timeline

• Start date: 2007-03-01
• Primary completion: 2011-03-01
• Completion: 2011-06-01
• First posted: 2007-04-20
• Last updated: 2011-06-29

Locations

3 sites across 1 country: Denmark