Bevacizumab and Irinotecan for Patients With Primary Brain Tumors and Progression After Standard Therapy
- Conditions
- Brain NeoplasmsGlioma
- Registration Number
- NCT00463203
- Lead Sponsor
- Rigshospitalet, Denmark
- Brief 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 54
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Primary Outcome Measures
Name Time Method progression-free survival 6 months
- Secondary Outcome Measures
Name Time Method Response rate - Response according to MacDonald criteria 6 months Adverse event according to CTCAE 3.0 6 months
Trial Locations
- Locations (3)
Aalborg University Hospital
🇩🇰Aalborg, Denmark
Rigshospitalet
🇩🇰Copenhagen, Denmark
Odense University Hospital
🇩🇰Odense, Denmark
Aalborg University Hospital🇩🇰Aalborg, Denmark