NCT01144988

Avastin / Irinotecan in Patients With Recurrent or Progressive Malignant Glioma

An Academic Prospective Single-arm Phase II Clinical Trial for Evaluation of Advanced Functional Neuroimaging Techniques and Molecular Markers in the Course of Anti-angiogenic Therapies in Malignant Gliomas

• Status: Unknown
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 35 (estimated)
• Sponsor: Medical University Innsbruck · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

Malignant glioma are the most common and aggressive primary brain tumors in adults. Despite advances in multimodal treatment including surgery, radiation and chemotherapy, most patients have a dismal prognosis of 9-15 months (Stupp et al., NEJM 2005). A major reason for the aggressiveness of malignant glioma is a pronounced tumor neovascularization, mainly driven by the vascular endothelial growth factor (VEGF) and its receptors. The therapeutic monoclonal antibody Bevacizumab (Avastin®) inhibits the VEGF pathway by binding the VEGF ligand. In Magnetic Resonance Imaging (MRI) this treatment reduces contrast enhancement by restoring both, the blood-brain-barrier and the destabilized vessel integrity. Furthermore, it raises the sensitivity of co-administered chemotherapeutics such as Irinotecan. In conclusion, anti-angiogenic therapy leads to the problem that the routinely used MRI techniques cannot distinguish anti-vascular effects from true anti-tumor effects. The study hypothesis of the clinical trial part is that in 35% of malignant glioma patients Avastin / Irinotecan chemotherapy results in objective tumor responses assessed by standard / functional MRI and FET- /FLT-PET neuroimaging. The study hypothesis for the translational study part is that the expression of the molecular targets of Avastin and Irinotecan in malignant glioma tissue ( = tumor and vascular cells) are predictive for Avastin / Irinotecan therapy induced treatment response measured by functional MRI and FET- / FLT-PET imaging.

Conditions

• Recurrent Malignant Glioma

Interventions

Type	Name	Description
DRUG	Bevacizumab / Irinotecan	Bevacizumab (10mg/kg KG) Irinotecan (125 mg/ m2 or 340 mg/m2 depending on usage of EIAED)

Timeline

• Start date: 2010-03-01
• Primary completion: 2013-03-01
• Completion: 2013-03-01
• First posted: 2010-06-16
• Last updated: 2011-08-02

Locations

2 sites across 1 country: Austria