Avastin / Irinotecan in Patients With Recurrent or Progressive Malignant Glioma (AVIRMA01-09)
Recruitment status was: Recruiting
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.
|Study Design:||Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Diagnostic
|Official Title:||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|
- To determine the objective tumor response criteria (RR, ORR, ORD) assessed by Standard MRI and FET-/FLT-PET during Avastin / Irinotecan chemotherapy. [ Time Frame: three years ] [ Designated as safety issue: No ]
- Evaluation of the predictive / prognostic value of the VEGF pathway and tumor cell proliferation rate in tumor and vascular cells of malignant gliomas treated with Avastin / Irinotecan Chemotherapy [ Time Frame: three years ] [ Designated as safety issue: No ]
|Study Start Date:||March 2010|
|Estimated Study Completion Date:||March 2013|
|Estimated Primary Completion Date:||March 2013 (Final data collection date for primary outcome measure)|
Drug: Bevacizumab / Irinotecan
Please refer to this study by its ClinicalTrials.gov identifier: NCT01144988
|Medical University Innsbruck, Department for Neurology|
|Innsbruck, Austria, A-6020|
|Paracelsus Medical University, Christian Doppler Klinik|
|Salzburg, Austria, 5020|
|Principal Investigator:||Guenther Stockhammer, MD, Prof.||Department for Neurology, Medical University Innsbruck|