Recurrent Malignant Glioma Clinical Trial
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
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.
n/a
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