Avastin / Irinotecan in Patients With Recurrent or Progressive Malignant Glioma (AVIRMA01-09)
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT01144988|
Recruitment Status : Unknown
Verified August 2011 by Medical University Innsbruck.
Recruitment status was: Recruiting
First Posted : June 16, 2010
Last Update Posted : August 2, 2011
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.
|Condition or disease||Intervention/treatment||Phase|
|Recurrent Malignant Glioma||Drug: Bevacizumab / Irinotecan||Phase 2|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||35 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|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|
|Study Start Date :||March 2010|
|Estimated Primary Completion Date :||March 2013|
|Estimated Study Completion Date :||March 2013|
Drug: Bevacizumab / Irinotecan
- 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 ]
- 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 ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01144988
|Contact: Guenther Stockhammer, MD, Prof.||email@example.com|
|Contact: Markus Hutterer, MDfirstname.lastname@example.org|
|Medical University Innsbruck, Department for Neurology||Recruiting|
|Innsbruck, Austria, A-6020|
|Contact: Guenther Stockhammer, MD, Prof. email@example.com|
|Contact: Martha Nowosielski, MD Martha.Nowosielski@i-med.ac.at|
|Principal Investigator: Guenther Stockhammer, MD, Prof.|
|Sub-Investigator: Martha Nowosielski, MD|
|Sub-Investigator: Markus Glatzer, MD|
|Paracelsus Medical University, Christian Doppler Klinik||Recruiting|
|Salzburg, Austria, 5020|
|Contact: Markus Hutterer, MD firstname.lastname@example.org|
|Principal Investigator: Stefan Golaszewski, MD|
|Sub-Investigator: Markus Hutterer, MD|
|Principal Investigator:||Guenther Stockhammer, MD, Prof.||Department for Neurology, Medical University Innsbruck|