Title {1} | Phase I/II trial of meclofenamate in progressive MGMT-methylated glioblastoma under temozolomide second-line therapy – the MecMeth/NOA-24 trial |
Trial registration {2a and 2b}. | EudraCT No. 2021-000708-39, registration date: 08 February 2021. |
Protocol version {3} | AUTHOR Version \* MERGEFORMAT Version 2.0, 02.07.2021 |
Funding {4} | MecMeth/NOA-24 is an investigator-initiated trial. The trial is funded by the German Federal Ministry of Education and Research (grant 01EN2008). The trial is an official trial of the Neurooncology Working Group (NOA) of the German Cancer Society. |
Author details {5a} |
Thomas Zeyen1, Anna-Laura Potthoff2, Robert Nemeth3, Dieter H. Heiland4,5, Michael C. Burger6, Joachim P. Steinbach6, Peter Hau7, Ghazaleh Tabatabai8, Martin Glas9, Uwe Schlegel10, Oliver Grauer11, Dietmar Krex12, Oliver Schnell4,5, Roland Goldbrunner13, Michael Sabel14, Niklas Thon15, Daniel Delev16, Hans Clusmann16, Clemens Seidel17, Erdem Güresir2, Matthias Schmid3, Patrick Schuss2, Frank A. Giordano18, Alexander Radbruch19, Albert Becker20, Johannes Weller1, Christina Schaub1, Hartmut Vatter2, Judith Schilling21, Frank Winkler22, Ulrich Herrlinger1, Matthias Schneider2 1Division of Clinical Neurooncology, Department of Neurology and Center of Integrated Oncology, University Hospital Bonn, Bonn, Germany 2Department of Neurosurgery and Center of Integrated Oncology, University Hospital Bonn, Bonn, Germany 3Institute of Medical Biometry, Informatics and Epidemiology, University Hospital Bonn, Bonn, Germany 4Department of Neurosurgery, University of Freiburg, Freiburg, Germany 5Faculty of Medicine, University of Freiburg, Freiburg, Germany 6Dr. Senckenberg Institute of Neurooncology, Goethe-University Hospital, Frankfurt am Main, Germany 7Department of Neurology and Wilhelm Sander-NeuroOncology Unit, University Hospital Regensburg, Regensburg, Germany 8Interdisciplinary Division of Neurooncology, University of Tübingen, Tübingen, Germany 9Division of Clinical Neurooncology, Department of Neurology, University Hospital Essen, Essen, Germany 10Department of Neurology, University Hospital Knappschaftskrankenhaus, Ruhr-Universität Bochum, Bochum, Germany 11Department of Neurology, University of Münster, Münster, Germany 12Department of Neurosurgery, University of Dresden, Dresden, Germany 13Department of Neurosurgery, University of Cologne, Cologne, Germany 14Department of Neurosurgery, University of Düsseldorf, Düsseldorf, Germany 15Department of Neurosurgery, Ludwig Maximillian University of Munich and German Cancer Consortium, Partner Site Munich, Munich, Germany 16Department of Neurosurgery, University Hospital RWTH Aachen, Aachen, Germany 17Department of Radiotherapy and Radiation Oncology, University of Leipzig, Leipzig, Germany 18Department of Radiation Oncology, University Hospital Bonn, Bonn, Germany 19Department of Neuroradiology, University Hospital Bonn, Bonn, Germany 20Department of Neuropathology, University Hospital Bonn, Bonn, Germany 21Clinical Study Core Unit Bonn, Institute of Clinical Chemistry and Clinical Pharmacology, University Bonn 22Department of Neurology, University Hospital Heidelberg, Neurooncology Program at the National Center for Tumor Disease, German Cancer Consortium (DKTK), Clinical Cooperation Unit Neurooncology, German Cancer Research Center (DKFZ), Heidelberg, Germany |
Name and contact information for the trial sponsor {5b} |
Rheinische Friedrich-Wilhelms-University of Bonn, represented by the Faculty of Medicine of the University of Bonn, represented by the Dean of the Faculty of the Medical Faculty, Venusberg-Campus 1, D-53127 Bonn, Germany Sponsor Delegated Person and Coordinating Investigator: Prof. Dr. med. Ulrich Herrlinger, Head Division of Clinical Neurooncology, Department of Neurology and Center of Integrated Oncology University Hospital Bonn Venusberg-Campus 1, D-53127 Bonn Tel.: 0049 228 28731241 Fax: 0049 228 28719043 Email: Ulrich.Herrlinger@ukbonn.de Representative of Coordinating Investigator/Principal Investigator: Dr. med. Matthias Schneider, Department of Neurosurgery and Center of Integrated Oncology University Hospital Bonn Venusberg-Campus 1, D-53127 Bonn Tel.: 0049 228 28710162 Fax: 0049 228 287 11366 Email: Matthias.Schneider@ukbonn.de |
Role of sponsor {5c} |
MecMeth/NOA-24 is an investigator-initiated trial. The financial sponsor (German Federal Ministry of Education and Research) had no role in the study design and will not have any role in collection, management, analysis and interpretation of data, writing and submission of the study report for publication. The legal sponsor Rheinische Friedrich-Wilhelms-University of Bonn with his sponsor-delegated person Prof. Ulrich Herrlinger and the MecMeth/NOA-24 study group consisting of the authors of the current publication, however, have ultimate authority over all of these activities. |