Spots Global Cancer Trial Database for APG101 in Glioblastoma
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Trial Identification
Brief Title: APG101 in Glioblastoma
Official Title: A Phase II, Randomized, Open-label, Multi-centre Study of Weekly APG101 + Reirradiation Versus Reirradiation in the Treatment of Patients With First or Second Progression of Glioblastoma
Study ID: NCT01071837
Conditions
Study Description
Brief Summary: This is a phase II study of APG101 + reirradiation (RT) versus reirradiation. Patients suffering from a malignant brain tumor called glioblastoma having a first or second progression can be included. They will be randomized to RT or RT + APG101. APG101 is a fusion protein (similar to an antibody) and will be administered as a weekly infusion. Patients can stay in this study as long as they benefit from the participation (no fixed end). In this trial, 30-35 sites in Germany, Austria and Russia take part.
Detailed Description: In this phase II trial, patients with a recurrence / progression of glioblastoma (first or second progression) either not being eligible for tumour resection or having macroscopic residual tumour after resection of the recurrence can be included (tumor size must 1-4 cm in T1-weighted MRI). They must be candidates for a re-irradiation and will then be randomized in a 1:2 ratio to re-irradiation alone or re-irradiation + 400mg APG101 as a weekly intravenous infusion. Radiotherapy (RT) is considered standard of care and not a study procedure. As prior therapies, a first radiotherapy (maximal dose of 60 Gy; at least 8 months since the end of preirradiation), a prior surgery (at least for histology) and at least one Temozolomide-containing chemotherapy are mandatory; patients with prior treatment with bevacizumab, iodine seeds and/or brachytherapy are not eligible. The patients' steroid dose must be stable or decreasing upon inclusion. The number of patients to be included in this study is up to 83 (depending on the statistical 2-step SIMON design). Primary objective: 6 months rate of progression free survival (PFS6). Subjects can participate in this study as long as a clinical benefit is considered by the treating physician. MRI tumour imaging will be carried out every 6 weeks.
Keywords
Eligibility
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
Locations
Medizinische Universität Graz, Universitätsklinik für Neurologie Landeskrankenhaus Graz, Graz, , Austria
Universitätsklinik für Neurologie, Landeskrankenhaus Innsbruck, Innsbruck, , Austria
Landesnervenklinik Wagner-Jauregg, Innere Medizin mit Neuroonkologie, Linz, , Austria
Allgemeines Krankenhaus der Stadt Wien, Klinische Onkologie, Wien, , Austria
Charite Universitätsmedizin Berlin, Klinik für Neurochirugie, Berlin, , Germany
Neurologische Universitätsklinik am Knappschaftskrankenhaus, Bochum, , Germany
Neurologische Universitätsklinik Bonn, Schwerpunkt klinische Neuroonkologie, Bonn, , Germany
Universitätsklinik Dresden, Klinik und Poliklinik für Neurochirurgie, Dresden, , Germany
Klinikum Frankfurt/Oder, Klinik für Strahlentherapie/Radioonkologie, Frankfurt/Oder, , Germany
Universitätsklinik Hamburg, Klinik für Neurochirugie, Hamburg, , Germany
Universitätsklinik Heidelberg, Abteilung Neuroonkologie, Heidelberg, , Germany
Universität Leipzig, Klinik für Strahlentherapie, Leipzig, , Germany
Universitätsmedizin Mannheim, Klinik für Neurochirurgie, Mannheim, , Germany
Philipps-Universität Marburg, Klinik für Neurologie, Marburg, , Germany
LMU München, Klinik und Poliklinik für Strahlentherapie und Radioonkologie, Campus Großhadern & Campus Innenstadt, München, , Germany
Klinik und Poliklinik für Strahlentherapie/Radiologische Onkologie, Klinikum rechts der Isar, TU München, München, , Germany
Städt. Kliniken München GmbH, Klinikum Bogenhausen, Abt. Neurochirurgie, München, , Germany
Klinik und Poliklinik der Universität Regensburg, Im Bezirksklinikum, Regensburg, , Germany
Klinikum Stuttgart, Neurozentrum Neurochirurgie, Stuttgart, , Germany
Universitätsklinikum Tuebingen, Strahlenonkologie, Tuebingen, , Germany
Uniklinik Ulm, Klinik für Strahlentherapie und Radioonkologie, Ulm, , Germany
Contact Details
Name: Wolfgang Wick, MD
Affiliation: University Hospital Heidelberg, Dept. of Neurooncology, Germany
Role: STUDY_DIRECTOR
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