Phase III Study on the Effectiveness of OSAG 101 (Theraloc®)in Newly Diagnosed Intrinsic Pontine Gliomas of Children and Adolescents
Due to the poor prognosis of diffuse intrinsic pontine gliomas, the limited therapy options,
the relevant portion of EGFR expression and the unexpected good response to the therapy with
OSAG 101 in the phase II study, a phase III study was planned in newly diagnosed diffuse
intrinsic pontine gliomas in children and adolescents. A phase II study in patients of
recurrence/resistance high grade glioma in childhood or adolescence showed that, in
particular, a part of the intrinsic pontine glioma response to the monotherapy with OSAG 101
resulting in a reduction in the size of the tumour or stabilisation in the growth of the
tumour. Together with clinical improvement, stabilisation lasted markedly over 6 months in
two thirds of the patients. The current phase III study was scheduled to provide evidence of
the effectiveness in the case of newly diagnosed intrinsic pontine glioma. In this study,
OSAG 101 will be given concomitantly to the only standard therapy for this kind of tumour,
i.e. the fractionated radiotherapy, to show effectiveness in the primary endpoint of median
progression-free survival, the secondary endpoint of median overall survival and the side
effect profile.
Evidence from the median progression-free survival and the side effect profile of this
combination met the expected results and one may consider that combination therapy of this
therapeutic approach with other immunotherapeutic or antiangiogenic approaches and/or mild
chemotherapy could lead to a better prognosis and quality of life for these patients.
Observational
Observational Model: Case-Only, Time Perspective: Prospective
To determine the progression-free survival (PFS) of the combination of monoclonal anti-EGFR antibody OSAG 101 and standard local radiotherapy
week 12, 24, 36
Udo Bode, Prof. MD
Principal Investigator
University Bonn
Germany: Paul-Ehrlich-Institut
OSAG101-BSC05
NCT00561691
April 2006
January 2012
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