Neoplasms

All Conditions

Rare Diseases

Glioma

Neoplasms, Neuroepithelial

Neuroectodermal Tumors

Neuroectodermal Tumors, Primitive

Neoplasms, Germ Cell and Embryonal

Neoplasms by Histologic Type

Neoplasms, Glandular and Epithelial

Neoplasms, Nerve Tissue

Neuroepithelioma

All Drugs and Chemicals

Antineoplastic Agents

Antibodies

Antibodies, Monoclonal

Nimotuzumab

Immunoglobulins

Antineoplastic Agents, Immunological

nimotuzumab

Udo Bode, Prof. MD

Determination of efficiency of nimotuzumab in children with diffuse intrinsic pontine glioma.

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.

Nimotuzumab in Children With Intrinsic Pontine Glioma

Phase III Study on the Effectiveness of OSAG 101 (Theraloc®)in Newly Diagnosed Intrinsic Pontine Gliomas of Children and Adolescents

Children's Medical Hospital, University of Bonn, Germany

University of Wuerzburg

Dept. of Statistics, University of Dortmund, Germany

CRM Biometrics GmbH

Heinrich-Heine University, Duesseldorf

Dr. von Haunersches Children's Medical Hospital, University of Munich, Germany

Children's Medical Hospital, University of Homburg/Saar, Homburg/Saar, Germany

Children's Medical Hospital, Medical School Hannover, Hannover, Germany

Children's Medical Hospital, University of Leipzig, Leipzig, Germany

Children's Medical Hospital, University of Muenster, Muenster, Germany

Burdenko Neurosurgery Institute

Istituto Nazinonale Tumori, Div. of Paediatric Oncology,Milano, Italy

Oncoscience AG

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization	Link
Nimotuzumab in Children With Intrinsic Pontine Glioma	NCT00561691	Diffuse Instrin...	nimotuzumab	3 Years - 20 Years	Oncoscience AG
Nimotuzumab in Children With Intrinsic Pontine Glioma	NCT00561691	Diffuse Instrin...	nimotuzumab	3 Years - 20 Years	Oncoscience AG

Spots Global Cancer Trial Database for diffuse instrinsic ponitine glioma