Nimotuzumab in Children With HGG

This study has been completed.

Sponsors and Collaborators:	Oncoscience AG Children`s Medical Hospital, University of Bonn, Germany University of Wuerzburg Dept. of Statistics, University of Dortmund, Germany CRM Biometrics GmbH, Rheinbach, Germany Heinrich-Heine University, Duesseldorf Hospital for Children and Adolescents, Augsburg, Germany 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 Essen, Essen, Germany Dept. of Neuropediatrics and Muscle Disorders, University of Freiburg, Germany University of Cologne Universitätsklinikum Hamburg-Eppendorf Krankenhaus der Barmherzigen Brüder, Klinik St. Hedwig, University of Regensburg,Germany
Information provided by:	Oncoscience AG
ClinicalTrials.gov Identifier:	NCT00561873

Purpose

Determination of efficiency of nimotuzumab in children with high grade glioma.

Condition
High Grade Glioma

U.S. FDA Resources

Study Type:	Observational
Study Design:	Case-Only, Prospective
Official Title:	Phase-II-Study of Efficacy of OSAG 101 (Theraloc®) for Adolscent Patients With Recurrent High Grade Glioma

Further study details as provided by Oncoscience AG:

Primary Outcome Measures:

Response rate according to RECIST criteria [ Time Frame: week 8, week 21 ]

Secondary Outcome Measures:

Progress free interval, Toxicity according to CTC criteria, Symptom control [ Time Frame: week 8, week 21 ]

Biospecimen Retention: None Retained

Biospecimen Description:

Enrollment:	45
Study Start Date:	June 2004
Study Completion Date:	February 2007

Detailed Description:

High grade malignant gliomas are tumors grade III and IV according to WHO classification, that originate from oligodendroglia and astrocytes, where the latter are also known as anaplastic astrocytoma(WHO grade III) and glioblastoma(WHO grade IV). This also includes intrinsic pontine gliomas of adolescents, which are usually not documented histologically due to their localisation, but they have a similar clinical progress when compared to high grade malignant astrocytic tumors. Among various molecular alterations, malignant gliomas overexpress EGFR (epidermal growth factor) in nearly 50% of cases, which is particularly pronounced in glioblastoma.(Schlegel 2003) Standard therapy consists of radical surgery as extensive as medically responsible followed by radiotherapy dose of 60 Gy, which is aimed at the area with a safety margin. The long-term efficacy of additional chemotherapy has been a subject for controversy for several decades. The combination of all three treatment modalities in grade III tumors can lead to median survival times of 3-5 years in adults.

For this treatment group reports of 5 year recurrence free periods in 33-50% of cases have been reported in children and adolescents.

For glioblastoma(WHO grade IV) 5year recurrence free periods are 3% in elderly patients and 10-20% for adolescents.(Schlegel 2003) In German speaking territories chemotherapy with Cisplatin, Etoposid and Ifosfamid is used as a postoperative treatment option for adolescents and this disease.(Wolff HIT-GBM) In case of recurrence therapy choices are even more limited, thus if medically feasible the enrolment in clinical trials is an option.

In this study the aim is to use an antibody directed against the EGF-receptor to effect the proliferation of the tumor cells negatively. Pilot studies conducted in adults indicate that the median survival time for patients with malignant glioma can be prolonged by the antibody treatment.

Eligibility

Ages Eligible for Study:	3 Years to 20 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No
Sampling Method:	Non-Probability Sample

Study Population

children, adolescents

Criteria

Inclusion Criteria:

Histologically confirmed diagnosis of high grade glioma (WHO III und IV) [not needed for intrinsic pontine glioma]
Progressive patients under primary therapy or first and second radiologically confirmed recurrence(MRI not older than 2 weeks) of high grade gliomas between the age of > 3 years < 20 years
Lack of curative standard therapy which is currently under investigation in a national GPOH-therapy optimization study
Sufficient haematological, renal and hepatic function (CTC Grad ≤ 2)
Disease measurable radiologicaly in at least one dimension
Life expectancy > 4 Weeks
Written declaration of consent of the parents/legal guardians and if possible of the child after prior information

Exclusion Criteria:

Curative therapy with an alternative method after diagnosis of progression and during this study
Prior administration of human or murine antibody
Pregnancy in girls of child-bearing age

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00561873

Locations

Germany
University Bonn, Children`s Medical Hospital
Bonn, Germany, 53113

Sponsors and Collaborators

Oncoscience AG

Children`s Medical Hospital, University of Bonn, Germany

University of Wuerzburg

Dept. of Statistics, University of Dortmund, Germany

CRM Biometrics GmbH, Rheinbach, Germany

Heinrich-Heine University, Duesseldorf

Hospital for Children and Adolescents, Augsburg, Germany

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 Essen, Essen, Germany

Dept. of Neuropediatrics and Muscle Disorders, University of Freiburg, Germany

University of Cologne

Universitätsklinikum Hamburg-Eppendorf

Krankenhaus der Barmherzigen Brüder, Klinik St. Hedwig, University of Regensburg,Germany

Investigators

Principal Investigator:

Udo Bode, Prof. MD

University Bonn

More Information

Related Info This link exits the ClinicalTrials.gov site

Study ID Numbers:	BN001-PED04
Study First Received:	November 20, 2007
Last Updated:	November 20, 2007
ClinicalTrials.gov Identifier:	NCT00561873
Health Authority:	Germany: Paul-Ehrlich-Institute

Keywords provided by Oncoscience AG:

astrocytoma, glioblastoma, intrinsic pontine glioma

Study placed in the following topic categories:

Neuroectodermal Tumors
Glioblastoma
Astrocytoma
Neoplasms, Germ Cell and Embryonal

Neuroepithelioma
Glioma
Recurrence
Neoplasms, Glandular and Epithelial

Additional relevant MeSH terms:

Neoplasms
Neoplasms by Histologic Type
Neoplasms, Nerve Tissue
Neoplasms, Neuroepithelial

ClinicalTrials.gov processed this record on January 15, 2009