Nimotuzumab in Children With HGG

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

45 participants

Study Classification

OBSERVATIONAL

Study Start Date

2004-06-30

Study Completion Date

2007-02-28

Brief Summary

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

Detailed Description

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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.

Conditions

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High Grade Glioma

Keywords

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astrocytoma, glioblastoma, intrinsic pontine glioma

Study Design

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Observational Model Type

CASE_ONLY

Study Time Perspective

PROSPECTIVE

Eligibility Criteria

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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

Minimum Eligible Age

3 Years

Maximum Eligible Age

20 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Principal Investigators

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Udo Bode, Prof. MD

Role: PRINCIPAL_INVESTIGATOR

University Bonn

Locations

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University Bonn, Children's Medical Hospital

Bonn, , Germany

Site Status

Countries

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Germany

Other Identifiers

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BN001-PED04

Identifier Type: -

Identifier Source: org_study_id

Nimotuzumab in Children With HGG

Study Results

Basic Information

Brief Summary

Detailed Description

Conditions

Keywords

Study Design

Eligibility Criteria

Inclusion Criteria

Exclusion Criteria

Sponsors

Children's Medical Hospital, University of Bonn, Germany

University of Wuerzburg

University of Bonn

Dept. of Statistics, University of Dortmund, Germany

CRM Biometrics GmbH

Heinrich-Heine University, Duesseldorf

University Hospital Augsburg

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

University of Regensburg

Oncoscience AG