Nimotuzumab in Children With HGG

High Grade Glioma Clinical Trial

Official title:

Phase-II-Study of Efficacy of OSAG 101 (Theraloc®) for Adolscent Patients With Recurrent High Grade Glioma

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00561873
• Other study ID #: BN001-PED04
• Status: Completed
• Phase: N/A
• First received: November 20, 2007
• Last updated: November 20, 2007
• Start date: June 2004
• Est. completion date: February 2007

Study information

• Verified date: November 2007
• Source: Oncoscience AG
• Contact: n/a
• Is FDA regulated: No
• Health authority: Germany: Paul-Ehrlich-Institute
• Study type: Observational

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 45
• Est. completion date: February 2007
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 3 Years to 20 Years

Eligibility

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

Study Design

Observational Model: Case-Only, Time Perspective: Prospective

Related Conditions & MeSH terms

• Glioma
• High Grade Glioma

Locations

Country	Name	City	State
Germany	University Bonn, Children`s Medical Hospital	Bonn

Sponsors (16)

Lead Sponsor

Collaborator

Oncoscience AG

Children's Medical Hospital, University of Essen, Essen, Germany, Children`s Medical Hospital, University of Bonn, Germany, Children`s Medical Hospital, University of Homburg/Saar, Homburg/Saar, Germany, CRM Biometrics GmbH, Dept. of Neuropediatrics and Muscle Disorders, University of Freiburg, Germany, Dept. of Statistics, University of Dortmund, Germany, Dr. von Haunersches Children's Medical Hospital, University of Munich, Germany, Hannover Medical School, Heinrich-Heine University, Duesseldorf, Klinikum Augsburg, Universitätsklinikum Hamburg-Eppendorf, University of Bonn, University of Cologne, University of Regensburg, University of Wuerzburg

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Response rate according to RECIST criteria		week 8, week 21
Secondary	Progress free interval, Toxicity according to CTC criteria, Symptom control		week 8, week 21

External Links

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