Clinical trial NCT00561873: Nimotuzumab in Children With HGG
Official title: Phase-II-Study of Efficacy of OSAG 101 (Theraloc®) for Adolscent Patients With Recurrent High Grade Glioma
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: High Grade Glioma
Keywords: astrocytoma, glioblastoma, intrinsic pontine glioma
Lead sponsor: Oncoscience AG
Sponsor class: INDUSTRY
Collaborators: name: Children's Medical Hospital, University of Bonn, Germany
name: University of Wuerzburg
name: University of Bonn
name: Dept. of Statistics, University of Dortmund, Germany
name: CRM Biometrics GmbH
name: Heinrich-Heine University, Duesseldorf
name: University Hospital Augsburg
name: Dr. von Haunersches Children's Medical Hospital, University of Munich, Germany
name: Children's Medical Hospital, University of Homburg/Saar, Homburg/Saar, Germany
name: Children's Medical Hospital, Medical School Hannover, Hannover, Germany
name: Children's Medical Hospital, University of Essen, Essen, Germany
name: Dept. of Neuropediatrics and Muscle Disorders, University of Freiburg, Germany
name: University of Cologne
name: Universitätsklinikum Hamburg-Eppendorf
name: University of Regensburg
First posted: 2007-11-21
Enrollment: 45
Sex: ALL
Minimum age (years): 3
Maximum age (years): 20
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: children, adolescents

Brief summary: Determination of efficiency of nimotuzumab in children with high grade glioma.

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 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

Primary outcomes:
measure: Response rate according to RECIST criteria
timeFrame: week 8, week 21
Secondary outcomes:
measure: Progress free interval, Toxicity according to CTC criteria, Symptom control
timeFrame: week 8, week 21
Other outcomes:
Locations:
city: Bonn
country: Germany
facility: University Bonn, Children's Medical Hospital
Study officials:
affiliation: University Bonn
name: Udo Bode, Prof. MD
role: PRINCIPAL_INVESTIGATOR
References: