Nimotuzumab in Children With HGG

Launched by ONCOSCIENCE AG · Nov 20, 2007

Keywords

ClinConnect Summary

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 ...

Gender

ALL

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