Trial Information

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

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.