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

3 Years
20 Years
Not Enrolling
High Grade Glioma

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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

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

Type of Study:


Study Design:

Observational Model: Case-Only, Time Perspective: Prospective

Outcome Measure:

Response rate according to RECIST criteria

Outcome Time Frame:

week 8, week 21

Principal Investigator

Udo Bode, Prof. MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

University Bonn


Germany: Paul-Ehrlich-Institute

Study ID:




Start Date:

June 2004

Completion Date:

February 2007

Related Keywords:

  • High Grade Glioma
  • astrocytoma, glioblastoma, intrinsic pontine glioma
  • Glioma