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Phase III Study on the Effectiveness of OSAG 101 (Theraloc®)in Newly Diagnosed Intrinsic Pontine Gliomas of Children and Adolescents

3 Years
20 Years
Not Enrolling
Diffuse Instrinsic Ponitine Glioma

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Trial Information

Phase III Study on the Effectiveness of OSAG 101 (Theraloc®)in Newly Diagnosed Intrinsic Pontine Gliomas of Children and Adolescents

Due to the poor prognosis of diffuse intrinsic pontine gliomas, the limited therapy options,
the relevant portion of EGFR expression and the unexpected good response to the therapy with
OSAG 101 in the phase II study, a phase III study was planned in newly diagnosed diffuse
intrinsic pontine gliomas in children and adolescents. A phase II study in patients of
recurrence/resistance high grade glioma in childhood or adolescence showed that, in
particular, a part of the intrinsic pontine glioma response to the monotherapy with OSAG 101
resulting in a reduction in the size of the tumour or stabilisation in the growth of the
tumour. Together with clinical improvement, stabilisation lasted markedly over 6 months in
two thirds of the patients. The current phase III study was scheduled to provide evidence of
the effectiveness in the case of newly diagnosed intrinsic pontine glioma. In this study,
OSAG 101 will be given concomitantly to the only standard therapy for this kind of tumour,
i.e. the fractionated radiotherapy, to show effectiveness in the primary endpoint of median
progression-free survival, the secondary endpoint of median overall survival and the side
effect profile.

Evidence from the median progression-free survival and the side effect profile of this
combination met the expected results and one may consider that combination therapy of this
therapeutic approach with other immunotherapeutic or antiangiogenic approaches and/or mild
chemotherapy could lead to a better prognosis and quality of life for these patients.

Inclusion Criteria:

Histology and staging of disease:

- Newly diagnosed intrinsic pontine glioma documented by MRI and measurable in at least
one dimension

- Histology is not required for this study, tumour biopsy is not recommended General

- Age ≥ 3 years to ≤ 20 years, both gender

- Life expectancy ≥ 4 weeks

- Performance status ECOG ≥ 3 or Karnofsky/Lansky status ≥ 40%

- Adequate haematological, renal, and hepatic function Absolute leukocyte count ≥ 2.0 x
109/l Haemoglobin ≥ 10 g/dl Platelets ≥ 50 x 109/l Bilirubin total ≤ 2.5 x ULN
ALT/AST ≤ 5.0 x ULN Creatinine i. S. ≤ 1.5 x ULN

Prior/initial examinations (within 14 days prior to the start of therapy):

- Cranial MRI (estimation of index lesion)

- Clinical internal and neurological examination; body weight, height, surface,
Performance status by ECOG, Karnofsky or Lansky

- Blood cell count, blood gas analysis; serum analysis for electrolytes (Na, K, Ca,
Mg), chloride, phosphate, creatinine, BUN, AST, ALT, bilirubin, GGT, LDH, lipase,
total protein, CRP, blood sugar; coagulation test (Quick, PTT, TT); urinalysis

- EKG, echocardiography in case of positive cardiac history

- Pregnancy test in females of childbearing age Other criteria

- Planned day of first antibody application within 14 days after MRI

- Written and signed informed consent from patient and/or parents or legal
guardian(s)(s) after being informed

- Negative pregnancy test in females of childbearing age

- Treatment in a study centre

- Availability of the patient during the study treatment and the ability to comply with
the study plan

Exclusion Criteria:

- Pontine glioma as secondary malignancy

- Low grade brain stem glioma (i.e. focal, cervicomedullar, tectal brain stem glioma)

- Other severe underlying disease or pre-existing serious conditions which bear the
risk of an inadequate study treatment (e.g. severe mental retardation, severe
statomotoric retardation, severe cerebral palsy, congenital syndromes)

- Prior antineoplastic therapy, inclusively chemotherapy, immunotherapy, radiotherapy

- Prior administration of a recombinant human or mural antibody or known
hypersensitivity to antibodies

- Simultaneous antineoplastic therapy other than the study treatment

- Participation in another therapeutic study or experimental treatment involving the
underlying cancer disease

- Pregnancy, lactating mother and inadequate contraception in females and males of
childbearing age

Type of Study:


Study Design:

Observational Model: Case-Only, Time Perspective: Prospective

Outcome Measure:

To determine the progression-free survival (PFS) of the combination of monoclonal anti-EGFR antibody OSAG 101 and standard local radiotherapy

Outcome Time Frame:

week 12, 24, 36

Principal Investigator

Udo Bode, Prof. MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

University Bonn


Germany: Paul-Ehrlich-Institut

Study ID:




Start Date:

April 2006

Completion Date:

January 2012

Related Keywords:

  • Diffuse Instrinsic Ponitine Glioma
  • diffuse instrinsic ponitine glioma, brainstem
  • Glioma
  • Pontine Glioma