Nimotuzumab in Children With Intrinsic Pontine Glioma

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 conditions
• 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