Nimotuzumab in Children With Intrinsic Pontine Glioma

• Status: Completed
• Trial end date: 2012-01-01
• Target enrollment: 0
• Participant gender: All

Summary

Determination of efficiency of nimotuzumab in children with diffuse intrinsic pontine glioma.

• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Oncoscience AG
• Collaborators: Burdenko Neurosurgery Institute; Children`s Medical Hospital, University of Bonn, Germany; Children`s Medical Hospital, University of Homburg/Saar, Homburg/Saar, Germany; Children`s Medical Hospital, University of Leipzig, Leipzig, Germany; Children`s Medical Hospital, University of Muenster, Muenster, Germany; Children's Medical Hospital, Medical School Hannover, Hannover, Germany; Children's Medical Hospital, University of Bonn, Germany; Children's Medical Hospital, University of Homburg/Saar, Homburg/Saar, Germany; Children's Medical Hospital, University of Leipzig, Leipzig, Germany; Children's Medical Hospital, University of Muenster, Muenster, Germany; CRM Biometrics GmbH; Dept. of Statistics, University of Dortmund, Germany; Dr. von Haunersches Children's Medical Hospital, University of Munich, Germany; Hannover Medical School; Heinrich-Heine University, Duesseldorf; Istituto Nazinonale Tumori, Div. of Paediatric Oncology,Milano, Italy; University of Wuerzburg
• Treatments: Nimotuzumab

Criteria

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 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