Nimotuzumab in Children With Intrinsic Pontine Glioma

NCT00561691 | Completed DMC

• 1 other identifier: OSAG101-BSC05
• Study Type: observational
• Target: 41
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Diffuse Instrinsic Ponitine Glioma

Keywords

diffuse instrinsic ponitine glioma, brainstem

Outcome Measures

Primary Outcomes (1)

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

  week 12, 24, 36

Secondary Outcomes (1)

• To determine the objective response rate (R=CR+PR+SD/Nr) according to RECIST To determine the duration of response and the overall survival To assess adverse events and the toxicity profile according to CTCAE version 3.0

  week 12, 24, 36

Interventions

nimotuzumab DRUG

monoclonal antibody

Also known as: Theraloc

Eligibility Criteria

• Age: 3 Years - 20 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)
• Sampling Method: Non-Probability Sample

Study Population

children and adolescents

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

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

Study Sites (1)

University Bonn, Children's Medical Hospital

Bonn, 53113, Germany

Location

Related Links

• Related Info

MeSH Terms

Interventions

nimotuzumab

Study Officials

• Udo Bode, Prof. MD

  University Bonn

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 20, 2007
• First Posted: November 21, 2007
• Study Start: April 1, 2006
• Study Completion: January 1, 2012
• Last Updated: March 29, 2013

Record last verified: 2013-03

Locations

DE (1)