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Nimotuzumab in Children With Intrinsic Pontine Glioma

This study has been completed.
Sponsor:
Collaborators:
Children`s Medical Hospital, University of Bonn, Germany
University of Wuerzburg
Dept. of Statistics, University of Dortmund, Germany
CRM Biometrics GmbH, Rheinbach, Germany
Heinrich-Heine University, Duesseldorf
Dr. von Haunersches Children's Medical Hospital, University of Munich, Germany
Children`s Medical Hospital, University of Homburg/Saar, Homburg/Saar, Germany
Children`s Medical Hospital, Medical School Hannover, Hannover, Germany
Children`s Medical Hospital, University of Leipzig, Leipzig, Germany
Children`s Medical Hospital, University of Muenster, Muenster, Germany
Burdenko Neurosurgical Institute
Istituto Nazinonale Tumori, Div. of Paediatric Oncology,Milano, Italy
Information provided by (Responsible Party):
Oncoscience AG
ClinicalTrials.gov Identifier:
NCT00561691
First received: November 20, 2007
Last updated: March 27, 2013
Last verified: March 2013
  Purpose

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


Condition Intervention
Diffuse Instrinsic Ponitine Glioma
Drug: nimotuzumab

Study Type: Observational
Study Design: Observational Model: Case-Only
Time Perspective: Prospective
Official Title: Phase III Study on the Effectiveness of OSAG 101 (Theraloc®)in Newly Diagnosed Intrinsic Pontine Gliomas of Children and Adolescents

Resource links provided by NLM:


Further study details as provided by Oncoscience AG:

Primary Outcome Measures:
  • To determine the progression-free survival (PFS) of the combination of monoclonal anti-EGFR antibody OSAG 101 and standard local radiotherapy [ Time Frame: week 12, 24, 36 ]

Secondary Outcome Measures:
  • 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 [ Time Frame: week 12, 24, 36 ]

Enrollment: 41
Study Start Date: April 2006
Study Completion Date: January 2012
Intervention Details:
    Drug: nimotuzumab
    monoclonal antibody
    Other Name: Theraloc
Detailed Description:

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.

  Eligibility

Ages Eligible for Study:   3 Years to 20 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

children and adolescents

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00561691

Locations
Germany
University Bonn, Children`s Medical Hospital
Bonn, Germany, 53113
Sponsors and Collaborators
Oncoscience AG
Children`s Medical Hospital, University of Bonn, Germany
University of Wuerzburg
Dept. of Statistics, University of Dortmund, Germany
CRM Biometrics GmbH, Rheinbach, Germany
Heinrich-Heine University, Duesseldorf
Dr. von Haunersches Children's Medical Hospital, University of Munich, Germany
Children`s Medical Hospital, University of Homburg/Saar, Homburg/Saar, Germany
Children`s Medical Hospital, Medical School Hannover, Hannover, Germany
Children`s Medical Hospital, University of Leipzig, Leipzig, Germany
Children`s Medical Hospital, University of Muenster, Muenster, Germany
Burdenko Neurosurgical Institute
Istituto Nazinonale Tumori, Div. of Paediatric Oncology,Milano, Italy
Investigators
Principal Investigator: Udo Bode, Prof. MD University Bonn
  More Information

Additional Information:
No publications provided

Responsible Party: Oncoscience AG
ClinicalTrials.gov Identifier: NCT00561691     History of Changes
Other Study ID Numbers: OSAG101-BSC05
Study First Received: November 20, 2007
Last Updated: March 27, 2013
Health Authority: Germany: Paul-Ehrlich-Institut

Keywords provided by Oncoscience AG:
diffuse instrinsic ponitine glioma, brainstem

Additional relevant MeSH terms:
Glioma
Neoplasms
Neoplasms by Histologic Type
Neoplasms, Germ Cell and Embryonal
Neoplasms, Glandular and Epithelial
Neoplasms, Nerve Tissue
Neoplasms, Neuroepithelial
Neuroectodermal Tumors

ClinicalTrials.gov processed this record on November 25, 2014