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Nimotuzumab in Children With HGG

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ClinicalTrials.gov Identifier: NCT00561873
Recruitment Status : Completed
First Posted : November 21, 2007
Last Update Posted : November 21, 2007
Information provided by:

Study Description
Brief Summary:
Determination of efficiency of nimotuzumab in children with high grade glioma.

Condition or disease
High Grade Glioma

Detailed Description:

High grade malignant gliomas are tumors grade III and IV according to WHO classification, that originate from oligodendroglia and astrocytes, where the latter are also known as anaplastic astrocytoma(WHO grade III) and glioblastoma(WHO grade IV). This also includes intrinsic pontine gliomas of adolescents, which are usually not documented histologically due to their localisation, but they have a similar clinical progress when compared to high grade malignant astrocytic tumors. Among various molecular alterations, malignant gliomas overexpress EGFR (epidermal growth factor) in nearly 50% of cases, which is particularly pronounced in glioblastoma.(Schlegel 2003) Standard therapy consists of radical surgery as extensive as medically responsible followed by radiotherapy dose of 60 Gy, which is aimed at the area with a safety margin. The long-term efficacy of additional chemotherapy has been a subject for controversy for several decades. The combination of all three treatment modalities in grade III tumors can lead to median survival times of 3-5 years in adults.

For this treatment group reports of 5 year recurrence free periods in 33-50% of cases have been reported in children and adolescents.

For glioblastoma(WHO grade IV) 5year recurrence free periods are 3% in elderly patients and 10-20% for adolescents.(Schlegel 2003) In German speaking territories chemotherapy with Cisplatin, Etoposid and Ifosfamid is used as a postoperative treatment option for adolescents and this disease.(Wolff HIT-GBM) In case of recurrence therapy choices are even more limited, thus if medically feasible the enrolment in clinical trials is an option.

In this study the aim is to use an antibody directed against the EGF-receptor to effect the proliferation of the tumor cells negatively. Pilot studies conducted in adults indicate that the median survival time for patients with malignant glioma can be prolonged by the antibody treatment.

Study Design

Study Type : Observational
Actual Enrollment : 45 participants
Observational Model: Case-Only
Time Perspective: Prospective
Official Title: Phase-II-Study of Efficacy of OSAG 101 (Theraloc®) for Adolscent Patients With Recurrent High Grade Glioma
Study Start Date : June 2004
Study Completion Date : February 2007

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Groups and Cohorts

Outcome Measures

Primary Outcome Measures :
  1. Response rate according to RECIST criteria [ Time Frame: week 8, week 21 ]

Secondary Outcome Measures :
  1. Progress free interval, Toxicity according to CTC criteria, Symptom control [ Time Frame: week 8, week 21 ]

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   3 Years to 20 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
children, adolescents

Inclusion Criteria:

  • Histologically confirmed diagnosis of high grade glioma (WHO III und IV) [not needed for intrinsic pontine glioma]
  • Progressive patients under primary therapy or first and second radiologically confirmed recurrence(MRI not older than 2 weeks) of high grade gliomas between the age of > 3 years < 20 years
  • Lack of curative standard therapy which is currently under investigation in a national GPOH-therapy optimization study
  • Sufficient haematological, renal and hepatic function (CTC Grad ≤ 2)
  • Disease measurable radiologicaly in at least one dimension
  • Life expectancy > 4 Weeks
  • Written declaration of consent of the parents/legal guardians and if possible of the child after prior information

Exclusion Criteria:

  • Curative therapy with an alternative method after diagnosis of progression and during this study
  • Prior administration of human or murine antibody
  • Pregnancy in girls of child-bearing age
Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00561873

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
University of Bonn
Dept. of Statistics, University of Dortmund, Germany
CRM Biometrics GmbH
Heinrich-Heine University, Duesseldorf
Klinikum Augsburg
Dr. von Haunersches Children's Medical Hospital, University of Munich, Germany
Children`s Medical Hospital, University of Homburg/Saar, Homburg/Saar, Germany
Hannover Medical School
Children's Medical Hospital, University of Essen, Essen, Germany
Dept. of Neuropediatrics and Muscle Disorders, University of Freiburg, Germany
University of Cologne
Universitätsklinikum Hamburg-Eppendorf
University of Regensburg
Principal Investigator: Udo Bode, Prof. MD University Bonn
More Information

Additional Information:
ClinicalTrials.gov Identifier: NCT00561873     History of Changes
Other Study ID Numbers: BN001-PED04
First Posted: November 21, 2007    Key Record Dates
Last Update Posted: November 21, 2007
Last Verified: November 2007

Keywords provided by Oncoscience AG:
astrocytoma, glioblastoma, intrinsic pontine glioma

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