Nimotuzumab in Children With HGG
Phase-II-Study of Efficacy of OSAG 101 (Theraloc®) for Adolscent Patients With Recurrent High Grade Glioma
1 other identifier
observational
45
1 country
1
Brief Summary
Determination of efficiency of nimotuzumab in children with high grade glioma.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for all trials
Started Jun 2004
Typical duration for all trials
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
June 1, 2004
CompletedStudy Completion
Last participant's last visit for all outcomes
February 1, 2007
CompletedFirst Submitted
Initial submission to the registry
November 20, 2007
CompletedFirst Posted
Study publicly available on registry
November 21, 2007
CompletedNovember 21, 2007
November 1, 2007
November 20, 2007
November 20, 2007
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Response rate according to RECIST criteria
week 8, week 21
Secondary Outcomes (1)
Progress free interval, Toxicity according to CTC criteria, Symptom control
week 8, week 21
Eligibility Criteria
children, adolescents
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Oncoscience AGlead
- Children's Medical Hospital, University of Bonn, Germanycollaborator
- University of Wuerzburgcollaborator
- University of Bonncollaborator
- Dept. of Statistics, University of Dortmund, Germanycollaborator
- CRM Biometrics GmbHcollaborator
- Heinrich-Heine University, Duesseldorfcollaborator
- University Hospital Augsburgcollaborator
- Dr. von Haunersches Children's Medical Hospital, University of Munich, Germanycollaborator
- Children's Medical Hospital, University of Homburg/Saar, Homburg/Saar, Germanycollaborator
- Children's Medical Hospital, Medical School Hannover, Hannover, Germanycollaborator
- Children's Medical Hospital, University of Essen, Essen, Germanycollaborator
- Dept. of Neuropediatrics and Muscle Disorders, University of Freiburg, Germanycollaborator
- University of Colognecollaborator
- Universitätsklinikum Hamburg-Eppendorfcollaborator
- University of Regensburgcollaborator
Study Sites (1)
University Bonn, Children's Medical Hospital
Bonn, 53113, Germany
Related Links
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Udo Bode, Prof. MD
University Bonn
Study Design
- Study Type
- observational
- Observational Model
- CASE ONLY
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- INDUSTRY
Study Record Dates
First Submitted
November 20, 2007
First Posted
November 21, 2007
Study Start
June 1, 2004
Study Completion
February 1, 2007
Last Updated
November 21, 2007
Record last verified: 2007-11