Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE3
150 participants
INTERVENTIONAL
2007-08-31
2012-01-31
Brief Summary
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Detailed Description
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Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Arm B
adults with TMZ, RT
nimotuzumab
monoclonal antibody
Arm A
adults with TMZ, RT, nimotuzumab
nimotuzumab
monoclonal antibody
Interventions
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nimotuzumab
monoclonal antibody
Eligibility Criteria
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Inclusion Criteria
* Newly diagnosed, histologically confirmed glioblastoma multiforme grade IV
* Condition is measurable by MRI in at least one dimension
* Age 18-70
* Karnofsky-Index \> 40
* Treatment in a study center
* Female patients with a childbearing potential must have a negative pregnancy test within one week before inclusion in the trial. Those female and male patients admitted in the study must use a reliable method of contraception.
* Adequate haematological, renal and hepatic function:
* Leucocytes \>2.0x10\^9/l
* Hb\> 10g/dl
* Billirubin total \< 2.5x upper limit of normal (ULN)
* Creatinin i.S. \< 1.5x ULN
* AST (GOT)/ALT (GPT) \< 5x ULN
Exclusion Criteria
* Patients with evidence second malignancy
* Patients who are pregnant or patients who refused adequate contraceptive precaution (female and male) during the trial
* Pregnancy and lactation
* Other conditions considered by investigators as sound reasons for disqualification from enrolment into the study such as: potential non compliance with protocol requirement
* No MRI for tumour evaluation
18 Years
70 Years
ALL
No
Sponsors
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Neurological Clinic, Knappschaftskrankenhaus Bochum-Langendreer, Bochum, Germany
UNKNOWN
University of Bonn
OTHER
Dep. of Neurosurgery and Policlinic, University Hospital, Dresden, Germany
OTHER
Heinrich-Heine University, Duesseldorf
OTHER
Johann Wolfgang Goethe University Hospital
OTHER
University of Giessen
OTHER
Universitätsklinikum Hamburg-Eppendorf
OTHER
University of Kiel
OTHER
Dr. von Haunersches Children's Medical Hospital, University of Munich, Germany
OTHER
Universität Tübingen
OTHER
Oncoscience AG
INDUSTRY
Principal Investigators
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Manfred Westphal, Prof. MD
Role: PRINCIPAL_INVESTIGATOR
University Hamburg
Locations
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Dep. Neurosurgery, Univ. Hamburg
Hamburg, , Germany
Countries
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Other Identifiers
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OSAG101-BSA05
Identifier Type: -
Identifier Source: org_study_id