Status:
COMPLETED
Nimotuzumab in Adults With Glioblastoma Multiforma
Lead Sponsor:
Oncoscience AG
Collaborating Sponsors:
Neurological Clinic, Knappschaftskrankenhaus Bochum-Langendreer, Bochum, Germany
University of Bonn
Conditions:
Adults With Glioblastoma Multiforma
Eligibility:
All Genders
18-70 years
Phase:
PHASE3
Brief Summary
Determination of efficiency of nimotuzumab in adults with glioblastoma multiforma
Detailed Description
The objective of the present study is a comparison of treatment of patients with newly diagnosed glioblastoma multiforme grade IV. Patients will be randomized in one of two arms when included. Patient...
Eligibility Criteria
Inclusion
- Patient signed informed consent
- 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
- Patients with history of anaphylactic reaction to murine or humanized antibody
- 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
Key Trial Info
Start Date :
August 1 2007
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
January 1 2012
Estimated Enrollment :
150 Patients enrolled
Trial Details
Trial ID
NCT00753246
Start Date
August 1 2007
End Date
January 1 2012
Last Update
December 3 2012
Active Locations (1)
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1
Dep. Neurosurgery, Univ. Hamburg
Hamburg, Germany, 20246