Nimotuzumab in Adults With Glioblastoma Multiforma

• Status: Completed
• Trial end date: 2012-01-01
• Target enrollment: 0
• Participant gender: All

Summary

Determination of efficiency of nimotuzumab in adults with glioblastoma multiforma

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Oncoscience AG
• Collaborators: Dep. of Neurosurgery and Policlinic, University Hospital, Dresden, Germany; Dr. von Haunersches Children's Medical Hospital, University of Munich, Germany; Heinrich-Heine University, Duesseldorf; Johann Wolfgang Goethe University Hospital; Neurological Clinic of the University of Tübingen, Tübingen, Germany; Neurological Clinic, Knappschaftskrankenhaus Bochum-Langendreer, Bochum, Germany; Universität Tübingen; Universitätsklinikum Hamburg-Eppendorf; University of Bonn; University of Giessen; University of Kiel
• Treatments: Nimotuzumab

Criteria

Inclusion Criteria:

• 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 Criteria:

• 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