Nimotuzumab in Adults With Glioblastoma Multiforma

This study is currently recruiting participants.

Verified by Oncoscience AG, September 2008

Sponsors and Collaborators:	Oncoscience AG Neurological Clinic, Knappschaftskrankenhaus Bochum-Langendreer, Bochum, Germany University of Bonn, Department of Neurosurgery, Bonn, Germany Dep. of Neurosurgery and Policlinic, University Hospital, Dresden, Germany Heinrich-Heine University, Duesseldorf Dep. of Neurosurgery, University Hostpital, Frankfurt am Main, Germany University of Giessen Universitätsklinikum Hamburg-Eppendorf University of Kiel Dep. of Neurosurgery and Policlinic, University Hospital Munich, München, Germany Neurological Clinic of the University of Tübingen, Tübingen, Germany
Information provided by:	Oncoscience AG
ClinicalTrials.gov Identifier:	NCT00753246

Purpose

Determination of efficiency of nimotuzumab in adults with glioblastoma multiforma

Condition	Intervention	Phase
Adults With Glioblastoma Multiforma	Drug: nimotuzumab	Phase III

Drug Information available for: Temozolomide Immunoglobulins Globulin, Immune

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Open Label, Parallel Assignment, Efficacy Study
Official Title:	Phase-III Study of Standard Radiotherapy Plus Concomitant and Adjuvant OSAG 101 (Theraloc®) Plus Temozolomide vs. Standard Radiotherapy Plus Concomitant and Adjuvant Temozolomide in Patient With Newly Diagnosed, Histologically Confirmed Glioblastoma Multiforme Grade IV

Further study details as provided by Oncoscience AG:

Primary Outcome Measures:

Progression-free interval determined by MRI [ Time Frame: week 12, 24, 36, 52 ]

Secondary Outcome Measures:

Overall survival Time to reintervention Response rate according to RECIST criteria Toxicity according to CTC criteria Symptom control Quality of life [ Time Frame: week 12, 24, 36, 52 ]

Estimated Enrollment:	150
Study Start Date:	August 2007
Estimated Study Completion Date:	August 2010

Arms	Assigned Interventions
Arm B: Placebo Comparator adults with TMZ, RT	Drug: nimotuzumab monoclonal antibody
Arm A: Experimental adults with TMZ, RT, nimotuzumab	Drug: nimotuzumab monoclonal antibody

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. Patients randomly assigned to arm A will receive Nimotuzumab (OSAG 101) plus Temozolomide concomitant with standard radiotherapy. Patients randomised in arm B will receive standard radiotherapy plus Temozolomide treatment.

Eligibility

Ages Eligible for Study:	18 Years to 70 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00753246

Contacts

Contact: Oliver Heese, MD	+49 40 42803 - 2752	heese@uke.uni-hamburg.de
Contact: Ferdinand Bach	+49-4103-180880	f.bach@oncoscience-ag.de

Locations

Germany
Dep. Neurosurgery, Univ. Hamburg	Recruiting
Hamburg, Germany, 20246
Contact: Oliver Heese, MD +49 40 42803 - 2752 heese@uke.uni-hamburg.de

Sponsors and Collaborators

Oncoscience AG

Neurological Clinic, Knappschaftskrankenhaus Bochum-Langendreer, Bochum, Germany

University of Bonn, Department of Neurosurgery, Bonn, Germany

Dep. of Neurosurgery and Policlinic, University Hospital, Dresden, Germany

Heinrich-Heine University, Duesseldorf

Dep. of Neurosurgery, University Hostpital, Frankfurt am Main, Germany

University of Giessen

Universitätsklinikum Hamburg-Eppendorf

University of Kiel

Dep. of Neurosurgery and Policlinic, University Hospital Munich, München, Germany

Neurological Clinic of the University of Tübingen, Tübingen, Germany

Investigators

Principal Investigator:

Manfred Westphal, Prof. MD

University Hamburg

More Information

Responsible Party:	( Oncoscience AG )
Study ID Numbers:	OSAG101-BSA05
Study First Received:	November 20, 2007
Last Updated:	September 15, 2008
ClinicalTrials.gov Identifier:	NCT00753246
Health Authority:	Germany: Paul-Ehrlich-Institut

Keywords provided by Oncoscience AG:

glioblastoma multiforma

Study placed in the following topic categories:

Antibodies, Monoclonal
Neuroectodermal Tumors
Glioblastoma
Antibodies
Glioblastoma multiforme
Astrocytoma

Neoplasms, Germ Cell and Embryonal
Neuroepithelioma
Glioma
Temozolomide
Immunoglobulins
Neoplasms, Glandular and Epithelial

Additional relevant MeSH terms:

Neoplasms
Neoplasms by Histologic Type
Neoplasms, Nerve Tissue
Neoplasms, Neuroepithelial

ClinicalTrials.gov processed this record on January 16, 2009