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Nimotuzumab in Adults With Glioblastoma Multiforma

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ClinicalTrials.gov Identifier: NCT00753246
Recruitment Status : Completed
First Posted : September 16, 2008
Last Update Posted : December 3, 2012
Sponsor:
Collaborators:
Information provided by:

Study Description
Brief Summary:
Determination of efficiency of nimotuzumab in adults with glioblastoma multiforma

Condition or disease Intervention/treatment Phase
Adults With Glioblastoma Multiforma Drug: nimotuzumab Phase 3

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.

Study Design

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 150 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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
Study Start Date : August 2007
Study Completion Date : January 2012

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arms and Interventions

Arm Intervention/treatment
Placebo Comparator: Arm B
adults with TMZ, RT
Drug: nimotuzumab
monoclonal antibody
Experimental: Arm A
adults with TMZ, RT, nimotuzumab
Drug: nimotuzumab
monoclonal antibody


Outcome Measures

Primary Outcome Measures :
  1. Progression-free interval determined by MRI [ Time Frame: week 12, 24, 36, 52 ]

Secondary Outcome Measures :
  1. 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 ]

Eligibility Criteria

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Ages Eligible for Study:   18 Years to 70 Years   (Adult, Senior)
Sexes Eligible for Study:   All
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00753246


Locations
Germany
Dep. Neurosurgery, Univ. Hamburg
Hamburg, Germany, 20246
Sponsors and Collaborators
Oncoscience AG
Neurological Clinic, Knappschaftskrankenhaus Bochum-Langendreer, Bochum, Germany
University of Bonn
Dep. of Neurosurgery and Policlinic, University Hospital, Dresden, Germany
Heinrich-Heine University, Duesseldorf
Johann Wolfgang Goethe University Hospital
University of Giessen
Universitätsklinikum Hamburg-Eppendorf
University of Kiel
Dr. von Haunersches Children's Medical Hospital, University of Munich, Germany
Universität Tübingen
Investigators
Principal Investigator: Manfred Westphal, Prof. MD University Hamburg
More Information

Responsible Party: Oncoscience AG
ClinicalTrials.gov Identifier: NCT00753246     History of Changes
Other Study ID Numbers: OSAG101-BSA05
First Posted: September 16, 2008    Key Record Dates
Last Update Posted: December 3, 2012
Last Verified: November 2012

Keywords provided by Oncoscience AG:
glioblastoma multiforma

Additional relevant MeSH terms:
Glioblastoma
Astrocytoma
Glioma
Neoplasms, Neuroepithelial
Neuroectodermal Tumors
Neoplasms, Germ Cell and Embryonal
Neoplasms by Histologic Type
Neoplasms
Neoplasms, Glandular and Epithelial
Neoplasms, Nerve Tissue