Working...
ClinicalTrials.gov
ClinicalTrials.gov Menu

Nimotuzumab in Adults With Glioblastoma Multiforma

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT00753246
Recruitment Status : Completed
First Posted : September 16, 2008
Last Update Posted : December 3, 2012
Sponsor:
Collaborators:
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
Information provided by:
Oncoscience AG

Tracking Information
First Submitted Date  ICMJE November 20, 2007
First Posted Date  ICMJE September 16, 2008
Last Update Posted Date December 3, 2012
Study Start Date  ICMJE August 2007
Primary Completion Date Not Provided
Current Primary Outcome Measures  ICMJE
 (submitted: September 15, 2008)
Progression-free interval determined by MRI [ Time Frame: week 12, 24, 36, 52 ]
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT00753246 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: September 15, 2008)
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 ]
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Nimotuzumab in Adults With Glioblastoma Multiforma
Official Title  ICMJE 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
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. 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 Type  ICMJE Interventional
Study Phase  ICMJE Phase 3
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Adults With Glioblastoma Multiforma
Intervention  ICMJE Drug: nimotuzumab
monoclonal antibody
Study Arms  ICMJE
  • Placebo Comparator: Arm B
    adults with TMZ, RT
    Intervention: Drug: nimotuzumab
  • Experimental: Arm A
    adults with TMZ, RT, nimotuzumab
    Intervention: Drug: nimotuzumab
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Estimated Enrollment  ICMJE
 (submitted: September 15, 2008)
150
Original Estimated Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE January 2012
Primary Completion Date Not Provided
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 70 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Germany
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00753246
Other Study ID Numbers  ICMJE OSAG101-BSA05
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Oncoscience AG
Study Sponsor  ICMJE Oncoscience AG
Collaborators  ICMJE
  • 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  ICMJE
Principal Investigator: Manfred Westphal, Prof. MD University Hamburg
PRS Account Oncoscience AG
Verification Date November 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP