Nimotuzumab in Adults With Glioblastoma Multiforma

This study has been completed.
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 Hospitals
University of Giessen
Universitätsklinikum Hamburg-Eppendorf
University of Kiel
Dr. von Haunersches Children's Medical Hospital, University of Munich, Germany
Neurological Clinic of the University of Tübingen, Tübingen, Germany
Information provided by:
Oncoscience AG
ClinicalTrials.gov Identifier:
NCT00753246
First received: November 20, 2007
Last updated: November 30, 2012
Last verified: November 2012
  Purpose

Determination of efficiency of nimotuzumab in adults with glioblastoma multiforma


Condition Intervention Phase
Adults With Glioblastoma Multiforma
Drug: nimotuzumab
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: 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

Resource links provided by NLM:


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
Study Completion Date: January 2012
Arms Assigned Interventions
Placebo Comparator: Arm B
adults with TMZ, RT
Drug: nimotuzumab
monoclonal antibody
Experimental: Arm A
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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 Hospitals
University of Giessen
Universitätsklinikum Hamburg-Eppendorf
University of Kiel
Dr. von Haunersches Children's Medical Hospital, University of Munich, Germany
Neurological Clinic of the University of Tübingen, Tübingen, Germany
Investigators
Principal Investigator: Manfred Westphal, Prof. MD University Hamburg
  More Information

No publications provided

Responsible Party: Oncoscience AG
ClinicalTrials.gov Identifier: NCT00753246     History of Changes
Other Study ID Numbers: OSAG101-BSA05
Study First Received: November 20, 2007
Last Updated: November 30, 2012
Health Authority: Germany: Paul-Ehrlich-Institut

Keywords provided by Oncoscience AG:
glioblastoma multiforma

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

ClinicalTrials.gov processed this record on October 22, 2014