Nimotuzumab in Adults With Glioblastoma Multiforma

November 30, 2012 updated by: Oncoscience AG

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

Determination of efficiency of nimotuzumab in adults with glioblastoma multiforma

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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

Interventional

Enrollment (Anticipated)

150

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Germany
      • Hamburg, Germany, 20246
        • Dep. Neurosurgery, Univ. Hamburg

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 70 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: NONE

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

Outcome Measure
Time Frame
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
week 12, 24, 36, 52

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Oncoscience AG

Collaborators

Heinrich-Heine University, Duesseldorf
University of Kiel
Johann Wolfgang Goethe University Hospital
University of Giessen
Universitätsklinikum Hamburg-Eppendorf
Dr. von Haunersches Children's Medical Hospital, University of Munich, Germany
Universität Tübingen
University of Bonn
Neurological Clinic, Knappschaftskrankenhaus Bochum-Langendreer, Bochum, Germany
Dep. of Neurosurgery and Policlinic, University Hospital, Dresden, Germany

Investigators

  • Principal Investigator: Manfred Westphal, Prof. MD, University Hamburg

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

August 1, 2007

Study Completion (ACTUAL)

January 1, 2012

Study Registration Dates

First Submitted

November 20, 2007

First Submitted That Met QC Criteria

September 15, 2008

First Posted (ESTIMATE)

September 16, 2008

Study Record Updates

Last Update Posted (ESTIMATE)

December 3, 2012

Last Update Submitted That Met QC Criteria

November 30, 2012

Last Verified

November 1, 2012

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • OSAG101-BSA05

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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