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Nimotuzumab in Adults With Glioblastoma Multiforma

Primary Purpose

Adults With Glioblastoma Multiforma

Status
Completed
Phase
Phase 3
Locations
Germany
Study Type
Interventional
Intervention
nimotuzumab
Sponsored by
Oncoscience AG
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Adults With Glioblastoma Multiforma focused on measuring glioblastoma multiforma

Eligibility Criteria

18 Years - 70 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Dep. Neurosurgery, Univ. Hamburg

Arms of the Study

Arm 1

Arm 2

Arm Type

Placebo Comparator

Experimental

Arm Label

Arm B

Arm A

Arm Description

adults with TMZ, RT

adults with TMZ, RT, nimotuzumab

Outcomes

Primary Outcome Measures

Progression-free interval determined by MRI

Secondary Outcome Measures

Overall survival Time to reintervention Response rate according to RECIST criteria Toxicity according to CTC criteria Symptom control Quality of life

Full Information

First Posted
November 20, 2007
Last Updated
November 30, 2012
Sponsor
Oncoscience AG
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
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1. Study Identification

Unique Protocol Identification Number
NCT00753246
Brief Title
Nimotuzumab in Adults With Glioblastoma Multiforma
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 Type
Interventional

2. Study Status

Record Verification Date
November 2012
Overall Recruitment Status
Completed
Study Start Date
August 2007 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
January 2012 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
Oncoscience AG
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

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Adults With Glioblastoma Multiforma
Keywords
glioblastoma multiforma

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
150 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Arm B
Arm Type
Placebo Comparator
Arm Description
adults with TMZ, RT
Arm Title
Arm A
Arm Type
Experimental
Arm Description
adults with TMZ, RT, nimotuzumab
Intervention Type
Drug
Intervention Name(s)
nimotuzumab
Intervention Description
monoclonal antibody
Primary Outcome Measure Information:
Title
Progression-free interval determined by MRI
Time Frame
week 12, 24, 36, 52
Secondary Outcome Measure Information:
Title
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

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Manfred Westphal, Prof. MD
Organizational Affiliation
University Hamburg
Official's Role
Principal Investigator
Facility Information:
Facility Name
Dep. Neurosurgery, Univ. Hamburg
City
Hamburg
ZIP/Postal Code
20246
Country
Germany

12. IPD Sharing Statement

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Nimotuzumab in Adults With Glioblastoma Multiforma

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