Clinical trial NCT00753246: 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
Overall status: COMPLETED
Phase: PHASE3
Conditions: Adults With Glioblastoma Multiforma
Keywords: glioblastoma multiforma
Lead sponsor: Oncoscience AG
Sponsor class: INDUSTRY
Collaborators: name: Neurological Clinic, Knappschaftskrankenhaus Bochum-Langendreer, Bochum, Germany
name: University of Bonn
name: Dep. of Neurosurgery and Policlinic, University Hospital, Dresden, Germany
name: Heinrich-Heine University, Duesseldorf
name: Johann Wolfgang Goethe University Hospital
name: University of Giessen
name: Universitätsklinikum Hamburg-Eppendorf
name: University of Kiel
name: Dr. von Haunersches Children's Medical Hospital, University of Munich, Germany
name: Universität Tübingen
First posted: 2008-09-16
Enrollment: 150
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: Progression-free interval determined by MRI
timeFrame: week 12, 24, 36, 52
Secondary outcomes:
measure: Overall survival Time to reintervention Response rate according to RECIST criteria Toxicity according to CTC criteria Symptom control Quality of life
timeFrame: week 12, 24, 36, 52
Other outcomes:
Locations:
city: Hamburg
country: Germany
facility: Dep. Neurosurgery, Univ. Hamburg
Study officials:
affiliation: University Hamburg
name: Manfred Westphal, Prof. MD
role: PRINCIPAL_INVESTIGATOR
References: