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Nimotuzumab in Adults With Glioblastoma Multiforma

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

Status
Completed
Phases
Phase 3
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT00753246
Enrollment
150
Registered
2008-09-16
Start date
2007-08-31
Completion date
2012-01-31
Last updated
2012-12-03

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Adults With Glioblastoma Multiforma

Keywords

glioblastoma multiforma

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.

Interventions

DRUGnimotuzumab

monoclonal antibody

Sponsors

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

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to 70 Years
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frame
Progression-free interval determined by MRIweek 12, 24, 36, 52

Secondary

MeasureTime frame
Overall survival Time to reintervention Response rate according to RECIST criteria Toxicity according to CTC criteria Symptom control Quality of lifeweek 12, 24, 36, 52

Countries

Germany

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 12, 2026