Nimotuzumab in Adults With Glioblastoma Multiforma

• Register: ClinicalTrials.gov
• Last refreshed on: 19 February 2015
• Main ID: NCT00753246
• Date of registration: 20/11/2007
• Prospective Registration: No
• Primary sponsor: Oncoscience AG
• Public title: Nimotuzumab in Adults With Glioblastoma Multiforma
• Scientific 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
• Date of first enrolment: August 2007
• Target sample size: 150
• Recruitment status: Completed
• URL: http://clinicaltrials.gov/show/NCT00753246
• Study type: Interventional
• Study design: Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
• Phase: Phase 3

Countries of recruitment

Germany

Contacts

• Name: Manfred Westphal, Prof. MD
• Affiliation: University Hamburg

Key inclusion & exclusion 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



Age minimum: 18 Years
Age maximum: 70 Years
Gender: Both

Health Condition(s) or Problem(s) studied

Adults With Glioblastoma Multiforma

Intervention(s)

Drug: nimotuzumab

Primary Outcome(s)

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

Secondary Outcome(s)

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]

Secondary ID(s)

OSAG101-BSA05

Source(s) of Monetary Support

Please refer to primary and secondary sponsors

Secondary Sponsor(s)

Dr. von Haunersches Children's Medical Hospital, University of Munich, Germany

Dep. of Neurosurgery and Policlinic, University Hospital, Dresden, Germany

Neurological Clinic, Knappschaftskrankenhaus Bochum-Langendreer, Bochum, Germany

University of Giessen

Universitätsklinikum Hamburg-Eppendorf

University of Bonn

Heinrich-Heine University, Duesseldorf

Johann Wolfgang Goethe University Hospitals

Neurological Clinic of the University of Tübingen, Tübingen, Germany

University of Kiel