Trial | NCT00753246  Report issue

Title

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

  • Phase

    Phase 3

  • Study Type

    Interventional

  • Status

    Completed No Results Posted

  • Study Participants

    150
Determination of efficiency of nimotuzumab in adults with glioblastoma multiforma
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 Started
Aug 31
2007
Study Completion
Jan 31
2012
Last Update
Dec 03
2012
Estimate

Drug nimotuzumab

monoclonal antibody

Arm B Placebo Comparator

adults with TMZ, RT

Arm A Experimental

adults with TMZ, RT, nimotuzumab

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
No Results Posted