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

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.

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