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
18 Years
70 Years
Both
Adults With Glioblastoma Multiforma
Trial Information
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
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
Type of Study:
Interventional
Study Design:
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Outcome Measure:
Progression-free interval determined by MRI
Outcome Time Frame:
week 12, 24, 36, 52
Principal Investigator
Manfred Westphal, Prof. MD
Investigator Role:
Principal Investigator
Investigator Affiliation:
University Hamburg
Authority:
Germany: Paul-Ehrlich-Institut
Study ID:
OSAG101-BSA05
NCT ID:
NCT00753246
Start Date:
August 2007
Completion Date:
January 2012
Related Keywords:
- Adults With Glioblastoma Multiforma
- glioblastoma multiforma
- Glioblastoma
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