Nimotuzumab in Adults With Glioblastoma Multiforma facts

From http://clinicaltrials.gov "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."

Medical trial

ClinicalTrials.gov Identifier:

NCT00753246

Sponsor:

Oncosciences AG

Type of trial:

Interventional

Design:

View entire collection »

Start date:

Aug 2007

End date:

Aug 2010

Phase:

Expected total enrollment:

Eligibile genders:

View entire collection »

Minimum age for eligibility:

Maximum age for eligibility:

Eligibility inclusion criteria:

Patient signed informed consent
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
Treatment in a study center
Newly diagnosed, histologically confirmed glioblastoma multiforme grade IV
Karnofsky-Index > 40
Condition is measurable by MRI in at least one dimension
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.

Eligibility exclusion criteria:

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
Patients with evidence second malignancy
Patients who are pregnant or patients who refused adequate contraceptive precaution (female and male) during the trial
No MRI for tumour evaluation
Patients with history of anaphylactic reaction to murine or humanized antibody

Location:

Hamburg

Health authority:

Paul-Ehrlich-Institut

Contact:

View entire collection »

Diseases:

Glioblastoma multiforme

top ↑

These people have edited this topic:

bgood
- Member Since: May 21, 2007
- Contributions: 612 Facts

Edit this topic

Last edited Sep 7, 2009 See all topic history »

Elsewhere on the web

Clinical Trials

Nimotuzumab in Adults With Glioblastoma Multiforma

Medical trial

ClinicalTrials.gov Identifier:

Sponsor:

Type of trial:

Design:

Start date:

End date:

Phase:

Expected total enrollment:

Eligibile genders:

Minimum age for eligibility:

Maximum age for eligibility:

Eligibility inclusion criteria:

Eligibility exclusion criteria:

Location:

Health authority:

Contact:

Diseases:

These people have edited this topic:

bgood

Elsewhere on the web

What is Freebase?

Flag this Topic

Why do you want to flag this topic?

Nimotuzumab in Adults With Glioblastoma Multiforma

Medical trial

ClinicalTrials.gov Identifier:

Sponsor:

Type of trial:

Design:

Start date:

End date:

Phase:

Expected total enrollment:

Eligibile genders:

Minimum age for eligibility:

Maximum age for eligibility:

Eligibility inclusion criteria:

Eligibility exclusion criteria:

Location:

Health authority:

Contact:

Diseases:

These people have edited this topic:

bgood

Related Topics

Elsewhere on the web

What is Freebase?

Flag this Topic

Why do you want to flag this topic?