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Phase-III Study of Standard Radiotherapy Plus Concomitant and Adjuvant OSAG 101 (TheralocĀ®) Plus Temozolomide vs. Standard Radiotherapy Plus Concomitant and Adjuvant Temozolomide in Patient With Newly Diagnosed, Histologically Confirmed Glioblastoma Multiforme Grade IV


Phase 3
18 Years
70 Years
Not Enrolling
Both
Adults With Glioblastoma Multiforma

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Trial Information

Phase-III Study of Standard Radiotherapy Plus Concomitant and Adjuvant OSAG 101 (TheralocĀ®) 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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