A Stratified Phase II Study of Cetuximab (ErbituxTM) for the Treatment of Recurrent Glioblastoma Multiforme / Estudio de fase II estratificado de cetuximab para el tratamiento del glioblastoma multiforme recidivante - Cetuximab for recurrent GBM

Conditions: patients with a recurrent glioblastoma multiforme following preceding surgery, radiation therapy and chemotherapy

Registration Number: EUCTR2005-000459-14-ES

Lead Sponsor: Oncologisch Centrum, Academisch Ziekenhuis Vrije Universiteit Brussel

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Authorised-recruitment may be ongoing or finished

Sex: All

Target Recruitment: 54

Inclusion Criteria

1.Recurrent GBM (de novo or secondary) after previous treatment by neurosurgery,
radiotherapy and temozolomide chemotherapy.
2.Availability of pretreatment tumor tissue for IHC and FISH analysis of the EGF-
Receptor and gene.
3.Measurable disease on GdMRI of the brain.
4.Proven disease progression on sequential GdMRI prior to study entry.
5.Life expectancy of at least 3 months and WHO-PS > 2.
6.A stable dose of corticosteroids for at least 1 week before study entry.
7.Standard phase II exclusion criteria for cytotoxic drug studies and Cetuximab
studies.
8. Informative result from EGFR FISH analysis on pretreatment GBM tissue.

Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

Standard phase II exclusion criteria for cytotoxic drug studies and Cetuximab
studies.

Study & Design

Study Type: Interventional clinical trial of medicinal product

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Main Objective: The primary objective of this study is to demonstrate the anti-tumor activity of Cetuximab treatment in patients with a recurrent glioblastoma multiforme (that either carries or does not carry an amplified/mutated EGFR gene). Anti-tumor activity will be defined as an objective CR or PR (with a duration of at least 4 weeks) following the adapted WHO criteria for tumor response in CNS tumors (MacDonald criteria).;Secondary Objective: Safety & toxicity, duration of response, 6-mths and median TTP, and overall survival.;Primary end point(s): The primary endpoint of this study is to demonstrate the anti-tumor activity of Cetuximab treatment in terms of objective tumor response. Anti-tumor response will be evaluated according to the Macdonald criteria. This will be done in patients with a recurrent GBM that either carries or does not carry an amplified/mutated EGFR gene (= 2 treatment strata).

Secondary Outcome Measures