patients with a recurrent glioblastoma multiforme following preceding surgery, radiation therapy and chemotherapy
Conditions
Interventions
Product Name: Cetuximab
Product Code: EMD271786
Pharmaceutical Form: Solution for infusion
Sponsors
Oncologisch Centrum, Academisch Ziekenhuis Vrije Universiteit Brussel
Eligibility
Sex/Gender
All
Inclusion criteria
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
Exclusion criteria: Standard phase II exclusion criteria for cytotoxic drug studies and Cetuximab studies.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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). | — |
Countries
Spain
Outcome results
None listed