Treatment of Primary Glioblastoma Multiforme With Cetuximab, Radiotherapy and Temozolomide (GERT) – Phase I/II Trial
Inclusion Criteria:
- >= 18 and < 70 years of age
- Karnofsky Performance Score >= 60
- histologically confirmed supratentorial GBM
- interval between primary diagnosis and registration for the study < 4 weeks
- patients will be included according to the incidental gender distribution for
patients with GBM of ♀/♂ 2:3
- adequate blood values (not older than 14 days prior to initiation of RCHT)
- neutrophil count (ANC) ≥1500/mm3 or white blood cells (WBC) ≥2000/mm3
- platelets ≥100.000/mm3
- hemoglobin ≥10g/dL
- BUN <1.5 times the upper range
- Total and direct bilirubin <1.5times the upper laboratory limit
- Adequate liver enzymes <3 times the upper laboratory limit
- Life expectancy >12 weeks
- Written informed consent
Exclusion Criteria:
- refusal of the patients to take part in the study
- previous radiotherapy of the brain or chemotherapy with DTIC or TMZ
- known allergy against extrinsical proteins
- previous chemotherapy or therapy with an EGFR-inhibitor
- Previous antibody therapy
- Patients who have not yet recovered from acute toxicities of prior therapies
- Acute infections requiring systemic application of antibiotics
- Frequent vomiting or a medical condition preventing the oral application of TMZ
- Clinically active kidney- liver or cardiac disease
- Known carcinoma < 5 years ago (excluding Carcinoma in situ of the cervix, basal cell
carcinoma, squamous cell carcinoma of the skin)
- HIV
- Pregnant or lactating women
- Participation in another clinical study