Safety Study of Cetuximab, Radiotherapy and Temozolomide in Primary Glioblastoma Multiforme(GERT)
Glioblastoma Multiforme
About this trial
This is an interventional treatment trial for Glioblastoma Multiforme focused on measuring Cetuximab
Eligibility Criteria
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
Sites / Locations
- University of HeidelbergRecruiting