Status:
UNKNOWN
Safety Study of Cetuximab, Radiotherapy and Temozolomide in Primary Glioblastoma Multiforme(GERT)
Lead Sponsor:
Heidelberg University
Collaborating Sponsors:
Merck KGaA, Darmstadt, Germany
Conditions:
Glioblastoma Multiforme
Eligibility:
All Genders
18-70 years
Phase:
PHASE1
PHASE2
Brief Summary
GERT is a one-armed single-center phase I/II trial. In a first step, dose-escalation of TMZ from 50 mg/m2 to 75mg/m2 together with radiotherapy and cetuximab will be performed. Should safety be proven...
Eligibility Criteria
Inclusion
- \>= 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
- 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
Key Trial Info
Start Date :
February 1 2006
Trial Type :
INTERVENTIONAL
End Date :
Estimated Enrollment :
46 Patients enrolled
Trial Details
Trial ID
NCT00311857
Start Date
February 1 2006
Last Update
September 8 2006
Active Locations (1)
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1
University of Heidelberg
Heidelberg, Baden-Wurttemberg, Germany, 69120