Safety Study of Cetuximab, Radiotherapy and Temozolomide in Primary Glioblastoma Multiforme(GERT)

Study Overview
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Brief Summary
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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, the phase II trial will be initiated with the standard dose of 75mg/m2 of TMZ. Cetuximab will be applied in the standard application dose of 400mg/m2 in week 1, thereafter at a dose of 250mg/m2 weekly. A total of 46 patients will be included into this phase I/II trial. Primary endpoints are feasibility and toxicity, secondary endpoints are overall and progression-free survival. An interim analysis will be performed after inclusion of 15 patients into the main study. Patients' enrolment will be performed over a period of 2 years. The observation time will end 2 years after inclusion of the last patient.

Official Title
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Treatment of Primary Glioblastoma Multiforme With Cetuximab, Radiotherapy and Temozolomide (GERT) - Phase I/II Trial

Conditions
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Glioblastoma Multiforme

Intervention / Treatment
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* Drug: Cetuximab
* Drug: Temozolomide
* Procedure: Radiation therapy


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 70 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: Cetuximab|nan|
|Drug: Temozolomide|nan|
|Procedure: Radiation therapy|nan|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Toxicity |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Overall survival |  |  | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Cetuximab