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

• Status: Unknown status
• Trial end date: 1969-12-31
• Target enrollment: 0
• Participant gender: All

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, 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.

• Phase: Phase 1/Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Heidelberg University
• Collaborators: Merck KGaA; Merck KGaA, Darmstadt, Germany
• Treatments: Cetuximab; Dacarbazine; Temozolomide

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