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

Glioblastoma Multiforme Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT00311857
• Other study ID #: Eudract-2005-003911-63
• Secondary ID: PEI 119/01
• Status: Recruiting
• Phase: Phase 1/Phase 2
• First received: April 5, 2006
• Last updated: September 7, 2006
• Start date: February 2006

Study information

• Verified date: September 2006
• Source: Heidelberg University
• Contact: Daniela Schulz-Ertner, MD
• Phone: +49-6221-56
• Email: Daniela.Ertner[@]med.uni-heidelberg.de
• Is FDA regulated: No
• Health authority: Germany: Federal Institute for Drugs and Medical Devices
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 46
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 70 Years

Eligibility

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

Study Design

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Glioblastoma
• Glioblastoma Multiforme

Intervention

Drug:
• Cetuximab

• Temozolomide

Procedure:
• Radiation therapy

Locations

Country	Name	City	State
Germany	University of Heidelberg	Heidelberg	Baden-Württemberg

Sponsors (2)

Lead Sponsor	Collaborator
Heidelberg University	Merck KGaA

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Toxicity
Secondary	Overall survival