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

NCT00311857 | Unknown Phase 1

• 2 other identifiers: Eudract-2005-003911-63PEI 119/01
• Study Type: interventional
• Target: 46
• Locations: 1 country
• Sites: 1

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, 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.

Conditions

Glioblastoma Multiforme

Keywords

Cetuximab

Outcome Measures

Primary Outcomes (1)

• Toxicity

Secondary Outcomes (1)

• Overall survival

Interventions

Cetuximab DRUG

Temozolomide DRUG

Radiation therapy PROCEDURE

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• \>= 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Heidelberg University: lead
• Merck KGaA, Darmstadt, Germany: collaborator

Study Sites (1)

University of Heidelberg

Heidelberg, Baden-Wurttemberg, 69120, Germany

RECRUITING

MeSH Terms

Conditions

Glioblastoma

Interventions

Cetuximab; Temozolomide; Radiotherapy

Condition Hierarchy (Ancestors)

Astrocytoma; Glioma; Neoplasms, Neuroepithelial; Neuroectodermal Tumors; Neoplasms, Germ Cell and Embryonal; Neoplasms by Histologic Type; Neoplasms; Neoplasms, Glandular and Epithelial; Neoplasms, Nerve Tissue

Intervention Hierarchy (Ancestors)

Antibodies, Monoclonal, Humanized; Antibodies, Monoclonal; Antibodies; Immunoglobulins; Immunoproteins; Blood Proteins; Proteins; Amino Acids, Peptides, and Proteins; Serum Globulins; Globulins; Dacarbazine; Triazenes; Organic Chemicals; Imidazoles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Therapeutics

Study Officials

• Daniela Schulz-Ertner, MD

  Heidelberg University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Daniela Schulz-Ertner, MD

CONTACT

+49-6221-56; Daniela.Ertner@med.uni-heidelberg.de

Stephanie E Combs, MD

CONTACT

+49-6221-56; Stephanie.Combs@med.uni-heidelberg.de

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: April 5, 2006
• First Posted: April 6, 2006
• Study Start: February 1, 2006
• Last Updated: September 8, 2006

Record last verified: 2006-09

Locations

DE (1)