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

Study Purpose

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 Criteria

Accepts Healthy Volunteers

Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms

 No
Study Type

An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes.


An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes.


Searching Both is inclusive of interventional and observational studies.

 Interventional
Eligible Ages 18 Years - 70 Years
Gender All
More Inclusion & Exclusion 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

Trial Details

Trial ID:

This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.

 NCT00311857
Phase

Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans.

Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data.

Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs.

Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.

 Phase 1/Phase 2
Lead Sponsor

The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.

 Heidelberg University
Principal Investigator

The person who is responsible for the scientific and technical direction of the entire clinical study.

 Daniela Schulz-Ertner, MD
Principal Investigator Affiliation Heidelberg University
Agency Class

Category of organization(s) involved as sponsor (and collaborator) supporting the trial.

 Other, Industry
Overall Status Unknown status
Countries Germany
Conditions

The disease, disorder, syndrome, illness, or injury that is being studied.

 Glioblastoma Multiforme

Contact a Trial Team

If you are interested in learning more about this trial, find the trial site nearest to your location and contact the site coordinator via email or phone. We also strongly recommend that you consult with your healthcare provider about the trials that may interest you and refer to our terms of service below.

International Sites

University of Heidelberg, Heidelberg, Baden-Württemberg, Germany

Status

Recruiting

Address

University of Heidelberg

Heidelberg, Baden-Württemberg, 69120

Site Contact

Daniela Schulz-Ertner, MD

[email protected]

+49-6221-56 #8201

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