Glioblastoma MultiformePhase 1/2NCT00311857
Safety Study of Cetuximab, Radiotherapy and Temozolomide in Primary Glioblastoma Multiforme(GERT)
A Phase 1/2 study testing Cetuximab, Temozolomide and Radiation therapy in people with Glioblastoma Multiforme, run by Heidelberg University at 1 site in Germany.
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. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Glioblastoma Multiforme
- What is being tested?
- Cetuximab, Temozolomide and Radiation therapy
- Type of treatment
- Surgery or procedure
- How many people
- 46 participants
- Where
- 1 siteGermany
- Study dates
- Feb 2006to not given
- Phase
- Phase 1/2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- >= 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)
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- 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
Who cannot join
- 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
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- 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 locations and contacts
1 site in 1 country.
Germany1 site, 1 recruiting
- Recruiting
University of Heidelberg
Heidelberg, Baden-Wurttemberg, 69120
Daniela Schulz-Ertner, MD, +49-6221-56 ext. 8201, Daniela.Ertner@med.uni-heidelberg.de
Stephanie E Combs, MD, +49-6221-56 ext. 8201, Stephanie.Combs@med.uni-heidelberg.de
About this study
Official title: Treatment of Primary Glioblastoma Multiforme With Cetuximab, Radiotherapy and Temozolomide (GERT) - Phase I/II Trial
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
- Being tested
- Cetuximab, Temozolomide, Radiation therapy
- Keywords
- Cetuximab
- Medical subject headings
- Glioblastoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CetuximabDrug
TemozolomideDrug
Radiation therapyProcedure or surgery
What is being measured
The primary outcome is the main question the study is designed to answer.
Toxicity
Secondary outcomes (1)
Overall survival
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Apr 2006 (estimated)
- Study startFeb 2006
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Glioblastoma MultiformeStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1/2
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 46 participants
Sponsor and investigators
- Lead sponsor
- Heidelberg University
- Sponsor type
- University, hospital or other
- Collaborators
- Merck KGaA, Darmstadt, Germany
- Investigators
- Daniela Schulz-Ertner, MD, Principal investigator, Heidelberg University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00311857
- Sponsor's protocol ID
- Eudract-2005-003911-63
- Other IDs
- PEI 119/01
- Status last verified
- Sep 2006
- First submitted
- 5 Apr 2006
- Last updated
- 8 Sep 2006
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Sep 2006. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Treatment of Primary Glioblastoma Multiforme With Cetuximab, Radiotherapy and Temozolomide (GERT) - Phase I/II Trial
- ClinicalTrials.gov ID
- NCT00311857
- Acronym / sponsor ID
- Eudract-2005-003911-63
- Conditions
- Glioblastoma Multiforme
- Keywords
- Cetuximab
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 46 participants
- Lead sponsor
- Heidelberg UniversityUniversity, hospital or other
- Collaborators
- Merck KGaA, Darmstadt, Germany
- Study start
- Feb 2006
- First posted
- 6 Apr 2006 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (14 listed)
- >= 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
Key exclusion criteria (13 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Cetuximab | Drug | – |
| Temozolomide | Drug | – |
| Radiation therapy | Procedure or surgery | – |
Primary outcome
Toxicity
1 secondary outcome
Overall survival
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Sep 2006.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Daniela Schulz-Ertner, MD principal investigator
Heidelberg University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing Cetuximab, Temozolomide and Radiation therapy in people with Glioblastoma Multiforme, run by Heidelberg University at 1 site in Germany.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 14 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 8 Sep 2006. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Daniela Schulz-Ertner, MD (+49-6221-56 ext. 8201, Daniela.Ertner@med.uni-heidelberg.de), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Toxicity. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Sep 2006; AzTrials last refreshed its copy on 8 Nov 2026.