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Efficacy and Safety Study of Lomustine/Temozolomide Combination Therapy vs. Standard Therapy for Glioblastoma Patients

Study Purpose

The prognosis of patients with newly diagnosed glioblastoma is dismal despite recent therapeutic improvements Using standard therapy with temozolomide (TMZ) and radiotherapy (60 Gy), the median overall survival time (mOS) is 14.6 months (Stupp et al., 2005). Since in a previous non-randomized bicentric phase II trial, primary combination chemotherapy with lomustine (CCNU) and TMZ was highly effective (mOS 23 months; UKT-03 trial; Herrlinger et al., 2006; Glas et al., 2009) the proposed trial further investigates the efficacy of CCNU/TMZ in a randomized multicenter phase III setting against standard therapy. In case the projected phase III trial confirms the phase II data, CCNU/TMZ combination would be significantly better than TMZ monotherapy and would thus be the new standard treatment for newly diagnosed GBM patients with a methylated MGMT promotor. Thus, this trial has the potential to profoundly change the standard therapy of this most aggressive brain tumor. Since in the previous trial only patients with a methylated MGMT (mMGMT) promoter had a benefit from CCNU/TMZ (mOS in the mMGMT group 34 months, in the non-mMGMT group 12.5 months; Glas et al., 2009) while patients with a non-methylated MGMT did not have any benefit, the trial is restricted to mMGMT patients.The CeTeG trial randomizes in a 1:1 fashion newly diagnosed GBM patients (18-70 years) for either standard TMZ therapy (concomitant and 6 courses à 4 weeks of adjuvant TMZ therapy) or experimental CCNU/TMZ therapy (6 courses à 6 weeks). Both arms include standard radiotherapy (RT) of the tumor site (30 x 2 Gy). Assuming that CCNU/TMZ therapy increases the median overall survival (mOS) from 48.9% (standard TMZ) to 70% (CCNU/TMZ; 75% in the previous phase II trial, Glas et al., 2009), 2 x 68 patients have to be accrued. Patients will be accrued over 24 months and each patient will be followed for at least 24 months adding up to a total minimal duration of the time from first patient in until the end of the follow-up time of 48 months. The primary endpoint is overall survival; secondary endpoints include progression-free survival, response rate, acute and late toxicity, and quality of life.

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:

  • - written informed consent.
  • - patients have to be in a cognitive state that allows them to understand the rationale and necessity of study therapy and procedures.
  • - newly diagnosed histologically proven GBM or gliosarcoma WHO Grad IV.
  • - methylated MGMT promoter in the tumor.
  • - estimated life expectancy of at least 12 weeks.
  • - Karnofsky Performance Score (KPS) ≥ 70% - patient compliance and geographic proximity that allow adequate follow up.
  • - male and female patients with reproductive potential must use an approved contraceptive method.
  • - pre-menopausal female patients with childbearing potential: a negative serum pregnancy test must be obtained prior to treatment start.
  • - Adequate organ function as described below: Adequate bone marrow reserve: white blood cell (WBC) count > 3000/µl, granulocyte count >1500/µl, platelets > 100000/µl, haemoglobin ≥ 10 g/dl Adequate liver function bilirubin < 1.5 times above upper limit of normal range (ULN), ALT and AST < 3 times ULN creatinine < 1.5 times ULN.
Adequate blood clotting: PT and PTT within normal limits Negative HIV test.

Exclusion Criteria:

  • - prior malignancy.
  • - prior chemotherapy.
  • - prior radiotherapy to the brain.
  • - concurrent administration of any other anti-tumor therapy.
  • - allergy or other intolerability of temozolomide, CCNU, dacarbazine or other nitrosourea derivatives.
  • - unable to undergo MRI.
  • - past medical history of diseases with poor prognosis.
  • - known HIV infection, active Hepatitis B or C infection.
  • - any active infection.
  • - female patients that are pregnant or breastfeeding.
  • - patients with reproductive potential who do not accept to use contraception.
  • - treatment in another clinical trial.
- any psychological, cognitive, familial, sociological or geographical condition potentially hampering compliance with the study protocol and follow-up scheduled visits (at the discretion of investigator)

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.

 NCT01149109
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 3
Lead Sponsor

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

 University Hospital, Bonn
Principal Investigator

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

 Ulrich Herrlinger, Prof. Dr.
Principal Investigator Affiliation Division of Neurooncology, Departement of Neurology, University Hospital Bonn
Agency Class

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

 Other
Overall Status Completed
Countries Germany
Conditions

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

 Glioblastoma
Study Website: View Trial Website
Arms & Interventions

Arms

Experimental: lomustine (CCNU) + temozolomide (TMZ) and radiotherapy

60 Gy standard radiotherapy (RT, 30 x 2 Gy) Six 42-day courses of oral CCNU 100 mg/m2 (day 1) and oral TMZ 100 mg/m2 (day 2-6), first CCNU application during the first week of RT CCNU/TMZ and radiotherapy start 2-5 weeks after diagnosis (day of surgery for glioblastoma (GBM)). In courses 2-6, TMZ dose are adjusted according to the hematotoxicity observed in the previous course and can be increased stepwise up to 200 mg/m2/day

Active Comparator: temozolomide and radiotherapy

60 Gy standard radiotherapy (RT, 30 x 2 Gy) and concomitant TMZ therapy (daily TMZ 75 mg/m2) starting with the first day of radiotherapy Six 28-day courses of TMZ (day 1-5) starting 4 weeks after completion of radiotherapy. In the first course TMZ is given at a dose of 150 mg/m2/day, in case no toxicity is observed, the 2nd course is applied at a daily dose of 200 mg/m2

Interventions

Drug: - Temozolomide and lomustine

Drug: - Temozolomide

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

Berlin, Germany

Status

Address

Depatment of Neurosurgery, Charité, University Hospital Berlin

Berlin, , 13353

Bochum, Germany

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Department of Neurology, University Hospital Bochum

Bochum, , 44892

Bonn, Germany

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Address

Department of Neurology, University Hospital Bonn

Bonn, , 53105

Cologne, Germany

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Department of Neurosurgery, University Hospital Cologne

Cologne, , 50937

Dresden, Germany

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Address

Department of Neurosurgery, University Hospital Dresden

Dresden, , 01307

Duesseldorf, Germany

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Department of Neurosurgery, University Hospital Duesseldorf

Duesseldorf, , 40225

Frankfurt, Germany

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Department of Neurosurgery, University Hospital Frankfurt

Frankfurt, , 60528

Leipzig, Germany

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Department of Radiooncology, University Hospital Leipzig

Leipzig, , 04103

Mannheim, Germany

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Address

Department of Neurosurgery, University of Heidelberg, Medical Faculty of Mannheim

Mannheim, , 68167

Muenster, Germany

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Address

Department of Neurosurgery, University Hospital Muenster

Muenster, , 48149

Munich, Germany

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Address

Department of Neurosurgery, University Hospital Munich (LMU)

Munich, , 81377

Regensburg, Germany

Status

Address

Department of Neurology, University Hospital Regensburg

Regensburg, , 93053

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