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Phase III Trial of CCNU/Temozolomide (TMZ) Combination Therapy vs. Standard TMZ Therapy for Newly Diagnosed MGMT-methylated Glioblastoma Patients

Phase 3
18 Years
70 Years
Open (Enrolling)

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Trial Information

Phase III Trial of CCNU/Temozolomide (TMZ) Combination Therapy vs. Standard TMZ Therapy for Newly Diagnosed MGMT-methylated Glioblastoma Patients

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)

Type of Study:


Study Design:

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

overall survival

Outcome Time Frame:

after follow up (4 years)

Safety Issue:


Principal Investigator

Ulrich Herrlinger, Prof. Dr.

Investigator Role:

Study Director

Investigator Affiliation:

Division of Neurooncology, Departement of Neurology, University Hospital Bonn


Germany: Ethics Commission

Study ID:




Start Date:

October 2010

Completion Date:

February 2015

Related Keywords:

  • Glioblastoma
  • MGMT promotor status
  • overall survival
  • Glioblastoma