Status:
COMPLETED
Efficacy and Safety Study of Lomustine/Temozolomide Combination Therapy vs. Standard Therapy for Glioblastoma Patients
Lead Sponsor:
University Hospital, Bonn
Conditions:
Glioblastoma
Eligibility:
All Genders
18-70 years
Phase:
PHASE3
Brief Summary
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 overal...
Eligibility Criteria
Inclusion
- 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
- 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)
Key Trial Info
Start Date :
October 1 2010
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
April 6 2017
Estimated Enrollment :
141 Patients enrolled
Trial Details
Trial ID
NCT01149109
Start Date
October 1 2010
End Date
April 6 2017
Last Update
June 14 2017
Active Locations (12)
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1
Depatment of Neurosurgery, Charité, University Hospital Berlin
Berlin, Germany, 13353
2
Department of Neurology, University Hospital Bochum
Bochum, Germany, 44892
3
Department of Neurology, University Hospital Bonn
Bonn, Germany, 53105
4
Department of Neurosurgery, University Hospital Cologne
Cologne, Germany, 50937