Newly diagnosed glioblastoma multiforme with unmethylated MGMT gene promoter status MedDRA version: 9.1 Level: LLT Classification code 10018337 Term: Glioblastoma multiforme
Conditions
Sponsors
Merck KGaA
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Written informed consent obtained before undergoing any study-related activities. 2. Newly diagnosed histologically proven supratentorial GBM (World Health Organization [WHO] Grade IV, including GBM subtypes, e.g. gliosarcoma). The histological diagnosis must be obtained from a neurosurgical resection of the tumor or by an open biopsy (stereotactic biopsy not allowed). 3. Tumor tissue specimens from the GBM surgery or open biopsy (formalin-fixed paraffin-embedded [FFPE] block) must be available for MGMT gene promoter status analysis and central pathology review. 4. Proven unmethylated MGMT gene promoter status (i.e. cut-off ratio =65 years) yes F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: 1. Prior chemotherapy within the last 5 years. 2. Prior RTX of the head (except for low dose radiotherapy for Tinea capitis). 3. Receiving concurrent investigational agents or has received an investigational agent within the past 30 days prior to the first dose of cilengitide. 4. Prior systemic antiangiogenic therapy. 5. Placement of Gliadel® wafer at surgery. 6. Planned major surgery for other diseases (e.g. dental extraction). 7. History of recent peptic ulcer disease (endoscopically proven gastric ulcer, duodenal ulcer, or esophageal ulcer) within 6 months of enrollment. 8. History of malignancy. Subjects with curatively treated cervical carcinoma in situ or basal cell carcinoma of the skin, or subjects who have been free of other malignancies for ‡5 years are eligible for this study. 9. History of coagulation disorder associated with bleeding or recurrent thrombotic events. 10. Clinically manifest myocardial insufficiency (New York Heart Association [NYHA] III, IV) or history of myocardial infarction during the past 6 months; or uncontrolled arterial hypertension. 11. Inability to undergo Gd-MRI. 12. Concurrent illness, including severe infection, which may jeopardize the ability of the subject to receive the procedures outlined in this protocol with reasonable safety. 13. Subject is pregnant (positive serum beta human chorionic gonadotropin [b-HCG] test at screening) or is currently breast-feeding, or has the potential and anticipates becoming pregnant/ impregnating their partner during the study or within 6 months after study participation, or subject does not agree to follow acceptable methods of birth control, such as hormonal contraception, intra-uterine pessar, condoms or sterilization, to avoid conception during the study and for at least 6 months after receiving the last dose of study treatment. 14. Current alcohol dependence or drug abuse. 15. Known hypersensitivity to the study treatment. 16. Legal incapacity or limited legal capacity. 17. Presence of any psychological, familial, sociological, or geographical condition potentially hampering compliance with the study protocol and follow-up schedule.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: Overall survival time;Secondary Objective: • Progression free survival time. • Safety and tolerability of the combination of cilengitide with standard RTX and TMZ . • PK profile of cilengitide when given daily (5 out of 7 days) at 2000 mg in combination with RTX and TMZ on days of RTX.;Primary end point(s): To investigate the overall survival (OS) time in subjects receiving 2 different regimens of 2000 mg cilengitide in combination with RTX and TMZ standard therapy. | — |
Countries
Austria, Czech Republic, France, Hungary, Italy, Spain
Outcome results
None listed