Temozolomide and Procarbazine With Cilengitide for Patients With Glioblastoma Multiforme Without Methylation of the MGMT Promoter Gene

Exclusion Criteria

• •1. Prior chemotherapy within the last 5 years.
• •2. Prior RTX of the head.
• •3. Receiving concurrent investigational agents or has received an investigational agent(s) 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. Treatment with a prohibited concomitant medication.
• •7. Planned surgery for other diseases (e.g. dental extraction).
• •8. History of recent peptic ulcer disease (endoscopically proven gastric ulcer, duodenal ulcer, or esophageal ulcer) within 6 months of enrollment.
• •9. 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.
• •10. History of coagulation disorder associated with bleeding or recurrent thrombotic events.
• •11. Clinically manifest myocardial insufficiency (NYHA III, IV) or history of myocardial infarction during the past 6 months. Uncontrolled arterial hypertension.
• •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 \[β-HCG\] test at screening) or is currently breast-feeding, 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. Inability to undergo Gd-MRI.
• •18. Presence of any psychological, familial, sociological or geographical condition potentially hampering compliance with the study protocol and follow-up schedule.
• •19. Signs and symptoms suggestive of transmissible spongiform encephalopathy, or of family members who suffer(ed) from such.