Cilengitide, Temozolomide, and Radiation Therapy in Treating Patients With Newly Diagnosed Glioblastoma and Unmethylated Gene Promoter Status

Inclusion Criteria

• Newly diagnosed histologically proven supratentorial glioblastoma (World Health Organization [WHO] Grade IV, including glioblastoma subtypes, for example, gliosarcoma). The histological diagnosis has to be obtained from a neurosurgical resection of the tumor or by an open biopsy (stereotactic biopsy is not allowed)
• Tumor tissue specimens from the glioblastoma surgery or open biopsy (formalin-fixed paraffin-embedded) must be available for MGMT gene promoter status analysis and central pathology review
• Proven unmethylated MGMT gene promoter status (that is, cut-off ratio less than ( =) 18 years of age
• Interval of >= 2 weeks but less than or equal to (= = 5 days prior to randomization
• Eastern Cooperative Oncology Group Performance Status (ECOG PS) of 0-1
• Has to meet 1 of the following recursive partitioning analysis (RPA) classifications:
• Class III (Age = 50 years, underwent prior partial or total tumor resection, Mini Mental State Examination [MMSE] >= 27)
• Class V (meeting one of the following criteria: a) Age >= 50 years and underwent prior partial or total tumor resection, MMSE = 50 years and underwent prior tumor biopsy only)
• Other protocol defined inclusion criteria could apply

Exclusion Criteria

• Prior chemotherapy within the last 5 years
• Prior RTX of the head (except for low dose RTX for tinea capitis)
• Receiving concurrent investigational agents or has received an investigational agent within the past 30 days prior to the first dose of cilengitide
• Prior systemic anti-angiogenic therapy
• Placement of Gliadel® wafer at surgery
• Planned surgery for other diseases
• History of recent peptic ulcer disease (endoscopically proven gastric ulcer, duodenal ulcer, or esophageal ulcer) within 6 months of enrollment
• 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
• History of coagulation disorder associated with bleeding or recurrent thrombotic events
• 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
• Inability to undergo Gd-MRI
• Concurrent illness, including severe infection (for example, human immunodeficiency virus), which may jeopardize the ability of the subject to receive the procedures outlined in this protocol with reasonable safety
• Subject is pregnant (positive serum beta human chorionic gonadotropin [b-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
• Current alcohol dependence or drug abuse
• Known hypersensitivity to the study treatment
• Legal incapacity or limited legal capacity
• Presence of any psychological, familial, sociological, or geographical condition potentially hampering compliance with the study protocol and follow-up schedule
• Signs and symptoms suggestive of transmissible spongiform encephalopathy, or family members who suffer(ed) from such
• Other protocol defined exclusion criteria could apply