PTK787/ZK 222584 in Combination With Temozolomide and Radiation in Patients With Glioblastoma Taking Enzyme-Inducing Anti-Epileptic Drugs

Inclusion Criteria:

• All patients must have histologically verified glioblastoma. Patients mus have paraffin blocks of tumor that must be sent for analysis.
• 18 years of age or older
• Karnofsky Performance Status greater than or equal to 60
• Adequate laboratory values as described by the protocol
• Life expectancy of greater than 12 weeks
• Patient must be able to undergo serial MR imaging
• Patients must be on an enzyme-inducing anti-epileptic drug(s) as listed in the protocol
• No steroids or a stable dose of steroids for at least 5 days or a decreasing dose
• Mini-mental status examination of 15 or greater

Exclusion Criteria:

• Pregnant or breast-feeding women
• Concurrent malignancy except curatively treated basal or squamous cell carcinoma of the skin or carcinoma in situ of the cervix or breast
• Prior chemotherapy or cranial radiation therapy for glioblastoma
• Prior biologic or immunotherapy less than 2 weeks prior to registration
• If the patient surgery is more than 16 days or less than 13 days from the start of PTK787/ZK 222854
• Prior therapy with anti-VEGF agents
• Pleural effusion or ascites that causes respiratory compromise
• Concurrent severe and/or uncontrolled medical conditions which could compromise participation is the study
• Impairment of gastrointestinal function or GI disease that may significantly alter the absorption of PTK787/ZK 222584
• Confirmed diagnosis of human immunodeficiency virus (IV)
• Patients who are taking therapeutic warfarin sodium or other anticoagulants or anti-platelet agents
• Patients requiring aprepitant, dolasetron, and tropisetron as antiemetics are excluded