Bortezomib, Temozolomide, and Regional Radiation Therapy in Treating Patients With Newly Diagnosed Glioblastoma Multiforme or Gliosarcoma

Exclusion Criteria

• •peripheral neuropathy ≥ grade 2
• •Myocardial infarction within the past 6 months
• •New York Heart Association (NYHA) class III or IV heart failure
• •Uncontrolled angina
• •Severe uncontrolled ventricular arrhythmias
• •Electrocardiographic evidence of acute ischemia or active conduction system abnormalities
• •hypersensitivity to bortezomib, boron, or mannitol
• •serious medical or psychiatric illness that would interfere with study participation including, but not limited to, any of the following:
• •Ongoing or active infection requiring IV antibiotics
• •Psychiatric illness and/or social situations that would limit compliance with study requirements
• •Disorders associated with a significant immunocompromised state (e.g., HIV, systemic lupus erythematosus)
• •history of stroke within the past 6 months
• •other malignancy within the past 3 years except completely resected basal cell carcinoma or squamous cell carcinoma of the skin, an in situ malignancy (i.e., cervical cancer), or low-risk prostate cancer after curative therapy
• •significant medical illness that, in the investigator's opinion, cannot be adequately controlled with appropriate therapy or would compromise the patient's ability to tolerate this therapy
• •disease that will obscure toxicity or dangerously alter drug metabolism
• •viral hepatitis (HBV surface antigen positive) or active hepatitis C infection
• •Prior or concurrent corticosteroids, automated external defibrillator, analgesics, and other drugs to treat symptoms or prevent complications allowed
• •concurrent investigational drugs that must be stopped at least 4 months prior to therapy.
• •prior radiotherapy to the brain
• •prior cytotoxic or noncytotoxic drug therapy or experimental drug therapy (including chemotherapy, hormonal therapy, or immunotherapy) directed against the brain tumor
• •prior polifeprosan 20 with carmustine implant (Gliadel wafer)
• •concurrent stereotactic radiosurgery or brachytherapy
• •concurrent sargramostim
• •concurrent inducers of CYP450 3A4 (e.g., enzyme-inducing anti-epileptic drugs \[EIAED\])