Low-Dose Whole-Brain Radiation Therapy and Temozolomide in Treating Patients With Newly Diagnosed Glioblastoma Multiforme

Inclusion Criteria

• Histologically proven diagnosis of glioblastoma or gliosarcoma (World Health Organization [WHO] grade IV)
• Infratentorial tumors are eligible
• History and physical with neurological examination, steroid documentation, height, and weight within 14 days of registration
• A diagnostic contrast-enhanced magnetic resonance imaging (MRI) of the brain must be performed preoperatively and postoperatively prior to the initiation of radiotherapy; the postoperative scan must be performed within 28 days prior to registration; (contrast enhanced brain computed tomography [CT] is allowed if MRI is contraindicated)
• Karnofsky performance status >= 70 or Eastern Cooperative Oncology Group (ECOG) performance status =< 2
• Absolute neutrophil count (ANC) >= 1,800 cells/mm^3 (within 14 days prior to registration)
• Platelets >= 100,000 cells/mm^3 (within 14 days prior to registration)
• Hemoglobin >= 10.0 g/dl (Note: the use of transfusion or other intervention to achieve hemoglobin [Hgb] >= 10.0 g/dl is acceptable) (within 14 days prior to registration)
• Blood urea nitrogen (BUN) =< 30 mg/dl (within 14 days prior to registration)
• Creatinine =< 1.7 mg/dl (within 14 days prior to registration)
• Bilirubin =< 2.0 mg/dl (within 14 days prior to registration) * Please note that if the liver function tests are abnormal, the decision to initiate temozolomide treatment should carefully consider the benefits and risks to the individual patient
• Alanine aminotransferase (ALT)/aspartate aminotransferase (AST) =< 3 x upper limit of normal (ULN) (within 14 days prior to registration) * Please note that if the liver function tests are abnormal, the decision to initiate temozolomide treatment should carefully consider the benefits and risks to the individual patient
• Systolic blood pressure =< 160 mg Hg or diastolic pressure =< 90 mg Hg within 14 days prior to registration
• Patient must provide study specific informed consent prior to study entry
• For women of child-bearing potential, negative serum pregnancy test within 14 days prior to registration
• Women of childbearing potential and male participants must practice adequate contraception

Exclusion Criteria

• Prior invasive malignancy (except for non-melanomatous skin cancer) unless disease free for >= 3 years; for example, carcinoma in situ of the breast, oral cavity, and cervix are all permissible
• Metastases beyond the cranial vault
• Prior use of Gliadel wafers or any other intratumoral or intracavitary treatment is not permitted
• Prior radiotherapy to the head or neck (except for T1 glottic cancer), resulting in significant overlap of radiation fields
• Severe, active co-morbidity, defined as follows: * Unstable angina and/or congestive heart failure within the last 6 months * Transmural myocardial infarction within the last 6 months * New York Heart Association grade II or greater congestive heart failure requiring hospitalization within 12 months prior to registration * History of stroke, cerebral vascular accident (CVA) or transient ischemic attack within 6 months * Serious and inadequately controlled cardiac arrhythmia * Significant vascular disease (e.g., aortic aneurysm, history of aortic dissection) or clinically significant peripheral vascular disease * Evidence of bleeding diathesis or coagulopathy * Serious or non-healing wound, ulcer, or bone fracture or history of abdominal fistula, gastrointestinal perforation or intra-abdominal abscess, major surgical procedure or significant traumatic injury within 28 days prior to registration, with the exception of the craniotomy for tumor resection or follow-on craniotomies to manage complications of brain tumor management such as hemorrhage or infection * Bacterial or fungal infection requiring intravenous antibiotics at the time of registration * Chronic obstructive pulmonary disease exacerbation or other respiratory illness requiring hospitalization or precluding study therapy at the time of registration * Hepatic insufficiency resulting in clinical jaundice and/or coagulation defects; note, however, that laboratory tests for coagulation parameters are not required for entry into this protocol * Acquired immune deficiency syndrome (AIDS) based upon current Centers for Disease Control and Prevention (CDC) definition; note, however, that human immunodeficiency virus (HIV) testing is not required for entry into this protocol * Active connective tissue disorders, such as lupus or scleroderma, that in the opinion of the treating physician may put the patient at high risk for radiation toxicity * Any other major medical illnesses or psychiatric impairments that in the investigator's opinion will prevent administration or completion of protocol therapy * Cognitive impairment that precludes a patient from acting as his or her own agent to provide informed consent
• Women of childbearing potential and men who are sexually active and not willing/able to use medically acceptable forms of contraception; this exclusion is necessary because the chemotherapeutic treatment involved in this study is significantly teratogenic
• Pregnant or lactating women, due to possible adverse effects on the developing fetus or infant due to study treatment
• Patients treated on any other therapeutic clinical protocols within 30 days prior to study entry or during participation in the study