Phase I Study of the Combination of Sorafenib and Radiation Therapy -/+ Temozolomide for the Treatment of Patients With Brain Metastases and Primary Brain Tumors

Inclusion Criteria:

1. Patients requiring a minimum 2-week course of radiation therapy

2. Age > or = 18

3. All tumors of the central nervous system, or metastasis to the central nervous
system.

4. Measurable disease preferred but not required for eligibility

5. Histologically or cytologically documented evidence of malignancy (for infratentorial
and supratentorial glioma patients only).

6. Radiographic evidence of brain metastasis

7. ECOG performance status of 0 or 1

8. Life expectancy of > or = 3 months

Exclusion Criteria:

1. Patients receiving chemotherapy or other investigational drugs must be discontinued
14 days prior to enrollment.

2. Cardiac disease: Congestive heart failure > class II NYHA. Patients must not have
unstable angina (anginal symptoms at rest) or new onset angina (began within the last
3 months) or myocardial infarction within the past 6 months.

3. Cardiac ventricular arrhythmias requiring anti-arrhythmic therapy.

4. Uncontrolled hypertension defined as systolic blood pressure > 150 mmHg or diastolic
pressure > 90 mmHg, despite optimal medical management.

5. Known human immunodeficiency virus (HIV) infection or chronic Hepatitis B or C.

6. Active clinically serious infection > CTCAE Grade 2