Phase I/II Trial Evaluating Toxicity and Efficacy of Adding Stereotactic Body Radiotherapy to Sorafenib in Patients With Metastatic, Recurrent, or Unresectable Renal Cell Cancer

• Age > 18 years old

• Zubrod Performance Status 0 or 1

• Adequate bone marrow, liver and renal function as assessed by the following:

• Hemoglobin > 9.0 g/dl

• Absolute neutrophil count (ANC) > 1,500/mm3

• Platelet count > 100,000/mm3

• Total bilirubin < 1.5 times institutional upper limit of normal (ULN)

• Alanine aminotransferase (ALT) and aspartate aminotransferase (AST) < 2.5 times the institutional ULN

• Creatinine < 1.5 times institutional ULN

• Histologically or cytologically confirmed renal cell carcinoma, which is metastatic, unresectable or recurrent.

• Life expectancy > 6 months

• Local recurrence or progression of primary lesion or progression, or symptomatic progression in extra-cranial, extra-pulmonary metastases while on sorafenib

• Measurable disease

• Bone metastases must have a tissue component measurable by imaging.

• No untreated brain metastases

• Resolution of pre-existing toxicity from prior therapy excluding alopecia and taste alteration.

• Willingness and ability to comply with continuing sorafenib, visits, treatment plans, laboratory tests and study procedures.

• All treated lesions must comply with SBRT dose constraints

• More than 28 days since any prior systemic or local therapy for this cancer, including investigational agents and surgical procedures exclusive of sorafenib

• Women of childbearing potential and men must agree to use adequate contraception (barrier method of birth control)

• Women of childbearing potential must have a negative serum pregnancy test performed within 7 days prior to the start of treatment.

• Ability to understand and the willingness to sign a written informed consent.

• Prothrombin time(PT) and partial thromboplastin time (PTT) within normal limits.