Stereotactic Body Radiation Therapy in Treating Patients With Metastatic Kidney Cancer Undergoing Surgery

PRIMARY OBJECTIVES:

I. Assess the impact of stereotactic body radiation therapy (SBRT) on the immune system in
patients with metastatic renal cell carcinoma (RCC).

SECONDARY OBJECTIVES:

I. Assess changes in immune parameters prior to radiation, post radiation and post
nephrectomy.

TERTIARY OBJECTIVES:

I. Assess surgical parameters for partial or radical nephrectomy post SBRT.

OUTLINE:

Patients undergo SBRT on day 1 and undergo partial or radical nephrectomy on day 29.

After completion of study treatment, patients are followed up at 30 days.

Inclusion Criteria:

- Have metastatic RCC with primary tumor in place

- Must be surgical candidates as deemed fit by surgeon

- Have measurable disease per Response Evaluation Criteria in Solid Tumors (RECIST) 1.1
criteria present

- Patients of child-bearing potential must agree to use adequate contraceptive methods
(e.g., hormonal or barrier method of birth control; abstinence) prior to study entry
and for the duration of study participation; should a woman become pregnant or
suspect she is pregnant while she or her partner is participating in this study, she
should inform her treating physician immediately

- Patient or legal representative must understand the investigational nature of this
study and sign an Independent Ethics Committee/Institutional Review Board approved
written informed consent form prior to receiving any study related procedure

Exclusion Criteria:

- Patients who have had chemotherapy or radiotherapy within 4 weeks (6 weeks for
nitrosoureas or mitomycin C) prior to entering the study or those who have not
recovered from adverse events due to agents administered more than 4 weeks earlier

- Uncontrolled intercurrent illness including, but not limited to, ongoing or active
infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac
arrhythmia, or psychiatric illness/social situations that would limit compliance with
study requirements

- Radiation to primary tumor prior to enrollment in this study

- Pregnant or nursing female patients

- Unwilling or unable to follow protocol requirements

- Any condition which in the Investigator's opinion deems the patient an unsuitable
candidate to receive treatment

- Received an investigational agent within 30 days prior to enrollment