Radiosurgery in Treating Patients With Kidney Tumors

OBJECTIVES:

Primary

- To evaluate and compare the clinical safety of utilizing four different schemes of
radiosurgical ablative techniques for treating poor surgical candidates with renal
tumors.

Secondary

- To evaluate and compare the clinical and radiographic efficacy of four different schemes
of radiosurgical ablation of renal tumors in poor surgical candidates.

Serum Blood Marker Objective:

- To determine if serum markers collected before and after radiation may give a predictive
indication of tumor response.

OUTLINE: This is a phase I, dose-escalation study followed by a phase II study.

Patients undergo placement of 2-3 fiducial markers in or near the renal tumor. Patients then
undergo 4 fractions of stereotactic radiosurgery in the absence of disease progression or
unacceptable toxicity. Treatment may repeat at 6 months if tumor is still present.

After radio-surgery, follow-up will be done at 1 , 3 and 6 months and then every 6 months
post radiosurgery for a total of 36 months.

PROJECTED ACCRUAL: A total of 32 patients will be accrued for this study.

Inclusion Criteria:

- Patient is considered a poor surgical candidate for removal of renal mass as
determined by anesthesiology pre-operative assessment or the surgical team, medical
team. (No major psychiatric illnesses.)

- Patient is able to give and sign study specific informed consent

- No prior radiation to the treatment field

- Negative serum or urine pregnancy test within 72 hours prior to registration for women
of childbearing potential

- Patient has a radiologically and /or pathologically confirmed diagnosis of a renal
tumor

- Karnofsky status of ≥ 60%

- Signed study-specific informed consent prior to study entry

Exclusion Criteria:

- Any patient not meeting the eligibility criteria.

- Any patient with active connective tissue disease such as lupus, dermatomyositis.

- Any patient with active Crohn's disease or active ulcerative colitis.

- Major psychiatric illness, which would prevent completion of treatment or interfere
with follow-up.