Myeloid Derived Suppressor Cells Clinical Assay in Finding Kidney Cancer

PRIMARY OBJECTIVES:

I. To evaluate a novel clinical assay (Myeloid Derived Suppressor Cells [MDSC] Clinical
Assay) to detect cancer associated immune cells in the peripheral blood of patients as a
means to better detect and monitor malignant renal cell carcinoma in patients.

II. Determine mean MDSC level, intra-subject variability, and inter-subject variability for
three groups of subjects with variable renal cell carcinoma disease status at baseline.

III. In patients with known localized renal cell carcinoma who undergo nephrectomy, determine
the change in MDSC level from diagnosis to after nephrectomy.

IV. In patients with known metastatic renal cell carcinoma who undergo systemic treatment,
determine the change in MDSC level from baseline to after treatment (4 months) and,
secondarily, to compare these changes to the changes in tumor burden as evaluated by computed
tomography (CT) scan or other imaging modality.

OUTLINE: Patients are assigned to 1 of 3 groups according to disease status.

GROUP I: Patients with no evidence of cancer and no hematuria undergo collection of blood and
urine samples at baseline and 2 months for analysis via the Flow Cytometry MDSC Clinical
Assay.

GROUP II: Patients diagnosed with localized renal cell carcinoma undergo collection of blood
and urine samples at baseline and after nephrectomy for analysis via the Flow Cytometry MDSC
Clinical Assay. Patients also undergo CT or magnetic resonance imaging (MRI) within 30 days
after nephrectomy.

GROUP III: Patients diagnosed with metastatic renal cell carcinoma undergo collection of
samples prior to baseline and then after 4 months of systemic treatment for analysis via the
Flow Cytometry MDSC Clinical Assay. Patients also undergo CT or MRI after completion of 4
months of systemic treatment.

Inclusion Criteria:

- Subjects enrolled in this study must meet one of the 3 following criteria:

- Group 1: Healthy individual with no history of cancer or hematuria

- Group 2: Subject with a diagnosis of localized renal cell carcinoma (by imaging
and eventual pathology) scheduled to undergo nephrectomy

- Group 3: Subject with a diagnosis of metastatic renal cell cancer(by imaging and
eventual pathology) who is scheduled to begin a new systemic therapy

- Any type of renal cell carcinoma (RCC); any prior therapy

- Performance status: 0-3

- Leukocytes >= 3,000/mcL (frequently used - numbers listed are examples, investigator
should modify as needed)

- Absolute neutrophil count >= 1,500/mcL (frequently used - numbers listed are examples,
investigator should modify as needed)

- Ability to understand and the willingness to sign a written informed consent

Exclusion Criteria:

- For normal subject arm: no evidence of cancer or hematuria

- For localized RCC arm: no evidence of metastatic disease, second cancer, prior
chemotherapy or radiotherapy within 4 weeks prior to entering the study or those who
have not recovered from adverse events due to agents administered more than 4 weeks
earlier

- For metastatic RCC arm: no evidence of second cancer, prior chemotherapy or
radiotherapy within 4 weeks prior to entering the study or those who have not
recovered from adverse events due to agents administered more than 4 weeks earlier

- For all subjects: uncontrolled intercurrent illness including, but not limited to
previous or current history of second malignancy unrelated to renal cell carcinoma;
autoimmune disease or immune deficiency, chronic treatment with immunomodulatory
therapies (e.g. glucocorticoids); significant trauma, surgery, or infection in the
past two weeks or psychiatric illness/social situations that would limit compliance
with study requirements