Pre-Surgical Sutent in Renal Cell Carcinoma (RCC)

The Study Drug:

Sunitinib malate is designed to block pathways that control important events such as the growth of blood vessels that are essential for the growth of cancer.

Study Treatment:

If you are found to be eligible to take part in this study, you will take sunitinib malate once a day (either with or without food) for 4 weeks in a row, followed by 2 weeks of rest with no study drug. These 6 weeks are considered 1 cycle of study treatment.

During Cycle 2, you will have surgery to remove the tumor. You will start taking sunitinib malate again after surgery (at least 14 days after surgery) on the same schedule as before.

Study Visits:

At the beginning of each new cycle (Cycles 1-6), you will have the following tests:

* Your complete medical history will be recorded. * You will have a physical exam, including measurement of your vital signs, and weight. * You will have a performance status evaluation. * You will be asked about any medicines you are currently taking and if you have experienced any side effects since your last visit. * You will have blood drawn (about 4 teaspoons) for routine testing. This blood will also be tested to check the function of your thyroid gland. * You will have follow-up scans (the same ones you had during screening to check the disease status) at the beginning of Cycle 2, after you have surgery, and at the beginning of each of the next 4 cycles. * You will have an ECG to measure the health of your heart.

Every 2 Cycles, you will have a follow-up echocardiogram or MUGA scan to check your heart function, if your doctor feels it is needed.

Beginning in Cycle 7, you will be asked to return to the clinic every other cycle (about every 12 weeks), unless your doctor thinks you should return more often. This means you would return for clinic visits at the start of Cycles 8, 10, 12, and so on, and may be asked to come back at other times.

At each visit, you will have the following tests:

* Your complete medical history will be recorded. * You will have a physical exam, including measurement of your vital signs and weight. * You will have a performance status evaluation. * You will be asked about any medicines you are currently taking and if you have experienced any side effects since your last visit. * You will have blood drawn (about 4 teaspoons) for routine testing at the beginning of each cycle. If you are scheduled to return to M. D. Anderson every 2 cycles (12 weeks), you may have the blood drawn for routine tests at your local doctor's office during the "non-visit" cycles. * You will have an ECG to measure the health of your heart. * You will have an echocardiogram or MUGA scan to check your heart function, if your doctor feels it is needed. * You will have follow-up scans (the same ones you had during screening to check the disease status).