| Exclusion Criteria: | 1) Patients who have had 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.
2) Patients may not be receiving any other investigational agents.
3) Patients with any metastatic disease of any kind.
4) History of allergic reactions attributed to compounds of similar chemical or biologic composition to SU011248/sunitinib malate.
5) NCI CTCAE grade 3 hemorrhage within 4 weeks of starting the study treatment.
6) History of or known brain metastases, spinal cord compression, or carcinomatous meningitis, or evidence of symptomatic brain or leptomeningeal disease on screening CT or MRI scan.
7) Any of the following within the 6 months prior to study drug administration: myocardial infarction, severe/unstable angina, coronary/peripheral artery bypass graft, symptomatic congestive heart failure, cerebrovascular accident or transient ischemic attack, or pulmonary embolism.
8) Ongoing cardiac dysrhythmias of NCI CTCAE grade >/= 2.
9) Prolonged QTc interval on baseline EKG >470ms.
10) Hypertension that cannot be controlled by medications (>140/90 mm Hg despite optimal medical therapy).
11) Pre-existing thyroid abnormality with thyroid function that cannot be maintained in the normal range with medication.
12) 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.
13) Pregnant women are excluded from this study because SU011248/sunitinib malate has the potential for teratogenic or abortifacient effects. Because there is an unknown but potential risk for adverse events in nursing infants secondary to treatment of the mother with SU011248/sunitinib malate, breastfeeding should be discontinued if the mother is treated with SU011248/sunitinib malate.
14) Known HIV-positive patients taking combination antiretroviral therapy are ineligible because of the potential for pharmacokinetic interactions with SU011248/sunitinib malate. Appropriate studies will be undertaken in patients receiving combination antiretroviral therapy when indicated. |