Phase II Trial of Sunitinib Malate (Sutent) Therapy in Patients With Advanced Non-Clear Cell Renal Cell Carcinoma

Inclusion Criteria:

1. Patients must have histologically or cytologically confirmed advanced non-clear cell
of one of the following subtypes: papillary, chromophobe, collecting duct carcinoma
(CDC), renal medullary carcinoma (RMC), or unclassified. Patients with
conventional-type renal cell carcinoma who have >/= 20% sarcomatoid component in
their primary tumor are eligible. Patients who have sarcomatoid features in FNA or
core biopsy of any metastatic site are eligible.

2. Patients must have measurable disease.

3. ECOG performance status 0-1.

4. Patients must have adequate organ and marrow function within 14 days prior to study
entry as defined: Hemoglobin >/= 9 g/dl, absolute neutrophil count >/= 1,500/microL,
platelets >/= 100,000/microL, total bilirubin (SGPT) be dialysis).

5. Patients must have recovered from any effects of surgery.

6. Female patients of childbearing potential (not postmenopausal for at least 12 months
and not surgically sterile) must have a normal plasma beta human chorionic
gonadotropin (betaHCG) within 24 hours prior to enrolling in the study.

7. Patients of child fathering or childbearing potential must agree to practice a form
of medically acceptable birth control while on study (barrier method, hormonal
methods, etc.).

8. Patients must give written informed consent prior to initiation of therapy, in
keeping with the policies of the institution. Patients with a history of major
psychiatric illness must be judged (by the treating physician) able to fully
understand the investigational nature of the study and the risks associated with the
therapy.

9. Patients with brain metastases may participate in this trial.

10. Patients who have had up to two prior systemic therapies are eligible to participate
in this trial but they should not have had prior Multi-Tyrosine Kinase Inhibitors
such as sorafenib or sunitinib malate.

Exclusion Criteria:

1. No prior malignancy is allowed, except for non-melanoma skin cancer, in situ
carcinoma of any site, or other cancers for which the patient has been adequately
treated and disease free for 2 years.

2. Pregnant or lactating women are excluded.

3. Patients must not be scheduled to receive any experimental drug for MRCC while on
study. Patients are permitted to be on concomitant bisphosphonates. Patients are
permitted to receive hematopoietic growth factors according to ASCO guidelines.

4. Patients must not have had prior radiotherapy to areas of measurable disease, unless
they have clearly progressive disease in this site, or there is measurable disease
outside the area of prior radiation. Radiotherapy, if needed for palliation, must
have been completed at least 2 weeks prior to enrollment on this study.

5. Patients may not have any significant medical disease (other than the malignancy)
that, in the investigator's opinion, would increase the risk for participation.
Examples of exclusion: unstable angina pectoris, New York Heart Association (NYHA)
Grade II or greater congestive heart failure, unstable symptomatic cardiac
arrhythmias requiring medication (subjects with controlled chronic atrial
fibrillation are eligible), myocardial infarction within 6 months, uncontrolled HTN
(blood pressure >150/90 on therapy), QTc interval > 500msec or other significant ECG
abnormalities or uncontrolled DM.

6. Patients must not have history of other diseases, metabolic dysfunction, physical
examination finding, or clinical laboratory finding giving reasonable suspicion of a
disease or condition that contraindicates the use of sunitinib malate or that might
affect the interpretation of the results of the study or render the subject at high
risk from treatment complications.

7. Concomitant treatment with drugs with dysrhythmic potential (terfenadine, quinidine,
procainamide, disopyramide, sotalol, probucol, bepridil, haloperidol, risperidone,
and indapamide) is not recommended.

8. Patients unwilling to participate or unable to comply with the protocol for the
duration of the study.