Phase II Single Arm, Open Label, Single Institution Study of Continuous Sunitinib (Sutent) in Patients With High-Risk (BCG-Refractory) Superficial Transitional Cell Carcinoma (TCC) of the Bladder

Inclusion Criteria

Inclusion

- Patients must have clinically and histologically proven, recurrent superficial
transitional cell carcinoma of the bladder after treatment with BCG therapy

- Patients could have received previous any INTRAVESICAL therapy including BCG and/or
IFN and/or chemotherapy up to 3 years prior to registration

- Patients biopsy specimen should be available for review

- ECOG PS 0-1 (Karnofsky greater than 70%)

- Absolute neutrophil count >= 1,000/mcL

- Platelets >= 100,000/mcL

- Hemoglobin >= 8.5 g/dl

- Total bilirubin =< 1.5 X institutional upper limit of normal

- AST(SGOT)/ALT(SGPT) =< 3.5 X institutional upper limit of normal

- Alkaline phosphatase =< 2.5 ULN ( =< 10 x ULN in presence of bone metastasis)

- Serum calcium of =< 12 mg/dl

- Creatinine =< 1.5 X institutional upper limit of normal

- INR =< 1.5, except for subjects receiving warfarin therapy

- Eligibility of patients receiving any medications or substances known to affect or
with the potential to affect the activity or pharmacokinetics of Sunitinib (Sutent)
will be determined following review of their case by the Principal Investigator

- Women of child-bearing potential and men must agree to use adequate contraception
(hormonal or barrier method of birth control; abstinence) prior to study entry and
for the duration of study participation; sexually active patients must continue to
use contraception for three months after completion of study therapy; should a woman
become pregnant or suspect she is pregnant while participating in this study, she
should inform her treating physician immediately

- All patients must be informed of the investigational nature of this study and must
provide written informed consent in accordance with institutional and federal
guidelines

Exclusion

- Prior systemic chemotherapy for bladder cancer; all other systemic chemotherapy must
have been completed at least 3 years prior to enrollment

- Prior treatment with any other anti-angiogenic therapy (including immunomodulatory
agents such as thalidomide and lenalidomide, and anti-VEGF therapy with agents such
as bevacizumab (Bevacizumab Avastin, Sunitinib (Sutent) and Sorafenib (Nexavar)

- Prior major surgery (not TURBT/Cystoscopy), radiation therapy, or systemic therapy
within 4 weeks of starting the study treatment

- NCI CTCAE grade 3 hemorrhage within 4 weeks of starting study treatment

- 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

- Ongoing cardiac dysrhythmias of NCI CTCAE grade >= 2, or prolongation of the QTc
interval to > 450 msec for males or > 470 msec for females (Atrial Fibrillation is
allowed provided patients are rated controlled)

- Hypertension that cannot be controlled by medications

- Known human immunodeficiency virus (HIV) or acquired immunodeficiency syndrome
(AIDS) - related illness or infectious hepatitis type A, B or C

- Disease-free of prior malignancies for >= 2 years with exception of currently treated
basal cell, squamous cell carcinoma of the skin, or carcinoma in-situ of the cervix

- Other severe acute or chronic medical or psychiatric condition, or laboratory
abnormality that may increase the risk associated with study participation or study
drug administration, or may interfere with the interpretation of study results, and
in the judgment

- Pregnancy or breastfeeding (Female patients must be surgically sterile or
postmenopausal, or must agree to use effective contraception during the period of
therapy; all female patients with reproductive potential must have a negative
pregnancy test [serum or urine] prior to enrollment)

- Male patients must be surgically sterile or must agree to use effective contraception
during the period of therapy (The definition of effective contraception will be based
on the judgment of the principal investigator or a designated associate)