Sunitinib Malate in Treating Patients With Recurrent Transitional Cell Bladder Cancer
Condition: Recurrent Bladder Cancer; Transitional Cell Carcinoma of the Bladder
MeSH terms: Carcinoma; Urinary Bladder Neoplasms; Carcinoma, Transitional Cell
Intervention: sunitinib malate; immunohistochemistry staining method; TdT-mediated dUTP nick end labeling assay; light microscopy; laboratory biomarker analysis
Intervention description: Given orally; Correlative studies; Correlative studies; Correlative studies; Correlative studies
Intervention MeSH terms: Sunitinib
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 19.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      RATIONALE: Sunitinib malate may stop the growth of tumor cells by blocking some of the
      enzymes needed for cell growth or by blocking blood flow to the tumor.

      PURPOSE: This phase II trial is studying how well sunitinib malate works in treating patients
      with recurrent transitional cell bladder cancer.
    

Eligibility 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)