Single Dose Intravesical Apaziquone Postoperative in Patients Undergoing TURBT for Noninvasive Bladder Cancer (SPI-611)

Inclusion Criteria: (All questions must be answered YES)

• Has the patient given written informed consent?
• Is the patient at least 18 years old?
• Does the patient have transitional cell carcinoma of the bladder with clinicallyapparent stage Ta, grade G1-G2?
• If the patient is a female of childbearing potential, is she using anacceptable/effective method of contraception?
• If the patient is a female of childbearing potential, has she had a negative serumpregnancy test within the past 14 days?
• Is the patient willing and able to abide by the protocol?

Exclusion Criteria: (All questions must be answered NO)

• Does the patient have more than 4 bladder tumors?
• Does any single bladder tumor exceed 3.5 cm in diameter?
• Does the patient have a single, primary (no previous diagnosis of TCC) bladder tumor <0.5 cm?
• Has the patient ever received Apaziquone?
• Does the patient have, or has the patient ever had, any bladder tumor known to beother than stage Ta or grade G1 or G2 (low grade [WHO/ISUP classification])?
• Does the patient have, or has the patient ever had any bladder tumor with histologyother than transitional cell carcinoma?
• Does the patient have, or has the patient ever had, carcinoma in situ (CIS)?
• Does the patient have an active urinary tract infection?
• Does the patient have a bleeding disorder or a screening platelet count < 100 x 10^9/L?
• Does the patient have any unstable medical condition that would make it unsafe forhim/her to undergo TURBT under general or spinal anesthesia?
• Does the patient have a screening hemoglobin < 10 mg/dL, a screening absoluteneutrophil count < 1.5 x 10^9/L or a screening creatinine > 2 mg/dL?
• Does the patient have a known immunodeficiency disorder?
• Has the patient received any investigational treatment within the past 30 days?
• Is the patient breast feeding?
• Does the patient have a history of interstitial cystitis?
• Does the patient have a history of allergy to red color food dye?
• Has the patient had transitional cell carcinoma of the bladder within the past 4months?