Phase II Study to Evaluate the Efficacy and Tolerability of Intravesical Vicinium™ in Patients With Non-Invasive Urothelial Carcinoma in Situ (CIS) Previously Treated With Bacille Calmette-Guérin (BCG)

Inclusion Criteria:

Disease Characteristics

- The patient must be male or female 18 years of age or older.

- The patient must have histologically-confirmed Transitional Cell Carcinoma (TCC) of
the bladder.

- The patient must have histologically-confirmed carcinoma in situ (CIS), with or
without non-invasive papillary disease

- The patient must have immunohistochemically-confirmed EpCAM positive disease.

- The patient must have a life expectancy of at least 12 months.

Prior/Concurrent Therapy

- The patient must have, within the last 24 months, failed to respond to at least 1
cycle of treatment with BCG (with or without interferon) or be intolerant to BCG
treatment.

- The patient must have had a transurethral resection of the bladder tumour (TURBT)
mapping the location of tumour and quantifying the area of bladder affected.

- The patient must have documented residual CIS (i.e. unresectable disease) prior to
study drug administration.

Patient Characteristics

The patient must have adequate organ function, as defined by the clinical trial protocol

Other

- The patient must have the ability to understand and sign an Independent Ethics
Committee or Institutional Review Board (IEC/IRB)- approved informed consent document
indicating that the patient (or legally acceptable representative) has been informed
of all the pertinent aspects of the trial prior to enrollment and is willing and able
to comply with scheduled visits, treatment plan, laboratory tests, and other study
procedures.

Exclusion Criteria:

- The patient has evidence of urethral or upper tract transitional cell carcinoma (TCC)
by biopsy or upper tract radiological imaging (i.e. intravenous pyelogram, computed
tomography (CT) urogram, or retrograde pyelogram) within the past 2 years

- The patient has hydronephrosis

- The patient has had prior intravesical chemotherapy or investigational or anti-cancer
treatments within the last 2 months, inclusive of single-dose adjuvant intravesical
chemotherapy immediately post-TURBT

- The patient has existing severe urinary tract infection or recurrent severe bacterial
cystitis

- The patient has active, uncontrolled impairment of the renal, hepatobiliary,
cardiovascular, gastrointestinal, urogenital, neurologic or hematopoietic systems
which, in the opinion of the investigator, would predispose the patient to the
development of complications from the administration of intravesical therapy and/or
general anesthesia

- Any patient who, in the opinion of the investigator, cannot tolerate intravesical
administration or intravesical surgical manipulation (cystoscopy, biopsy) due to the
presence of concomitant serious illness (i.e. uncontrolled cardiac or respiratory
disorders)

- The patient is pregnant or breast feeding

- Women of reproductive age (who are not either medically or surgically incapable or
bearing children) and all men may not participate unless agreeing to use double
barrier contraception, or commit to abstinence during the period of therapy