Intravesical AD 32 (Valrubicin) in Patients With Carcinoma in Situ (CIS) of the Bladder Who Have Failed or Have Recurrence Following Treatment With Bacillus Calmette-Guerin (BCG)

Inclusion Criteria

Inclusion-

1. Patients must have pathologically-proven CIS with no evidence of muscle invasive
disease.

2. Patients with concurrent Ta or T1 papillary tumors are eligible provided papillary
tumor(s) are resected prior to study treatment. Cystoscopic evaluation and, if
indicated, transurethral resection of bladder tumor (TURBT) must be performed within
28 days of study treatment.

3. Patients must have received at least two or more prior courses of intravesical
therapy for CIS per the recommended schedules. BCG must have been one of the prior
therapies administered. Patients can have either failed BCG therapy or have been
successfully treated with BCG, but subsequently found to have recurrence. The
standard course of intravesical therapy must include six weekly treatments (allowable
range of instillations per course is 4-9).

4. Patients must have a positive urine cytology at baseline (<28 days) prior to the
first AD 32 (valrubicin) treatment. Patients with papillary lesions must have a
positive cytology following TURBT or have a baseline cytology that was negative or
equivocal and histologic confirmation of CIS.

5. Patients must have an ECOG performance status of 0-2 and a life expectancy of at
least 6 months.

Exclusion-

1. Patients with urogenital tumors with histology other than transitional cell carcinoma

2. Patients with residual papillary disease at the time of study treatment.

3. Patients with a history of other primary malignancy (other than squamous or basal
cell skin cancers) within the last 5 years.

4. Patients with evidence of muscle invasive disease (stage higher than T1).

5. Patients with any previous intravesical treatment with AD 32 (valrubicin).

6. Patients with any intravesical therapy within 28 days prior to first AD 32
(valrubicin) treatment.

7. Patients with a plan to receive other concurrent therapy for treatment of primary
treatment tumor during participation in this study.

8. Patients who had received prior systemic or radiation therapy for bladder cancer.

9. Women who were pregnant or lactating. Individuals of reproductive potential could not
participate unless agreeing to use an effective contraceptive method for themselves
and/or their sexual partners.

10. Patients who, in the investigator's opinion, could not comply with the provisions of
the protocol or did not understand the nature of the study.

11. Patients who, in the opinion of the investigator, could not tolerate intravesical
administration of approximately 75 mL of fluid or who could not tolerate surgical
manipulation (cystoscopy, mapping biopsies, barbotage) due to the presence of
concomitant serious illnesses (ie, uncontrolled cardiac or respiratory disorders).