Trial Information

Open-label, Multi-center Study of the Efficacy and Safety of MCC in the Treatment of Patients With Non-muscle Invasive (Superficial) Bladder Cancer at High Risk of Progression and Who Are Refractory to BCG

The study will be divided into 3 phases: Induction, Maintenance, and Follow-up.

The Induction Phase will cover a period of 6 weeks. During this time, patients will receive
6 weekly intravesical instillations of 8 mg MCC. The patients will be evaluated at month 3,
at which time the patients will enter the Maintenance Phase. The Maintenance Phase will last
from month 3 to month 24, and during this time, patients will receive weekly MCC
instillations for three weeks at months 3, 6, 12, 18, and 24 and evaluations will be
performed at months 3, 6, 9, 12, 15, 18, 21 and 24.

At month 3, the patient will be evaluated to assure that the disease is not progressing.
Cytology, cystoscopy and biopsies will be performed to obtain adequate staging (if residual
tumor persists). If the patient is disease-free, maintenance therapy will be initiated.
Patients with non-muscle invasive tumors at month 3 will, at the discretion of the
investigator, receive either a second 6-week induction course or a 3-week maintenance
course. Patients who show progression to muscle invasive disease will be referred to other
treatments.

At month 6 and thereafter at each evaluation visit, patients will be evaluated and managed
according to the following results:

- Patients who are disease-free will continue on maintenance treatment.

- Patients who are not disease-free (evidence of papillary lesions, CIS or muscle
invasive disease) will be withdrawn from further study treatment and will be referred
to other therapies at the discretion of the investigator.

The final 36 months of the study is the Follow-up Phase. Evaluations will be performed at
months 30, 36, 42, 48, 54 and 60.

Efficacy evaluations will include standard cystoscopy, biopsies and urine cytology. During
the Maintenance Phase, standard cystoscopies will be performed at months 3, 6, 9, 12, 15,
18, 21 and 24 for the surveillance of bladder tumors. During the months that instillations
will be performed, cystoscopies will be conducted only once at each of these months. During
the Follow-up Phase, cystoscopies will be performed at months 30, 36, 42, 48, 54 and 60.

Mandatory bladder biopsies will be done for all patients at month 6.

During the course of the study, biopsies will be taken only if evident or suspicious lesions
are seen during cystoscopy or in case of negative cystoscopy but positive cytology.