Lead Sponsor

Eli Lilly and Company

Age

18 - No limit years

Sex

ALL

Healthy Volunteers

No

•Clinical evidence of superficial transitional cell carcinoma of the bladder
•Males or females at least 18 years of age
•Karnofsky Performance Status greater than or equal to 70%
•Patient compliance and geographic proximity that allow adequate follow-up
•Female patients with reproductive potential must use a reliable contraceptive method if appropriate (for example, intrauterine device \[IUD\], birth control pills, or barrier device) during the study. Female patients with reproductive potential must have a negative serum pregnancy test within 7 days of study enrollment.
•Signed informed consent.

•Clinical evidence of muscle-invasive or locally advanced bladder cancer
•Clinical evidence of upper urinary tract tumor
•Distant metastases
•Other malignancies within the last 2 years, except non-melanotic skin tumors, carcinoma in situ of the cervix or organ-confined prostate cancer after curative therapy
•Severe concomitant psychiatric disease
•Febrile, active infection
•Other serious concomitant disorders that would compromise the safety of the patient or his/her ability to complete the study according to the protocol, at the discretion of the investigator (for example, unstable angina pectoris, uncontrolled diabetes mellitus)

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