The aim of the present study was to evaluate the efficacy of Ukrain as a new treatment modality in 28 patients with stage T1N0M0 bladder cancer. The tumor dimensions varied from 0.5 x 0.5 cm to 3 x 4 cm. The first group (nine patients) was treated with a total dose of 100 mg Ukrain, the second group (10 patients) received 200 mg Ukrain, and the third group (nine patients) was treated with 300 mg Ukrain. In all patients Ukrain was administered i.v. at a dose of 10 mg per day. In the patients from the second and third group each course of treatment, consisting of 10 injections, was followed by 14 days of no treatment. Ukrain, at a total dose from 100-300 mg as neoadjuvant therapy in patients with T1N0M0 bladder cancer, resulted in either complete or partial regression of tumors in 60.7 +/- 9.2% of cases. The best treatment regime included three courses of Ukrain at 2-week intervals.