Open label, single arm, exploratory phase I clinical Trial to evaluate efficacy and safety of Mycobacterium w (Mw) in BCG refractory Superficial transitional cell carcinoma

Single arm Clinical trial of Mw(intradermal) in BCG refractory Superficial transitional cell carcinoma to study the efficacy and safety of Mw. Subjects with BCG refractory STCC meeting inclusion and exclusion criteria after transurethral resection will be screened and enrolled in this study. Eligible subjects will receive Mw intradermally every 14 days x 3 months and then monthly for 6 months thereafter once in two months for 6 months. Patients will be evaluated for response every 3 months by cystoscopy, cytology and bladder biopsy up to 15 months during study period. Expected time to finish the enrollment is 12 months & expected study duration is 27 months. Duration of subject participation is 15 months. Patients demonstrating a complete response will undergo close surveillance by cystoscopy, cytology and bladder biopsy. The surveillance schedule includes urine cytology, serial cystoscopies and biopsy of any suspicious mucosal lesions at every 3 months. Patients who will not respond will be recommended to undergo a radical cystectomy. Pretreatment studies will include an ECG and chest-x ray. Physical examination and assessment of toxicity will be performed before administration and during therapy. A CBC will be obtained at the end of the 12 week. A biochemistry panel examining liver enzymes and renal function will be performed at the beginning of study and during study. An evaluation under anesthesia with bladder biopsies will be performed at 12 weeks of therapy to assess for response. Intradermal treatment will be discontinued if the patient develops neutropenic fever (absolute granulocyte count < 1,000 cells/mL3 at the time of a documented temperature of 38 °C), documented bacteremia in the presence of neutropenia, grade 3 or 4 neutropenia or thrombocytopenia, bilirubin more than 1.5, or transaminases more than 3x normal. Treatment will be administered on an outpatient basis. No investigational or commercial agents or therapies other than those described above may be administered with the intent to treat the patient's malignancy.