Mycobacterial Cell Wall-DNA Complex in Treatment of BCG-refractory Patients With Non-muscle Invasive Bladder Cancer

Inclusion Criteria:

* Patients refractory to BCG therapy;
* Patients with histologically confirmed diagnosis of high grade lesions;
* Diagnosis of high grade lesion must be within 56 days prior to beginning of study treatment;
* Have had all visible papillary lesion(s) resected by TURBT within 56 days prior to beginning of study treatment;
* Available for the whole duration of the study including follow-up (60 months);
* Life expectancy of \> 5 years;
* Patients with an ECOG performance status grade of 2 or less;
* Absence of urothelial carcinoma involving the upper urinary tract or prostatic urethra within 12 months from beginning of study treatment;
* Able to understand and give written informed consent;
* In the investigator's judgment, the patient is able to participate in the study.

Exclusion Criteria:

* Current or previous history of muscle invasive tumors;
* Current or previous history of lymph node or distant metastases from bladder cancer;
* Current systemic cancer therapy;
* Current or prior pelvic external beam radiotherapy;
* Pelvic brachytherapy within 2 years of study entry;
* Prior treatment with MCC;
* Patients with existing urinary tract infection or recurrent severe bacterial cystitis;
* Clinically significant and unexplained elevations of liver or renal function tests;
* White blood cell count below 3 x109/L (3,000/mm3) or platelet count below 100 x 109/L(100,000/mm3);
* Severe cardiovascular disease;
* Women who are pregnant or lactating;
* Congenital or acquired immune deficiency;
* With history of malignancy of any organ system, treated or untreated, within the past 5 years (with the exception of adequately treated basal cell or squamous cell carcinoma of the skin, stage T1 prostate cancer, carcinoma in situ of the cervix or colon polyps);
* Previous investigational treatment within 3 months from beginning of study treatment;
* Patients who cannot hold the instillation for one hour;
* Patients who cannot tolerate intravesical administration or intravesical surgical manipulation (cystoscopy or biopsy);
* Clinically significant active infections;
* Any medical or psychiatric condition which, in the opinion of the investigator, would preclude the participant from adhering to the protocol or completing the trial per protocol.