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

This is an interventional treatment trial for Bladder Neoplasms focused on measuring Bladder neoplasm, Intravesical drug administration, Neoplasm recurrence, local, Transitional cell, carcinoma, Carcinoma in situ, Mycobacterium Read More

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.