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

• Status: Completed
• Trial end date: 2011-07-01
• Target enrollment: 0
• Participant gender: All

Summary

The purpose of this study is to determine the efficacy and safety of intravesical Mycobacterial Cell Wall-DNA Complex (MCC) in patients with non-muscle invasive transitional cell carcinoma (papillary tumors and/or carcinoma in situ) of the urinary bladder at high risk of progression who are refractory to therapy with bacillus Calmette-Guerin (BCG).

• Phase: Phase 2/Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Bioniche Life Sciences Inc.

Criteria

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.