Mycobacterial Cell Wall-DNA Complex in Treatment of BCG-refractory Patients With Non-muscle Invas… (NCT00406068) | Clinical Trial Compass
CompletedPhase 2/3
Mycobacterial Cell Wall-DNA Complex in Treatment of BCG-refractory Patients With Non-muscle Invasive Bladder Cancer
United States129 participantsStarted 2006-11
Plain-language 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).
Who can participate
Age range18 Years
SexALL
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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 o…