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

Recruiting in Palo Alto (17 mi)

+30 other locations

Overseen by Alvaro Morales, MD

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 2 & 3

Waitlist Available

Sponsor: Bioniche Life Sciences Inc.

No Placebo Group

Prior Safety Data

Trial Summary

What is the purpose of this trial?

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).

Research Team

Alvaro Morales, MD

Principal Investigator

Centre for Applied Urological Research, Kingston General Hospital/Queen's University

Eligibility 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;

Treatment Details

Interventions

• Mycobacterial cell wall-DNA complex (Cancer Vaccine)

Participant Groups

Group I: Mycobacterial cell wall-DNA complex Experimental Treatment 1 Intervention

Mycobacterial cell wall-DNA complex

Who Is Running the Clinical Trial?

Bioniche Life Sciences Inc.

Lead Sponsor

Trials

3

Recruited

210+