A Phase III Study Comparing Two Different Versions of BCG Therapy into the Bladder as well as BCG Vaccination in Patients with High-Grade Non-Muscle Invasive Bladder Cancer

Full Title

A Phase III Randomized Trial to Evaluate the Influence of BCG Strain Differences and T Cell Priming with Intradermal BCG Before Intravesical Therapy for BCG-Naive High-Grade Non-Muscle Invasive Bladder Cancer (SWOG S1602)(CIRB)

Purpose

Bacillus Calmette-Guerin (BCG) is a commonly used treatment for people with bladder cancer that has not invaded the muscles of the bladder wall. It is given directly into the bladder (intravesical therapy) and stimulates the immune system to fight bladder cancer. In this study, researchers are comparing a new version of BCG therapy to the standard version. They also want to see if giving BCG vaccination enhances the effects of treatment.

Patients in this study will be randomly assigned to receive standard intravesical BCG therapy, the new intravesical BCG therapy, or vaccination with the new BCG strain before the new intravesical therapy.

Eligibility

To be eligible for this study, patients must meet several criteria, including but not limited to the following:

  • Patients must have high-grade bladder cancer that has not invaded the muscular part of the bladder wall nor metastasized to other parts of the body.
  • Patients must have had visible bladder tumors removed.
  • Patients may not have previously received BCG therapy.
  • This study is for patients age 18 and older.

For more information and to inquire about eligibility for this study, please contact Dr. Bernard Bochner at 646-422-4387.

Protocol

17-492

Phase

III

Disease Status

Newly Diagnosed

Investigator

Co-Investigators