Standard management for patients with high-risk bladder cancer that has not invaded the muscle and persists despite BCG therapy is removal of the bladder (cystectomy). There are a few drugs for patients who do not respond to intravesical BCG (giving the drug directly into the bladder through a small catheter), but they are associated with a low rate of cure.
The purpose of this study is to evaluate the safety and effectiveness of giving intravesical gemcitabine as well as oral everolimus to patients with high-risk non-muscle-invasive bladder cancer whose disease persists despite BCG therapy. Up to three doses of everolimus will be evaluated in the phase I portion of the study.
In a previous study, intravesical gemcitabine was shown to be effective in patients with high-risk non-muscle-invasive bladder cancer. However, the duration of response was short.
Everolimus is an oral drug that inhibits a molecule called mTOR, which helps cancer cells grow. Everolimus is approved for the treatment of renal cell carcinoma, but its use for treating bladder cancer is considered investigational.