A Phase I/II Study of Everolimus and Intravesical Gemcitabine in BCG-Refractory Primary or Secondary Non-Muscle-Invasive Bladder Cancer

Protocol
10-165
Full Title
Phase I/II Study of RAD001 and Intravesical Gemcitabine in BCG-Refractory Primary or Secondary Carcinoma In Situ of the Bladder
Phase
I/II
Purpose

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.

Eligibility

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

  • Patients must have a confirmed diagnosis of high-risk non-muscle-invasive bladder cancer that persists despite BCG therapy.
  • At least 4 weeks must have passed since completion of prior therapy and entry into the study, and patients must have recovered from any side effects.
  • Patients may not have received prior treatment with an mTOR inhibitor (everolimus, temsirolimus, or sirolimus).
  • Patients must be age 18 or older.

For more information about this study and to inquire about eligibility, please contact Dr. Guido Dalbagni at 646-422-4394.

Disease(s)
Bladder Cancer
Locations
Related Diseases

Cancer Clinical Trials: Personalizing for Each Patient

Join our experts for a discussion of clinical trials on November 18. Clinical trials can give patients access to new drugs and other treatments before they are widely available, but how do you know if a trial is right for you?

Learn more »