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
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.
Investigator
Co-Investigators
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
ClinicalTrials.gov
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