A Phase I/II Study Assessing the Addition of Gemcitabine to BCG Treatment in People with High-Grade Non-Muscle Invasive Bladder Cancer that Returned after Prior BCG

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Full Title

Phase I/II Trial of Bacillus Calmette-Guérin (BCG) and Intravesical Gemcitabine for Patients with BCG-Relapsing High-Grade Non-Muscle Invasive Bladder Cancer

Purpose

Bacillus Calmette-Guerin (BCG) is a form of immunotherapy that is a standard treatment for patients with bladder cancer that has not grown beyond the lining of the bladder (non-muscle invasive bladder cancer). But sometimes the cancer continues to grow or comes back.

Gemcitabine is a common chemotherapy drug used to treat bladder cancer. Doctors want to know if adding gemcitabine to BCG therapy in these patients is an effective treatment, instead of trying BCG alone again. In this study, researchers are finding the highest dose of gemcitabine that can be given with BCG and looking to see how well it works in people with non-muscle invasive bladder cancer that has returned after prior BCG treatment. Both BCG and gemcitabine are given directly into the bladder.

Eligibility

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

  • Patients must have high-grade non-muscle invasive bladder cancer that came back within 2 years of the last BCG treatment.
  • Patients must be able to walk and do routine activities for more than half of their normal waking hours.
  • This study is for patients age 18 and older.

For more information and to inquire about eligibility for this study, please contact Dr. Eugene Pietzak at 646-422-4781.

Protocol

19-374

Phase

I/II

Disease Status

Relapsed or Refractory

Investigator