A Phase 3 Study Assessing BCG Therapy With and Without Gemcitabine in People With Non-Muscle Invasive Bladder Cancer That Came Back After Prior BCG

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Full Title

GAIN-BCG: Gemcitabine Alternating with INtravesical BCG Randomized Against BCG Alone for Patients with Recurrent High Grade Non-Muscle Invasive Bladder Cancer (A032303) (CIRB)

Purpose

Bacillus Calmette Guerin (BCG) is standard therapy for people with bladder cancer that has not grown into the muscle wall. It is given intravesically (directly into the bladder) and stimulates the immune system to kill cancer cells. But sometimes the cancer comes back.

Researchers want to see if gemcitabine plus BCG is better than BCG alone for people with bladder cancer that returned. Gemcitabine is a chemotherapy drug that directly kills cancer cells. It is a standard bladder cancer therapy that is given intravesically, with minimal side effects.  

The people in this study have non-muscle invasive bladder cancer that came back after prior BCG. Doctors hope that gemcitabine plus BCG will prevent cancer from coming back in people with recurrent non-muscle invasive bladder cancer.

If you take part in this study, you will be randomly assigned to get one of these treatments:

  • BCG alone
  • Gemcitabine plus BCG.

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Who Can Join

To join this study, there are a few conditions. You must:

  • Have non-muscle invasive bladder cancer that came back within 2 years of prior BCG therapy.
  • Be age 18 or older.

Contact

For more information or to see if you can join this study, please call Dr. Eugene Pietzak’s office at 646-422-4781.

Protocol

25-158

Phase

Phase III (phase 3)

Disease Status

Relapsed or Refractory

Investigator

Co-Investigators

ClinicalTrials.gov ID

NCT07000084