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GAIN-BCG: Gemcitabine Alternating with Intravesical BCG Randomized Against BCG Alone for Patients with Recurrent High Grade Non-Muscle Invasive Bladder Cancer

UCI Specialty Area: Cancer
Principal Investigator: Michael Daneshvar
A Study On:
Urinary Bladder

Study Description

This phase III trial compares the effect of adding gemcitabine to intravesical Bacillus Calmette Guerin (BCG) versus intravesical BCG alone in patients with non-muscle invasive bladder cancer that has come back after a period of improvement (recurrent). Gemcitabine is a chemotherapy drug that blocks the cells from making deoxyribonucleic acid (DNA) and may kill cancer cells. Intravesical BCG is a solution containing the live BCG bacteria that is placed in the bladder via a catheter (intravesical). When the solution comes into direct contact with the bladder wall, it stimulates the body's immune system which kills tumor cells. Giving gemcitabine with intravesical BCG may kill more tumor cells in patients with recurrent non-muscle invasive bladder cancer.

Eligibility

Inclusion Criteria:

  • Patients must have BCG-Exposed non muscle invasive bladder carcinoma (NMIBC), defined as recurrent high grade NMIBC within 24 months of last BCG exposure but not meeting the definition of BCG unresponsive disease
  • Prior treatment with any systemic or intravesical agents for NMIBC is allowed, regardless of whether it is given either alone or in prior combination with BCG (ie. Prior treatment with pembrolizumab, other immune checkpoint inhibitors, nadofaragene firadenovec, nogapendekin alfa inbakicept, cretostimogene grenadenorepvec, etc. are all allowed)
  • HIV-infected patients on effective anti-retroviral therapy with undetectable viral load within 6 months are eligible for this trial
  • Not pregnant and not nursing, Patient must not be pregnant or breast-feeding due to the potential harm to an unborn fetus and possible risk for adverse events in nursing infants with the treatment regimens being used.
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Privacy Policy

University of California, Irvine - Study Information Sheet

UCI Center for Clinical Research Potential Participant Database

Lead Researcher
Maheswari Senthil, MD
UCI Center for Clinical Research

In the instance of parental permission, “You” refers to “Your child.”

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