Bladder Cancer Clinical Trial
Official title:
Ethacrynic Acid Elimination in Non-Muscle Invasive Bladder Cancer Patients Undergoing Transurethral Resection
Phase 1 study to provide quantitative characterization of the renal elimination of ethacrynic acid and metabolites in patients with non-muscle invasive bladder cancer (NMIBC) at the time of transurethral resection of bladder tumor
Bladder cancer continues to be a significant healthcare and financial liability in the United
States. Patients with Non-Muscle Invasive Bladder Cancer (NMIBC) are in desperate need for
both effective and easily tolerated treatment options. Current standard of care includes
immediate post-operative Mitomycin C (MMC), which decreases the rate of recurrence but does
not alter progression. Furthermore, in patients with high-grade NMIBC, standard of care
dictates that patients undergo intravesical Bacillus Calmette-Guerin (BCG) therapy. This
treatment has a high degree of morbidity with both local and systemic side effects along with
significant discomfort from treatment (intra-urethral catheterization and bladder
instillation). Our goal is to develop a bladder cancer treatment strategy designed to
decrease recurrence/progression rates in addition to decreasing the morbidity of treatment.
Twelve evaluable NMIBC patients will participate in this Phase 1 trial.
Treatment - patients will receive a single, 50 mg oral dose of ethacrynic acid administered
as two 25 mg strength EDECRIN® tablets immediately prior to transurethral resection of
bladder tumor.
Concentrations and excretion rates of ethacrynic acid in the urine, as well as of cysteine,
glutathione, and mercapturate metabolites, will be measured for each of 4 urine specimens
collected on the day of surgery (before, during, and at 2 timepoints after surgery).
Adverse events, serious adverse events, laboratory values, and vital sign measurements will
be collected.
Efficacy of ethacrynic acid treatment will be estimated by recording
recurrence/non-recurrence of disease at 3 months post-treatment
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