The research study is being led at the University of Miami by principal investigator Mark L. Gonzalgo, M.D., Ph.D., a urologic oncologist at Sylvester, and professor and vice chairman of the Department of Urology at the Miller School. Sylvester, one of 30 sites in the U.S., is the only site in Florida currently enrolling patients in this trial.
Dr. Gonzalgo and his team are studying the safety, tolerance, and effectiveness of the ALT-803 agent, a cytokine-based immunotherapeutic investigational drug, for patients that have NMIBC, and have not responded to first-line treatment with BCG. Both medications are given in combination via a catheter as an intravesical therapy modality that flows directly into the bladder.
BCG stimulates the immune response system, and over time has proven to be a valuable agent in the treatment of bladder cancer, as well as an effective immunization for patients with tuberculosis. BCG is a standard treatment option for patients with NMIBC, however there is a global shortage of the medication due to the growing use and need for this product worldwide.
The clinical trial is a pathway for patients to receive BCG in addition to a new agent, ALT-803, to create a potentially better treatment plan and long-term positive outcomes. The use of ALT-803 gains more significance in lieu of the shortage of BCG by allowing patients access to this promising treatment.
For more information about the trial, contact Rody Barakat at (305) 243-2177 or Dr. Gonzalgo at (305) 243-3246.