SIU Med School Is Exclusive Site for Bladder Cancer Clinical Trial
Combined Drug Therapies May Prevent Need for Surgery
A new clinical trial for bladder cancer has opened exclusively at Southern Illinois University School of Medicine in Springfield. The trial will combine the current use of drug therapy placed inside the bladder with a new, intravenous drug that increases the response of the immune system. The study will determine if the combination of the two drugs is safe and potentially be more effective at eliminating the cancer cells. The new drug, pembrolizumab, may fight the disease and prevent the need for surgery.
Dr. Shaheen Alanee, assistant professor at Southern Illinois University School of Medicine, head of urologic oncology and a member of Simmons Cancer Institute (SCI) at SIU, said the trial is for aggressive, high-risk superficial bladder cancer that has not invaded the muscle of the wall of the bladder. Patients eligible for the clinical trial continue to have the disease despite previous treatment. “These patients have limited options for therapy other than surgery,”Alanee said. “No good medical therapy exists for patients who fail initial treatment, and that is what made us think of this regimen.”
Fifteen to twenty patients will be enrolled in the trial. Study participants will be treated with pembrolizumab before other treatments begin. Pembrolizumab will continue for six weeks during the course of traditional treatment and stopped several weeks after the BCG regimen is finished.
Patients will receive treatment over the course of four months. Study follow up will monitor progression of the disease or for two years following completion of the treatment, whichever occurs first.
About 50,000 cases of bladder cancer are diagnosed in the United States every year. Presently, if a patient has a recurrence of bladder cancer, the options for therapy are very limited besides surgery. The surgery entails removing the bladder and connecting the kidneys to the outside using a segment of the small bowel. “If the trial is successful, patients could be spared a major surgery with a very high risk of complications.”