A Phase I Trial to Determine the Safety, Tolerability and Maximum Tolerated Intravesical Dose of Aminophylline With BCG in Patients With Non-invasive Bladder Cancer
Before using the combination of BCG and aminophylline clinically, we need to first determine
if aminophylline is safe, when placed directly into the bladder of patients who have bladder
cancer. We will give it along with BCG (Bacillus Calmette-Guerin) - a medication put into
the bladder through a catheter tube to treat bladder cancer.
We also would like to determine the maximum dose of aminophylline that can be safely given
and how the drug is absorbed and used by the body as well as document side effects when
aminophylline is given in the bladder.
This is a study about aminophylline instilled into the bladder. Aminophylline has not been
proven to be safe or a helpful treatment for bladder cancer. It is considered an
experimental drug as used in this protocol for bladder cancer. Aminophylline has not been
given to anyone who has bladder cancer. Aminophylline is approved by the U.S. Food and Drug
Administration (FDA ) to give directly into the bloodstream for the treatment of asthma. We
intend to use it at doses much lower than that used for asthma.
Intervention Model: Single Group Assignment, Masking: Open Label
Dose limiting toxicity
Any cardiac arrythmia or seizure activity, > grade 2 allergic reactions, fever 101.5 for > 48 hours, > grade 1 insomnia, > grade 1 involuntary movements, > grade 2 nausea / vomiting, > grade 2 bladder spasms, dysuria or pelvic pain.
Tracy L Krupski, M.D.
University of Virginia
United States: Institutional Review Board
|University of Virginia Urology Department||Charlottesville, Virginia 22908|