Study of BCG + Aminophylline Toxicity When Used in the Treatment of Bladder Cancer (BCG)
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|ClinicalTrials.gov Identifier: NCT01240824|
Recruitment Status : Completed
First Posted : November 15, 2010
Last Update Posted : April 14, 2014
|Condition or disease||Intervention/treatment||Phase|
|Bladder Cancer||Drug: aminophylline||Early Phase 1|
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.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||3 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||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|
|Study Start Date :||July 2010|
|Actual Primary Completion Date :||February 2011|
|Actual Study Completion Date :||February 2011|
U.S. FDA Resources
Experimental: BCG + aminophylline
Bacillus Calmette-Guerin (BCG) plus one of three escalating doses of aminophylline administered intravesically.
One of three escalating doses of aminophylline (3 mg/kg, 6 mg/kg and 9 mg/kg) administered intravesically
- Dose limiting toxicity [ Time Frame: Week 6 ]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.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01240824
|United States, Virginia|
|University of Virginia Urology Department|
|Charlottesville, Virginia, United States, 22908|
|Principal Investigator:||Tracy L Krupski, M.D.||University of Virginia|