Status:
COMPLETED
Study of BCG + Aminophylline Toxicity When Used in the Treatment of Bladder Cancer
Lead Sponsor:
University of Virginia
Conditions:
Bladder Cancer
Eligibility:
All Genders
40+ years
Phase:
EARLY_PHASE1
Brief Summary
The purpose of this study is to evaluate whether a new potential treatment for non invasive bladder cancer is safe and if it leads to side effects such as irregular heart rate, agitation, or burning w...
Detailed Description
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 wil...
Eligibility Criteria
Inclusion
- Male or female \> 40 years of age because in patients younger than that the natural history is different.
- Histologically proven bladder cancer that is NOT muscle invasive (Ta or T1)
- Transurethral resection of Bladder Tumor (TURBT) at least 2 weeks prior to first instillation
- ECOG performance status of 0 or 1.
- Informed consent obtained from patient before enrollment.
- English is primary language
- Patients undergoing initial 6 week BCG therapy (BCG naïve)
- Patients undergoing 3 week BCG maintenance therapy.
Exclusion
- Hypersensitivity reaction or contraindication to aminophylline or theophylline
- Pregnancy (confirmed by a serum human chorionic gonadotropin pregnancy test) or breast feeding).
- Hepatic insufficiency as defined by an abnormal AST or ALT.
- Known arrhythmias or heart failure as defined by class II or greater cardiovascular disease according to the New York Heart Associations functional criteria
- Immunocompromised
- Seizure disorder.
- Current treatment with oral theophylline or any other methylxanthine derivative.
- Active urinary tract infection by nitrite positive urine dip or gross hematuria
- Reduced dosing of BCG or BCG failures who have experienced bladder cancer recurrrence.
Key Trial Info
Start Date :
July 1 2010
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
February 1 2011
Estimated Enrollment :
3 Patients enrolled
Trial Details
Trial ID
NCT01240824
Start Date
July 1 2010
End Date
February 1 2011
Last Update
April 14 2014
Active Locations (1)
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1
University of Virginia Urology Department
Charlottesville, Virginia, United States, 22908