Study of BCG + Aminophylline Toxicity When Used in the Treatment of Bladder Cancer

Completed · Early Phase 1

Conditions studied: Bladder Cancer

In brief

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 with urination. Patients who have early stage bladder cancer and will be receiving BCG, a bladder cancer therapy as recommended by a doctor, will be asked to participate in a study where they are given the standard BCG followed by the experimental drug, aminophylline. Although we hope this medicine may one day prove to help bladder cancer patients, at the current time we do not know if it has any benefits at all. We have data in mice that suggest that aminophylline slows the growth of tumors when coupled with BCG.

Key facts

Study ID

NCT01240824

Run by

University of Virginia

People needed

3

Starts

2010-07-01

Expected to finish

2011-02-01

Last updated by the study team

2014-04-14

Who can join

Age: 40 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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.

Where it is running

• University of Virginia Urology Department — Charlottesville, Virginia, United States

Full record on ClinicalTrials.gov

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