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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01240824
Recruitment Status : Completed
First Posted : November 15, 2010
Last Update Posted : April 14, 2014
Information provided by (Responsible Party):
University of Virginia

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 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.

Condition or disease Intervention/treatment Phase
Bladder Cancer Drug: aminophylline Early Phase 1

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 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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 3 participants
Allocation: N/A
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

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Bladder Cancer

Arm Intervention/treatment
Experimental: BCG + aminophylline
Bacillus Calmette-Guerin (BCG) plus one of three escalating doses of aminophylline administered intravesically.
Drug: aminophylline
One of three escalating doses of aminophylline (3 mg/kg, 6 mg/kg and 9 mg/kg) administered intravesically

Primary Outcome Measures :
  1. 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.

Information from the National Library of Medicine

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Ages Eligible for Study:   40 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  1. Male or female > 40 years of age because in patients younger than that the natural history is different.
  2. Histologically proven bladder cancer that is NOT muscle invasive (Ta or T1)
  3. Transurethral resection of Bladder Tumor (TURBT) at least 2 weeks prior to first instillation
  4. ECOG performance status of 0 or 1.
  5. Informed consent obtained from patient before enrollment.
  6. English is primary language
  7. Patients undergoing initial 6 week BCG therapy (BCG naïve)
  8. Patients undergoing 3 week BCG maintenance therapy.

Exclusion Criteria:

  1. Hypersensitivity reaction or contraindication to aminophylline or theophylline
  2. Pregnancy (confirmed by a serum human chorionic gonadotropin pregnancy test) or breast feeding).
  3. Hepatic insufficiency as defined by an abnormal AST or ALT.
  4. Known arrhythmias or heart failure as defined by class II or greater cardiovascular disease according to the New York Heart Associations functional criteria
  5. Immunocompromised
  6. Seizure disorder.
  7. Current treatment with oral theophylline or any other methylxanthine derivative.
  8. Active urinary tract infection by nitrite positive urine dip or gross hematuria
  9. Reduced dosing of BCG or BCG failures who have experienced bladder cancer recurrrence.

Information from the National Library of Medicine

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 identifier (NCT number): NCT01240824

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United States, Virginia
University of Virginia Urology Department
Charlottesville, Virginia, United States, 22908
Sponsors and Collaborators
University of Virginia
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Principal Investigator: Tracy L Krupski, M.D. University of Virginia
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Responsible Party: University of Virginia Identifier: NCT01240824    
Other Study ID Numbers: 14585
First Posted: November 15, 2010    Key Record Dates
Last Update Posted: April 14, 2014
Last Verified: April 2014
Keywords provided by University of Virginia:
bladder cancer
urothelial carcinoma
transitional cell carcinoma bladder
Additional relevant MeSH terms:
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Urinary Bladder Neoplasms
Urologic Neoplasms
Urogenital Neoplasms
Neoplasms by Site
Urinary Bladder Diseases
Urologic Diseases
Bronchodilator Agents
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Anti-Asthmatic Agents
Respiratory System Agents
Cardiotonic Agents
Phosphodiesterase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Purinergic P1 Receptor Antagonists
Purinergic Antagonists
Purinergic Agents
Neurotransmitter Agents
Protective Agents