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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
Sponsor:
Information provided by (Responsible Party):
University of Virginia

Tracking Information
First Submitted Date  ICMJE November 11, 2010
First Posted Date  ICMJE November 15, 2010
Last Update Posted Date April 14, 2014
Study Start Date  ICMJE July 2010
Actual Primary Completion Date February 2011   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: November 12, 2010)
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.
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT01240824 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Study of BCG + Aminophylline Toxicity When Used in the Treatment of Bladder Cancer
Official Title  ICMJE 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
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.
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.

Study Type  ICMJE Interventional
Study Phase  ICMJE Early Phase 1
Study Design  ICMJE Intervention Model: Single Group Assignment
Masking: None (Open Label)
Condition  ICMJE Bladder Cancer
Intervention  ICMJE Drug: aminophylline
One of three escalating doses of aminophylline (3 mg/kg, 6 mg/kg and 9 mg/kg) administered intravesically
Study Arms  ICMJE Experimental: BCG + aminophylline
Bacillus Calmette-Guerin (BCG) plus one of three escalating doses of aminophylline administered intravesically.
Intervention: Drug: aminophylline
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: April 10, 2014)
3
Original Estimated Enrollment  ICMJE
 (submitted: November 12, 2010)
15
Actual Study Completion Date  ICMJE February 2011
Actual Primary Completion Date February 2011   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 40 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01240824
Other Study ID Numbers  ICMJE 14585
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party University of Virginia
Study Sponsor  ICMJE University of Virginia
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Tracy L Krupski, M.D. University of Virginia
PRS Account University of Virginia
Verification Date April 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP