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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


Phase 0
40 Years
N/A
Open (Enrolling)
Both
Bladder Cancer

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Trial Information

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


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.


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.

Type of Study:

Interventional

Study Design:

Intervention Model: Single Group Assignment, Masking: Open Label

Outcome Measure:

Dose limiting toxicity

Outcome Description:

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.

Outcome Time Frame:

Week 6

Safety Issue:

Yes

Principal Investigator

Tracy L Krupski, M.D.

Investigator Role:

Principal Investigator

Investigator Affiliation:

University of Virginia

Authority:

United States: Institutional Review Board

Study ID:

14585

NCT ID:

NCT01240824

Start Date:

July 2010

Completion Date:

December 2014

Related Keywords:

  • Bladder Cancer
  • bladder cancer
  • urothelial carcinoma
  • transitional cell carcinoma bladder
  • ureter
  • Urinary Bladder Neoplasms

Name

Location
University of Virginia Urology Department Charlottesville, Virginia  22908