Study of BCG + Aminophylline Toxicity When Used in the Treatment of Bladder Cancer
| Status: | Completed |
|---|---|
| Conditions: | Cancer, Cancer, Bladder Cancer |
| Therapuetic Areas: | Oncology |
| Healthy: | No |
| Age Range: | 40 - Any |
| Updated: | 5/3/2014 |
| Start Date: | July 2010 |
| End Date: | December 2014 |
| Contact: | M. Elaine Woodson |
| Email: | mew3u@virginia.edu |
| Phone: | 434-982-3704 |
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
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.
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.
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.
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.
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