Markers of Response to Intravesical Bladder Cancer Therapy
In this study, researchers are looking at markers that they could use to identify - at an
early time point - those patients who might not respond to this treatment. This would allow
researchers to provide future patients with information about their chances of responding to
such treatment. And, with this information, researchers could better counsel those patients
who might benefit from a different therapy at an earlier time point.
Treatment with BCG or BCG plus interferon is currently the most effective nonsurgical
treatment for superficial bladder cancer. However, at this time, there is no reliable test
that can help researchers predict which patients will respond to this therapy. You will be
receiving BCG or BCG plus interferon therapy as planned by your physician. This is a
standard therapy that will be decided by your doctor and based on your disease
characteristics. If you agree to take part in this study, your participation will not
affect the treatment you will receive in any way. Your follow-up and disease monitoring will
be done according to standard routines.
By participating in this study, you agree to provide researchers with 4 tablespoons (or as
much as you can produce) of urine at the following time points.
1. Before you start therapy.
2. Just before and 4 hours after your last treatment (which usually occurs 6 weeks after
start of treatment).
3. Just before and 4 hours after your last treatment of the second course of therapy
(which is usually about 3 months after the beginning of the first course of therapy.
In addition, you will provide researchers with a bladder wash sample. This sample will be
collected during routine catheterization (for your planned treatment) or during your routine
cystoscopic exam. Bladder wash samples will be collected at the following time points.
1. Before you start therapy.
2. Just before your last treatment (which usually occurs 6 weeks after start of
3. At your first routine cystoscopic follow-up (which usually occurs at 3 months).
4. At your second routine cystoscopic follow-up (which usually occurs at 6 months).
Your follow-up cystoscopies and maintenance therapy will be done according to routine care
as decided by your doctor and are not affected by your participation in this study. You
will be part of the study for about 24 months after beginning the treatments. At the end of
that period, between 23 and 27 months, you will be checked with cystoscopy and cytology to
see if the tumor has come back, as part of standard of care.
In addition, information will be collected from your medical chart about other medications
that you are taking and other conditions, such as diabetes or heart disease, that you may
have. Information will also be collected about previous treatment that you have had for
bladder cancer as well as other treatments that you may receive during this study. This may
include treatments that are received at an outside health facility. Neither your name nor
your medical record number will be kept with this information. All of the information
collected for this study will be kept in a locked cabinet to which only the researchers have
access. Upon completion of the study, the information sheets will be destroyed.
This is an investigational study.
A total of 300 patients will take part in this study. All will be enrolled at MD Anderson.
Observational Model: Case-Only, Time Perspective: Prospective
Number of Patients with Clinical tumor recurrence or progression by 24 months after initiation of intravesical immunotherapy
Baseline to 24 months
Ashish M. Kamat, MD
UT MD Anderson Cancer Center
United States: Institutional Review Board
|UT MD Anderson Cancer Center||Houston, Texas 77030|