A Phase 1/2a Pilot Study of Intravesical TSD-001 for Treatment of Low-Grade, Stage Ta, Non-Muscle Invasive Bladder Cancer

Protocol: 
AAAR2604
Phase: 
I/II

A Phase 1/2a Pilot Study of Intravesical TSD-001 for Treatment of Low-Grade, Stage Ta, Non-Muscle Invasive Bladder Cancer

The purpose of this study is to look at a new treatment for non-muscle-
invasive bladder cancer. This new form of paclitaxel, a drug currently used
by injection into a vein to treat various types of cancer, is designed to be
instilled (injected) into the urinary bladder with a catheter (tube) placed
into your bladder through your urethra (the opening where your urine comes
out), which is about a five-minute office procedure. The catheter is then
removed and you are observed in the office for 2 hours. This is an
investigational product, which means that it is not approved for bladder
injection by the Food and Drug Administration (FDA). Other formulations of
paclitaxel are approved by the FDA for intravenous administration, including
Taxol and Abraxane.
This research is being done because paclitaxel instilled directly into your
bladder (intravesical therapy) may provide a more effective method to reduce
bladder cancer recurrence and progression. As noted above, the words
“instilled” and “instillation” refer to the act of injecting the study drug
into your bladder through your urethra.
If you participate in this study, you will have all but one bladder tumor
removed from the bladder during endoscopic surgical resection. This
procedure is called Transurethral Resection of Bladder Tumor (TURBT). The
tumor not removed is called the marker lesion, and it must be less than 2 cm
(about 3/4 of an inch) in size and appear non-invasive. Over 1000 study
subjects have been enrolled in marker lesion studies, and no cases of
bladder tumor progression have been reported. After the removal of all but
the marker lesion, you will receive weekly bladder instillation of TSD-001
for 6 total treatments. A cystoscopy (a procedure in which a thin tube with
a camera and light on the end is inserted through your urethra and into your
bladder so the doctor can examine the inside of your bladder) is part of the
standard of care during bladder tumor follow-up. Six to 8 weeks after
completion of the investigational weekly intravesical therapy (TSD-001), a
biopsy of the tumor area (and removal of any visible tumor) will also be
performed at the time of the cystoscopy to ensure that no residual tumor

Are you Eligible? (Inclusion Criteria)

1. 18 to 85 years of age at time of study enrollment.
2. Able to meet the requirements of the study, give voluntary, written
informed consent, and
must be able to adhere to dosing and visit schedules.
3. Has a diagnosis of low-grade (G1 or G2), uni- or multifocal papillary-
appearing bladder
tumor, stage Ta.

Specialty Area(s)

Trial Location

Herbert Irving Comprehensive Cancer Center
161 Fort Washington Ave.
Herbert Irving Pavilion
New York, NY 10032
United States