This trial is designed to evaluate the safety and preliminary pain management and effect of a novel therapy in dogs with bladder transitional cell carcinoma (TCC). A secondary goal is to assess potential anti-cancer effect. The trial involves one-time treatment administered directly into the bladder using a urinary catheter. Dogs may receive a second treatment one month after enrollment if warranted. The treatment will be administered under sedation or general anesthesia. There is no placebo in this trial. An estimated 15 client-owned dogs with will be enrolled. Owners will be required to complete quality of life surveys, collect a daily urine sample for visual analysis, and record the urine collection results in a provided journal. The trial site will train the owners on collection and evaluation techniques. Trial visits include the dog’s initial consultation, treatment day (Day 0), and then recheck visits on Days 7, 14, 28, 56, and 84. Anti-cancer therapies must be discontinued 21 days prior to enrollment. Medications targeted at the treatment of TCC-associated pain, except for CBD and other cannabinoids, are acceptable provided they have been administered for at least 2 weeks prior to enrolling in the study.
The trial is fully funded for the full trial duration (84 days). Funding includes the initial consultation, the study treatment and administration, thoracic radiographs at the beginning and end of the study, monthly abdominal ultrasounds, recheck visits, trial-required bloodwork, and management of side effects that are thought to be directly related to the trial.
Trained veterinarians at the trial sites will evaluate each dog for eligibility.
Dogs are eligible if they meet the following inclusion criteria:
- Dog presenting with a diagnosis of TCC exclusively associated with the bladder (metastasis is acceptable).
- Dog with accompanying lower urinary tract clinical signs associated with bladder cancer.
- Bladder lesion does not prevent the passage of urinary catheter.
Dogs are not eligible if they meet any of the following exclusion criteria:
- Dog with urethral or prostatic involvement of TCC.
- Dog has any underlying disease that will affect the study objectives or patient safety.
- Dog has evidence of hydronephrosis.
- Dog has an active urinary tract infection (dogs presenting for screening will have a urine culture performed prior to enrollment).
- Dog has a urethral obstruction.
- Dog is pregnant or lactating.
- Dog is participating in another study.
This clinical trial is offered at the following locations:
Hope Veterinary Specialists
40 Three Tun Road
Malvern, PA 19355
Las Vegas Veterinary Specialty Center
8650 W. Tropicana Avenue, Ste. B-107
Las Vegas, NV 89147
BluePearl Specialty and Emergency
11950 West 110th St
Overland Park, KS 66210
The Oncology Service – Dogwood
5918 West Broad St
Richmond, VA 23230
The Veterinary Cancer Center
129 Glover Ave, Norwalk
Norwalk, CT 06850