Seeking Dogs for Enrollment in a Clinical Trial Evaluating an Investigational Agent for Management of Transitional Cell Carcinoma
Dec 12, 2018
This trial is designed to evaluate the safety and preliminary pain management and anti-cancer effectiveness of a novel therapy in dogs with bladder transitional cell carcinoma (TCC). The trial involves one-time procedure administered directly into the bladder using a urinary catheter. Dogs may receive a second infusion one month after enrollment if warranted. The infusion 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, day of administration (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 investigational agent 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 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.