Urinary Bladder Cancer Trial

Urinary bladder cancer, and specifically invasive transitional cell carcinoma or "TCC" or "InvTCC" in dogs, is an ongoing focus of research in the Werling Comparative Oncology Research Center. This cancer is also referred to as urothelial carcinoma, although we often use the term “TCC” since that is the term many pet owners look for.

Information learned from pet dogs with TCC is expected to help the individual dog, other dogs with the same type of cancer, and potentially humans with invasive bladder cancer.

The goal of a new study is to determine how drugs in two different classes can stimulate the immune system to attack TCC in dogs. Both of the drugs in the trial are already proven to be beneficial in dogs with TCC and are part of “standard care” for the cancer. We are also interested in the sequence by which the drugs are given. There is increasing evidence from our studies that if we can learn the optimal sequence of drugs, that this will improve survival. The advantages of a dog participating in the trial are: the dogs will receive drugs that are part of “standard” TCC therapy at a much lower cost, and at the same time, we learn important information about how sequencing these drugs matters, and how to harness the dog’s immune system to attack the cancer, therefore improving therapy for dogs and humans in the future.

Background

The treatment for dogs with TCC has improved over several years, but better therapy approaches are still needed.
This trial will help us exploit the immune enhancing effects of drugs for TCC to make therapy more successful.
This new trial is for dogs with transitional cell carcinoma (TCC) in the bladder and/or the urethra, with or without cancer in other locations.
Dogs will first be treated with an oral drug called piroxicam. If the cancer becomes resistant and begins to grow, then the dogs will receive an intravenous drug called vinblastine. Both drugs are generally well tolerated.
The immune cell infiltration in the tumor will be measured in tumor tissue samples collected with an instrument called a cystoscope before and during therapy.
By understanding how these drugs enhance the immune response, we can develop better strategies to apply them in combination with other therapies to treat TCC more effectively.
Because invasive TCC in dogs is so similar to muscle invasive bladder cancer in humans, this new knowledge will help dogs and people facing invasive TCC.

Eligibility for Dogs to Participate in the Study

Informed dog owner consent in writing.
Good general health of the dog, and serum creatinine (a measure of kidney function) <2.0 mg/dl.
Confirmed diagnosis of TCC or the presence of a bladder and/or urethral mass with strong suspicion for TCC.
No prior chemotherapy or radiation therapy is allowed.
Prior exposure to non-steroidal anti-inflammatory drugs (NSAIDs) such as piroxicam, Deramaxx (deracoxib), Metacam (meloxicam), Rimadyl (carprofen), Previcox (firocoxib), and other NSAIDs must be limited. NSAIDs are not allowed during the trial unless directed by the study team.
No current supplements including vitamins, herbs, CBD products, “immune health” products, and other supplements are allowed. Supplements are not allowed during the trial because these can reduce the efficacy of the therapy.

What is involved for the dog/dog owner?

The dog will have a 2-day visit at the Purdue Veterinary Hospital to enroll and undergo tumor staging and cystoscopy.
Evaluation includes blood test, ultrasound, x-rays, and cystoscopy. Cystoscopy is performed under general anesthesia.
The dog will then receive an oral medication, piroxicam, given once daily by the pet owner at home.
After a month of piroxicam treatment, the dog will have another 2-day visit at Purdue for evaluation and a second cystoscopy.
After the second visit, the dog will continue to be checked monthly at Purdue with those visits expected to take a full day.
Piroxicam treatment will continue as long as the tumor is controlled and the drug is well-tolerated.
If resistance to piroxicam develops and the tumor begins to grow, then an intravenous medication, vinblastine, will be given intravenously at 2-week intervals. Complete blood counts (CBCs) will be performed weekly during vinblastine treatment. Vinblastine treatment will continue as long as the cancer is controlled and the dog’s quality of life is good.
If the cancer develops resistance to both drugs, the dogs can go off study and will be eligible for other therapies. The expenses for treatments given off study will be covered by the dog owner.

Financial Support

The study will cover all costs at Purdue from enrollment through the second cystoscopy visit, i.e. the visit after a month of piroxicam and the second cystoscopy. After that, the total out-of-pocket cost paid by the pet owner for all study-related diagnostic testing and treatments performed at the Purdue University Veterinary Hospital will be $250 per month while the dog receives piroxicam alone, and $400 per month when vinblastine is added. The remainder of the expenses at Purdue will be covered by the Purdue study.
It is acceptable for some of the vinblastine treatments to be given by the dog’s regular veterinarian and to have the weekly CBCs performed by the primary care veterinarian, but these expenses must be covered by the pet owner.

What do I do to allow my dog to participate?

Pet owners and veterinarians that are interested in the trial, or who would like more information, or have questions please contact our Clinical Trials Nurse, Lindsey Fourez at 765-494-1130 or lfourez@purdue.edu. Please leave a message for a call back.
We recommend scheduling an appointment for evaluation here at Purdue. That visit will allow us to determine if the trial is the best option for the dog, and if the dog is eligible. If we determine that the trial is not the best option, we can assist with other treatments too.

Questions

Please call the Purdue University Veterinary Hospital Oncology Service at 765-494-1107.