New Clinical Trial Opening for Dogs with Urinary Bladder Cancer in 2022

Background information:

  • The treatment for dogs with TCC has improved over several years, but better therapy approaches are still needed.
  • The new trial is for dogs with transitional cell carcinoma (TCC), also called urothelial carcinoma with the cancer in the bladder and/or the urethra, with or without cancer in other locations.
  • The goal is to determine how two drugs commonly used for TCC are stimulating anti-tumor immune responses, and how the sequence by which the drugs are given could improve treatment outcomes.
  • Dogs will first be treated with an intravenous chemotherapy drug called vinblastine given by itself. If the cancer becomes resistant and begins to grow, then the dogs will receive an oral drug called piroxicam by itself. Both drugs are generally well tolerated.
  • In previous studies when these two drugs were given sequentially one after the other, the median survival was ~7.5 months longer than when the drugs were given together at the same time. We want to confirm this benefit of sequential therapy.
  • The immune 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.

What are the eligibility requirements?

  • 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.
  • Only limited prior exposure to non-steroidal anti-inflammatory drugs (NSAIDs) such as piroxicam, Deramaxx (deracoxib), Metacam (meloxicam), Rimadyl (carprofen), Previocox (firocoxib), and others is allowed. 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 as 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 Purdue to enroll and undergo tumor staging and cystoscopy.
  • Evaluation includes blood test, ultrasound, x-rays, and cystoscopy. Cystoscopy is performed under general anesthesia.
  • After a month of vinblastine 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.
  • Vinblastine will be given intravenously at 2-week intervals, and blood counts (CBCs) will be performed weekly during vinblastine treatment. Vinblastine will continue as long as the cancer is controlled and the dog’s quality of life is good.
  • If resistance to vinblastine develops, and the tumor begins to grown, then piroxicam will be given orally by the pet owner, and the dog will continue to have monthly evaluations at Purdue.
  • 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.
  • A necropsy (autopsy) is requested at the time of the dog’s death (from any cause).

Financial support

  • 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 $400/month. 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.
  • The costs of other veterinary care that is not related to the cancer or cancer treatments in the study must also be covered by the pet owner.

What do I do to allow my dog to participate?

  • Case enrollment will be open starting in January 2022.
  • If you and your veterinarian would like for your dog to be evaluated for the trial, please ask your regular veterinarian to call the Purdue University Veterinary Hospital Oncology Service at (765)-494-1107 to refer the dog for an appointment.
  • That visit will allow us to determine if the trial is the best option for your 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.
  • Thank you!

 

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