College of Veterinary Medicine
Knapp with Scotty

Urinary Bladder Cancer Trial

Urinary bladder cancer, specifically invasive transitional cell carcinoma (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 tend to use the most common term that pet owners are familiar with, TCC.

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 muscle invasive bladder cancer.

The goal of this study is to determine the antitumor effects of a new drug to treat TCC. Briefly, veterinarians in the WCORC work closely with scientists in the Purdue Institute for Cancer Research (PICR), an organization on campus focused on eradicating human cancer. One of the PICR scientists, Dr. Majid Kazemian, has used a unique type of computer modeling to learn new ways to attack cancer at the molecular level. His work has identified a new drug which is expected to cause remission in patients with TCC. The new drug is called enitociclib and it is a type of drug called a CDK9 inhibitor. Our goal is to determine how effective this drug is in dogs with TCC. This is the first study of its kind as this type of medication (CDK9 inhibitor) is a brand new approach to treating TCC.

The advantages for the pet participating in the trial is that they will receive a new drug that is expected to work well against TCC and at a lower cost than other treatments. Simultaneously, our team will learn important information about how to better treat TCC in dogs and in humans.

 

Background

  • The treatment for dogs with TCC has improved over several years, but better therapy approaches are still needed.
  • This trial will help us determine how well the new treatment strategy will work.
  • This new trial is for dogs with TCC in the bladder and/or the urethra, with or without cancer in other locations.
  • The new drug, enitociclib, is given by an intravenous treatment at weekly intervals. The dogs must come to Purdue for each treatment.
  • To determine how well the drug is working at the molecular level, a sample of the TCC tissue will be collected through a scope before and after a month of treatment.
  • Because invasive TCC in canines 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

  • Good general health of the dog, serum creatinine (a measure of kidney function) <2.0 mg/dl, and serum alanine amino transferase (a liver chemical) < 138 U/L.
  • Confirmed diagnosis of TCC or the presence of a bladder and/or urethral mass with strong suspicion for TCC with the diagnosis to be confirmed during the study.
  • No prior radiation therapy is allowed.
  • A “washout” period is required if the dog has received prior chemotherapy to allow time for the drug to eliminate from the dog’s body.
  • Previous use of nonsteroidal anti-inflammatory drugs (NSAIDs) will be allowed in selected circumstances.
  • No current supplements including vitamins, herbs, CBD products, “immune health” products, or other supplements are allowed. Supplements are not allowed during the trial because these can reduce the efficacy of the therapy, or make the dog sick.

 

What is involved for the dog/dog owner?

  • At the beginning, the dog will have an extended, 2-day visit at the Purdue Veterinary Hospital to enroll in the trial. Diagnostic staging and blood tests will be done to determine the extent of the cancer. Then, a cystoscopy is performed to collect a sample, or biopsy, of the cancerous tissue.
  • Evaluation includes blood tests, ultrasound, x-rays, and cystoscopy. Cystoscopy is performed under general anesthesia.
  • The treatment involves an intravenous infusion given at weekly intervals. The first and fourth treatment will consist of an extended, 2 day visit at the hospital. For other treatment days will be considered outpatient, where the pet arrives that morning and will leave with the owner the same afternoon.
  • After the second visit, the dog will continue to receive the CDK9 inhibitor for as long as the cancer is controlled and as long as the dog feels well.
  • If the cancer begins to grow in the face of the CDK9 inhibitor treatment, then the pet can go "off study" and will be eligible for other therapies. The expenses for treatments given off study will have to be covered by the dog owner.
  • The new drug is expected to be well tolerated, but side effects such as low blood counts or stomach upset are possible. The drug dosage will be adjusted if these occur, or the dog can go off study and receive other therapies.
  • Although we hope each dog will live a long time with good quality of life, we know each dog will reach the end of their life eventually. The dog owner is asked to allow a necropsy when their dog dies whether the death is due to cancer or some other condition. Examining the tumor tissues after the dog has died is beneficial in helping us understand how the new drug worked at the molecular/cell signaling level, and how to make it work even better.

 

Financial Support

  • The dog owner is required to pay $300 per month to defray the expenses related to the study treatment and diagnostic tests to monitor the tumor response that are performed at Purdue.
  • The remainder of the expenses incurred at Purdue including those related to the treatment, monitoring the response to the treatment, and managing any potential side effects if they occur will be covered by the Purdue study.
  • It is expected that the treatments and monitoring will be performed at Purdue. Any visits to the regular veterinarian, should those occur, must be paid for by the dog owner. Similarly, any veterinary care that is not related to the cancer or the cancer treatment must be covered by the dog owner.

 

How can my dog participate?

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

 

Questions

Call the Purdue University Veterinary Hospital at 765-494-1107 to schedule an appointment (referral required from referring DVM) or call 765-494-1130 to reach the Clinical Trial nurses.