Urinary Bladder Cancer Trial

Urinary bladder cancer, medically termed as invasive urothelial carcinoma (InvUC) or transitional cell carcinoma (TCC), is a serious form of cancer. It can lead to blockage of urine flow and secondary organ dysfunction caused by the spread of cancer. Although most dogs with TCC initially respond favorably to treatment, the cancer often becomes resistant to treatment over time and recurs, or grows back again. This is why we are studying ways to improve bladder cancer treatment. This cancer is an ongoing focus of research in the Werling Comparative Oncology Research Center.

Any new information we learn from dogs with TCC will help current and future dogs that develop this type of cancer. Additionally, canine TCC is very similar to muscle invasive bladder cancer in people. Our studies have been able to translate to human research efforts to help those affected by this type of cancer as well.

Two studies are open for dogs with TCC: (1) an immunotherapy trial with a therapeutic canine PD-L1 monoclonal antibody, and (2) a trial for a targeted drug, a CDK9 inhibitor. All of our trials are approved by the Purdue Animal Care and Use Committee.

Immunotherapy Trial with a Therapeutic Canine PD-L1 Monoclonal Antibody in Dogs

Principal Investigator

Dr. Deborah Knapp, Distinguished Professor of Comparative Oncology; Dolores L. McCall Professor of Comparative Oncology; Director, Evan and Sue Ann Werling Comparative Oncology Research Center

Background

The goal of this study is to determine the anticancer effects of a new immunotherapy drug in dogs with TCC. This immunotherapy is classified as an "immune checkpoint inhibitor." Immune checkpoint inhibitors have had dramatic anticancer effects in human cancer patients. Jimmy Carter, for example, benefited from a drug in this class to eradicate his metastatic melanoma several years ago. We anticipate that immune checkpoint inhibitors can help dogs with cancer as well.

The immune checkpoint inhibitor we are evaluating is a monoclonal antibody to a protein called PD-L1. It is given by an intravenous infusion at 2-week intervals. This canine PD-L1 antibody, which we will refer to as the “cPD-L1 mAb”, was developed at Purdue University.

The advantages of trial participation is that the pet will receive a new drug that is expected to help fight thier cancer at a discounted cost compared to other therapies.

Eligibility For Dogs to Participate in the Study

Good general health and a serum creatinine (a measure of kidney function) <2.0 mg/dl.
Biopsy-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 leave 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 and increase risk of side effects. A 2-week washout period is required between the last supplements given and enrollment in the trial.

What is involved for the dog/dog owner?

To start participating in the trial, the dog will have a 2-day visit at the Purdue Veterinary Hospital to enroll in the trial and have initial tests to confirm the dog’s health status and extent of the cancer. The tests will include blood and urine tests, imaging with x-rays and ultrasound, and a bladder scoping (cystoscopy) to collect small samples of the cancer to confirm the diagnosis and assess immune cells in the cancer. Cystoscopy is performed under general anesthesia.
The dog will return the next week to start the cPD-L1 mAb treatment. The dog will stay a full day and overnight in the hospital for the first treatment. The first 6 dogs enrolled will also need to provide blood samples at 1, 2, 3, and 7 days after the first treatment.
The cPD-L1 mAb is given as an intravenous infusion, and treatments will continue at 2-week intervals. Each treatment will require the dog to be in the hospital all day.
At the time of the third treatment, the cystoscopy will be repeated. This visit will take 2-3 days at the Purdue Veterinary Hospital.
There is no limit to the number of cPD-L1 mAb doses the dog can receive. As long as the cancer is controlled and the pet feels well they can continue to receive the treatments.
If the dog’s cancer begins to grow again with the cPD-L1 mAb treatment or if the dog develops major side effects, they would go “off study” and could receive other types of therapy. After going off study, the owner resumes responsibility to pay full price for the recommended therapies.
We hope each dog will live a long time with a good quality of life. Ultimately, we realize each dog will reach the end of their life eventually. The dog owner is asked to give consent to a necropsy when their dog passes, whether the death is due to the cancer or an unrelated condition. Examining the cancer tissues is extremely beneficial in helping us understand how this drug worked at the molecular level, how it affected the immune system, and how we can 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 cancer response that are performed at Purdue.
The remainder of the expenses incurred at Purdue including those related to the treatment, monitoring the response to treatment, and managing any potential side effects if they occur will be covered by Purdue.
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.

Trial Status

Actively Recruiting

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. This 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.

CDK9 Inhibitor Trial in Dogs

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.