*NEW 3/3/25 – Autologous Cancer Vaccine with Checkpoint Inhibitor for Treatment of Canine Osteosarcoma (K9-ACV)

Ardent Clinical Trial Flyer

Ardent Consent Form

This study aims to evaluate the safety and efficacy of K9-ACV, an autologous killed tumor cell vaccine combined with a novel checkpoint inhibitor (CD200AR-L). This trial will compare K9-ACV to standard chemotherapy to treat canine appendicular osteosarcoma (OSA). By assessing K9-ACV, this trial seeks to advance safer, immune-based treatment options for canine cancer that may provide outcomes comparable to or superior to chemotherapy.

Patients enrolled in this trial will be randomly assigned to one of two groups at a ratio of 3:1 (for every 4 dogs entered, 1 will be randomized to the Standard of Care group, and 3 will be randomized to the IVP group): Standard of Care Group will receive the traditional Standard of Care (limb amputation plus chemotherapy). IVP Group will receive limb amputation followed by K9-ACV (limb amputation plus K9-ACV).

Fully Funded Trial for Dogs with Oral Melanoma

Trial Eligibility

• Weighs at least 3 kg (6.6 lbs)
• Diagnosis of Stage II or III oral melanoma (not confined to lip)
• Prior surgery acceptable (if performed at least 14 days prior to enrollment) if measurable disease remains which meets the criteria below
• If the target lesion was removed, regrowth of the lesion must have a longest diameter of ≥ 10 mm
• No lung metastasis
• No prior Oncept® melanoma vaccine
• Other study inclusion and exclusion criteria apply. The doctor will determine if the dog is a good candidate for this study after examination.

Requirements

• Patients will receive the novel investigational product or placebo intravenously every 2 weeks
• Patients and their owners are required to visit the clinic every 2 weeks for approximately 6 months
• Owners will be required to document study associated observations as appropriate.

Fully Funded Study Benefits

• Investigational product (dogs may have the option of enrolling in a follow-up study to receive investigational product, regardless of initial study treatment)
• Study-related examinations and diagnostics (thoracic radiographs)
• Lab work (CBC, blood chemistry, urinalysis)
• Owners will receive a $500 e-gift card if enrolled

For more information, please contact oncclinicaltrials@vetmed.wisc.edu or call 608-890-0422.

10/1/24 – FLASH Radiotherapy for Canine Osteosarcoma

FLASH flyer

FLASH radiation is defined as ultra-high dose rate radiation which has been shown in small animal and tissue models to spare normal tissues to a greater extent than normal radiation.

Any dog with suspect osteosarcoma on a limb will qualify.

1 treatment of radiation will be performed. Then your dog will be randomized to the FLASH group or the conventional radiation group for treatments. They will have 4 once/week follow up visits. If amputation is elected, it will be performed 1 month after the start of the study and the cost is covered by the study.

For more information, contact Dr. Tricia Hu at tghu@wisc.edu or Dr. Nathaniel Van Asselt at nvanasselt@wisc.edu or call 608-890-0422.

9/5/24 – Scout Out Canine Hemangiosarcoma (SOCH) Study

SOCH Clinical Trial Flyer

The UW Veterinary Cancer Center is currently accepting patients with hemangiosarcoma for a vaccine immunotherapy trial. The main objective of this trial is to assess the effectiveness and safety of incorporating an immune-stimulating vaccine alongside the standard of care (surgery and chemotherapy) for managing hemangiosarcoma in dogs. The aim is to activate the immune system to identify and destroy cancer cells.

Eligibility:
Dogs must weigh ≥5 kg (11 lbs).
Dogs must have a biopsy confirmed diagnosis of splenic hemangiosarcoma, stage I or II.
Dogs must have undergone a splenectomy within the 3 weeks preceding trial entry.
Other eligibility requirements are established at the first visit.

This fully funded study pays for the following:
All required examination visits
Lab work (CBC, blood chemistry, urinalysis)
Diagnostics every 8 weeks (thoracic radiographs and abdominal ultrasound)
Standard of care chemotherapy (Doxorubicin) x 5 cycles
The study does not pay for splenectomy, which is required for diagnosis

Half of the dogs will get standard-of-care + investigational anti-cancer vaccine, and the other half will get standard-of-care + placebo.

For more information and to request entry into this clinical trial, please get in touch with us at Email: oncclinicaltrials@vetmed.wisc.edu or Phone: (608) 890-0422

Dogs with Naive Lymphoma

Flyer

Laverdia CCNU Consent

Laverdia CCNU Schedule

We are enrolling dogs with a confirmed diagnosis of lymphoma that have not received other chemotherapy agents, immunosuppressants, or corticosteroids (prednisone). We are treating with a combination of Laverdia and CCNU to evaluate the safety and efficacy of different dosing protocols in the hopes of achieving better remission and survival times.

Clients need to pay all the costs associated with initial diagnosis. Once enrolled, the study pays for the treatment medications and recheck appointments, including labwork.

For more information, please contact our oncology service at 608-890-0422 or oncclinicaltrials@vetmed.wisc.edu.

Dogs with suspected limb osteosarcoma

FLASH Consent Form

The goal of this study is to investigate the effect of FLASH radiation on normal tissues in the dog. FLASH radiation is defined as an ultra-high dose rate delivery of radiation. Initial laboratory research has suggested that FLASH radiation is able to spare normal tissues to a greater extent than conventional radiation systems. We would like to test this in a controlled way by comparing FLASH radiation with a conventional radiation modality in the dog, which is a comparative model to a human. Skin response to radiation will be used for normal tissue assessment of radiation effect.

Dogs that have a high index of suspicion (metaphyseal lytic, proliferative monostotic bone lesion within the long bone of a mid to large breed dog) for diagnosis of appendicular osteosarcoma on presentation to UW Veterinary Care will be eligible for the study. Routine staging (chest radiographs, bloodwork, physical examination) will be optional and the owner will be responsible for the cost of staging. Dogs will still be eligible with the presence of pulmonary metastasis. Amputation will be performed at 4 weeks, and patients should be good amputation candidates prior to inclusion in the study. Tumors need to be located within 3-4 cm of the skin so they can be adequately treated with radiation.

For additional information, call 608-890-0422 or email oncclinicaltrials@vetmed.wisc.edu.

COTC 031: Evaluating Safety and Effectiveness of 45H1 (anti-CTLA-4), a novel anticancer agent, when given to dogs with B-cell Lymphoma

COTC031 Consent Form

This study is for dogs with histologically confirmed B-cell Lymphoma who are between 15-60 kg. Dogs can be newly diagnosed or relapsed. No concurrent chemotherapy or radiation therapy is permitted. Dogs must be off all such therapy for two (2) weeks prior to study enrollment. No treatment with corticosteroids or l-asparaginase is permitted for seven (7) days prior to study enrollment.

Most costs associated with this study will be provided as part of your participation. In the event, any complications arise from study drug administration, their management will be covered by study funds up to $2000/per event. This would include any unanticipated hospitalizations. Please discuss the study costs with your clinician.

Additionally, support will be provided after your dog’s completion of this study, in the form of a $1000 gift towards additional treatment for your dog’s cancer at UWVC.

For more information, please contact oncclinicaltrials@vetmed.wisc.edu or 608-890-0422.

COTC034: Evaluating Outcomes in Dogs with Limb Osteosarcoma Treated Palliatively with Amputation Alone

COTC034 Consent Form 02.05.24

The purpose of this study is to evaluate the outcomes for dogs treated palliatively with standard amputation (no chemotherapy). Recent data indicates that at least 35% of dogs do not appear to benefit from standard chemotherapy for this disease. To better understand whether chemotherapy is truly beneficial, this trial aims to document the outcomes prospectively and accurately for dogs whose owners have elected to treat only with surgery (amputation).

In order to enroll your pet to this trial:

· Your dog must be diagnosed with osteosarcoma

· Your dog must be equal to or more than 55 lbs.

If you allow your dog to participate in this study, you will be responsible for the cost of the initial examination with the UW Madison Oncology Service and all the screening diagnostic tests, which include a complete blood count (CBC), biochemistry profile, urinalysis, chest x-rays, and abdominal ultrasound. If your dog is found eligible, the amputation surgery will be paid for by the study. If you change your mind after surgery and choose to treat your dog with chemotherapy, do not attend follow up appointments, or otherwise withdraw your dog prior to week 15, you will be billed for all costs associated with surgery (typically around $5,500.00). Chest x-rays and routine 8-week follow up visits will be covered by the study up until 2-years. If your dog experiences adverse events related to the study, a total of $1000 will be allotted toward coverage of required care at UW Madison. In addition, you will receive a $500 credit towards palliative and comfort care that can be used here at UW Madison (oral medications etc.).

If your dog is determined to have another type of cancer other than osteosarcoma when the biopsy is processed after amputation, your dog will be removed from the trial, but the costs of surgery will still be covered by the study. For more information about possible costs, please contact oncclinicaltrials@vetmed.wisc.edu or 608-890-0422.

Looking for Cats with Large Cell Lymphoma

Pevonedistat feline flyer

We are evaluating the safety of a novel targeted drug Pevonedistat in cats with large cell lymphoma.
• Pevonedistat is a potent and selective injectable targeted therapy (NAE inhibitor) that has been studied in human lymphoma patients with minimal toxicities.
• Pevonedistat induces cancer cell death and tumor regression in canine lymphoma pre-clinical studies and made it a promising drug in treating feline large cell lymphoma, which is an aggressive disease without durable treatment response.

Aims:
• Primary aim: Determine the maximum tolerated dose, tolerability, and adverse event profile of Pevonedistat in cats diagnosed with large cell lymphoma
• Secondary aim: evaluate the pharmacokinetic profile of the drug and anti-tumor efficacy

Inclusion criteria:
• Cats diagnosed with large cell lymphoma via cytology or histopathology
• No chemotherapy or radiation therapy received within 2 weeks of enrollment
• No other major illness or blood work abnormalities that are expected to limit survival.

Methods:
• Cats will receive 3 subcutaneous injections of Pevonedistat (on Monday, Wednesday and Friday) in each 21-day cycle.
• Recheck appointments are required at the start of each treatment cycle and 1 week after injections (on day 12) including physical exam and blood exams. Urinalysis is required every 21 days (See details in table).
• Imaging exam (abdominal ultrasound or others depending on tumor location) are required on day 0 as baseline and day 42 to evaluate treatment response.
• study will pay for the cost of pevonedistat.
• Owners to cover costs of enrollment tests to confirm qualification and all the study diagnostic tests (with research discount) and recheck exam.

The UWVC Oncology service is evaluating the efficacy of a probiotic (Visbiome Vet®), compared to traditionally used metronidazole for the management of chemotherapy induced diarrhea in dogs with multicentric lymphoma receiving a 19-week CHOP chemotherapy protocol.Dogs with a confirmed diagnosis of multicentric lymphoma whose owners present to the UWVC oncology service for consultation and elect to treat their dog with 19-week CHOP protocol will be given the option to participate in the clinical trial. Dogs will be randomized into either the Visbiome® Vet or metronidazole treatment groups.

Owners of patients in both groups will be instructed to keep a diary once enrolled in the trial to monitor stool frequency, consistency, and schedule. Diet and medications will also be recorded; owners will be instructed to keep their dog’s diet consistent. Owners will start the respective diarrhea management medication once stools reach a fecal score of >4 (Fecal Scoring System, Nestle Purina PetCare Company, St. Louis, MO), or increased frequency or urgency from baseline is noted. The Fecal Scoring System will be provided for owners, and they will also be encouraged to take photos of their dogs’ eliminations. Stool samples will be collected at baseline/enrollment, prior to each doxorubicin administration, and 1 month after completion of chemotherapy. These samples will be analyzed in future research with consultation with the Gastrointestinal lab at Texas A&M University.

Owners will be financially responsible all costs associated with diagnosis of multicentric lymphoma and treatment with CHOP chemotherapy with the exception of recheck examination fees for timepoints associated with fecal sample collection, which will be covered by the study as client incentive. The cost of metronidazole or Visbiome® Vet (depending upon their randomized group) will be paid for by the study.

For further information or to enroll a potential patient, please contact oncclinicaltrials@vetmed.wisc.edu or call 608-890-0422.

Dogs with Histologically confirmed, high-grade lymphoma or non-sarcomatous solid tumors

This is a trial led by the National Cancer Institute (NCI) to assesses the safety and effectiveness of TdCyd and Aza-TdC, novel anticancer agents in dogs with cancer. This study will complement currently open human trials designed to test new doses and effects of these agents.

Prior to entry into this study, your dog must have a confirmed diagnosis of cancer and staging tests to ensure his/her general health and to evaluate how advanced the disease is prior to treatment. Costs to owner before confirming eligibility: $750-1000, depending on type of cancer and tests already done. These are routine staging costs and will be used to determine eligibility for the study.

Within this study, we will obtain serial biopsies of your dog’s tumor. A biopsy will be collected prior to the first dose of drug (pre-treatment), on Day 8, Day 12 and possibly on Day 22 depending on how your dog has responded to therapy. Each of these biopsy sessions will occur under sedation or general anesthesia. Your dog will return to the UW on Days 8, 12, 15 and 22. Serial blood collections (5 time points) will occur on Day 1 of the study. Subsequent, single collections will occur on Days 8, 12, 15 and 22. You will be required to administer study medication at home on Days 2, 3, 4, 5, 9, 10, and 11.  If any complications arise from study drug administration, their management will be covered by study funds.