Melanoma clinical trials for dogs.

CALIFORNIA
Study #1: OMX-4.80 (Zox) a novel protein oxygen transporter and radiation sensitizer for dogs with oral
melanoma
Location: University of California Veterinary Hospital Davis, CA
Contact: Teri Guerrero at tguerrero@ucdavis.edu or 1-530-752-0125
www.vetmed.ucdavis.edu/clinicaltrials/current_trials/by_species/dogs.cfm

For a study flyer, click here.

Rationale:
One reason tumors can be resistant to radiation therapy because of low levels of oxygen in the tumors. Another reason is
that low levels of oxygen leads to local immune suppression. We anticipate that the treatment will carry oxygen to the tumor
and hopefully restore normal oxygen levels to the tumor and make it more responsive to treatment.

Eligibility:
Dogs diagnosed with a biopsy confirmed melanoma.

Procedures:
It is important to note that radiotherapy treatments are being done as part of the normal treatment of this disease. If your
dog is enrolled in the study, the following will be done:

On Day 1, On Day 1, we will administer a drug to mark oxygen levels, collect and analyze blood, biopsy your dog’s tumor
under anesthesia, and do a CT scan to plan for radiation therapy and administer the oxygen carrier.
On Day 2, we will administer another oxygen marker and biopsy of your dog's tumor under anesthesia.
On Day 4, we will take blood, anesthetize your dog for an additional biopsy and begin your dog’s radiation treatment which
will be once a week for four weeks.
After the second radiation treatment, another biopsy is collected.
Blood collection after the third and fourth radiation therapy session (each one week apart as part of the normal course of
treatment).
In the event of death, necropsy is encouraged to be performed to try to determine the cause of death.

Benefits:
The study will cover costs associated with study drugs, drug administration, day hospitalizations for the study, the radiation
planning CT scan and the associated anesthesia, blood work for the study, and biopsies. Additionally, the study will also
cover up to $2,000 in medical costs if there is an unanticipated side effect from the study and up to $2,000 credit onto your
dog’s medical bill at the end of the study to be used for the cost of radiation therapy.

Results from this study may lead to an improvement of your dog’s response to treatments such as radiotherapy.

Owner Responsibilities:
We expect that participation in this clinical trial will take 5 weeks and anticipate each visit taking 6-8 hours. If you decide to
have your dog participate in the trial, you will be responsible for keeping each scheduled appointment, ensuring that your
dog has not eaten food for at least 12 hours prior to any anesthetic procedure, and covering costs associated with the
radiation therapy required to enter the study.

Study #2: CT and PET/CT for staging of canine oral malignant melanoma
Location: University of California Veterinary Hospital Davis, CA
Contact: Teri Guerrero at tguerrero@ucdavis.edu or 1-530-752-0125. The Oncology Clinical Trial Coordinators via email
(oncologyclinicaltrials@ucdavis.edu) or phone (530-752-0125 or 530-752-9759)
www.vetmed.ucdavis.edu/clinicaltrials/current_trials/by_species/dogs.cfm

For a study flyer, click here.

Purpose:
Melanoma is the most common malignant tumor of the mouth in dogs. This tumor has a relatively high rate of metastasis
(tumor spread) and detection of metastasis is important as it can impact prognosis. In human medicine, staging (looking for
metastasis) for similar head and neck tumors regularly includes the functional imaging positron emission tomography (PET)
combined with computed tomography (CT). Currently, there is no standardized approach in veterinary medicine to assess
for metastasis in oral malignant melanoma in dogs. Previous research has found the feeling of lymph nodes on
examination can be an inaccurate assessment for cancer spread as they can be normal in size and still contain tumor cells.
Therefore, the purpose of this study is to compare lymph node palpation to the appearance of the local lymph nodes on
CT scan and a combined PET/CT scan to histopathologic results to determine which method may be the most reliable for
identification of metastatic (tumor filled) lymph nodes.

Eligibility:
Dogs diagnosed with oral melanoma with gross measurable disease. Deemed healthy enough for anesthesia

Exclusion:
Dogs that have received previous therapy with chemotherapy or immunotherapy. Previous radiation to the head/neck.
Owners unable/unwilling to have the mandibular lymph nodes excised. Dogs not deemed safe to undergo anesthesia.
Dogs with a resting or persistent blood glucose level >15g/dL, or with diabetes. Dogs with heads greater than 22cm that will
not fit in the machine.

Initial evaluation for participation:
Histologic (small piece of tumor) or cytologic (needle aspirate) diagnosis of oral or lip fold malignant melanoma
Bloodwork/urinalysis within two weeks.
3-view chest x-rays within 1 month.
Initial required diagnostics can be performed elsewhere or with UC Davis, but are not covered by the study.

Procedures:
As part of this study, your dog will receive the same care and assessment as any dog with oral melanoma presented to the
UC Davis VMTH.

Day 0: PET/CT scans, which involve an injection of a radioactive tracer and hospitalization for one night
≤14 days after PET/CT scans: Mandibular lymph node (found under the chin) removal at UC Davis

Benefits:
This study will cover costs associated with CT and PET scans, surgical removal of your dog’s mandibular lymph node(s),
anesthesia, and up to $300 for study-related adverse events.

Your dog will receive the most advanced imaging techniques to assess their tumor as well as the local lymph nodes.
Results from this study will hopefully improve medical knowledge about the capabilities of CT and PET scans, potentially
limit unnecessary sampling and/or removal of lymph nodes, and better guide medical care for your dog and future dogs
affected with the same disease.

Owner Responsibilities:
If you allow your dog to participate in this study, you must agree to having your dog’s mandibular lymph nodes removed
following the CT/PET scans and would be responsible for costs associated with therapy to address your dog’s tumor such
as surgery, radiation and/or systemic treatment.

FLORIDA
Study: A Ganglioside Targeted Cancer Vaccine for Canine Melanoma
Location: University of Florida-Gainesville, Florida
Phone: Oncology Staff at the Small Animal Hospital 1-866-247-7950 or 352-392-2235 or Dr. Rowan Milner at milnerr@ufl.
edu
http://research.vetmed.ufl.edu/clinical-trials/small-animal/melanoma-vaccine-study-for-dogs/

Summary:
Melanoma (cancer of pigment producing cells in the body) is malignant cancer of both humans and animals. The main
treatment for the cancer in the dog is surgery. Unfortunately, a large number of these melanomas undergo metastasis
(spread) following surgery, shortening survival. This occurs even when surgery is done early and the tumor is removed in
its entirety. In an effort to improve survival, radiation and chemotherapy have been tried as adjunct (together with surgery)
treatment. Some marginal improvements in survival have been achieved but results are still poor. Because melanomas
have been known to induce an immune reaction in people and animals, developing a melanoma cancer vaccine holds
promise as an adjunct treatment to surgery. In a previously completed study in normal dogs, we showed that a vaccine
containing a melanoma antigen could induce an antibody response in dogs. We also showed that the vaccine could
stimulate peripheral blood natural killer cells to kill melanoma target cells in a laboratory test. The current research is to
test the vaccine in dogs with malignant melanoma.

Eligibility:
Any dog recently diagnosed with malignant melanoma that is resectable or minimal and does not have other life
threatening diseases. The doctors will explain this to you.

Exclusion:
Dogs with non-resectable melanoma or concurrent illness that would interfere with completion of the study protocol

Study Procedures:
Participation involves an initial staging visit and 5 follow up visits. The vaccine will be given 4 times approximately 4 weeks
apart followed by 2 restaging visits. Booster vaccines will also be available 6 months after completion of the entire vaccine
series at an additional charge.

Financial incentive:
Owners are expected to pay in advance for the cost of vaccines and initial examination. Subsequent visits will also be
responsibility of the client. Costs will be discussed prior to enrollment.You will need to schedule an Oncology Evaluation
Appointment for your dog. This evaluation appointment is not covered by the study but is a pre-requisite for determining
eligibility and does not guarantee that your dog will qualify to receive the vaccine.

PENNSYLVANIA
Study: Pilot Evaluation of Cancer Stem Cell Vaccine in Dogs with Melanoma
Location: Hope Veterinary Specialists--Malvern, Pennsylvania
Contact: 610-296-2099 or oncology@hopevs.com
http://hopevs.com/specialties/clinical-trials/melanoma/

Summary:
Cancer stem cells (CSC) are now considered a primary driver of tumor recurrence following chemotherapy or radiation
therapy, as well as a driver of cancer spread. There currently are no therapeutics that can selectively target CSC for
elimination. This study is designed to target CSC for immune elimination using properly designed stem cell vaccines.
Preliminary work in mouse models has shown favorable responses.

Importantly, immunization with CSC vaccines prepared from allogeneic (from other animals) tumor cell lines also induces an
anti-tumor immune response, indicating these vaccines can be successfully prepared from other patients tumors.
Moreover, CSC vaccines prepared from completely unrelated tumors histologically also generate anti-tumor immunity,
suggesting that CSC vaccines may in some sense be considered “universal” tumor vaccines.

Purpose:
This study is intended to provide an early proof-of-principal evaluation of the new stem cell vaccine technology in dogs with
melanoma and its ability to induce anti-tumor immunity.

Eligibility:
Dogs with histologically diagnosed oral melanoma (stage II-III) that have been clinically staged (bloodwork, urinalysis, chest
radiographs,).
Direct measurement of the tumor is needed (stage II means tumor ≥ 2 cm).
The tumor is accessible to fine needle aspiration.
No concurrently immunosuppressive medication or myelosuppressive chemotherapy during the 3-month trial.

Study Procedures:
Dogs enrolled in the study will receive a series of 8 immunizations over a 3-month period (4 weekly immunizations, followed
by 4 bimonthly immunizations). The vaccines will be administered under the skin over the flank (2 sites). Tumors are
measured and photographed on an every other week basis using digital calipers. For dogs that experience an objective
tumor response, the vaccine will be made available for 3 additional monthly administrations (total of 6 months of treatment).
Animals that develop a progressive disease (increase in tumor volume by more than 50%), develop tumor-related adverse
events or developed any serious medical illnesses will be removed from the study.

Cost:
Partial funding is available to help cover costs associated with study screening and examinations. Study patients will
receive the study vaccine at no cost and costs associated with the shipment of blood samples to the Tumor Immunology
Laboratory will be covered by the sponsor.