Melanoma clinical trials for dogs.

Study: Exploratory safety study of an intravenous infusion of a novel therapeutic agent for the
treatment of melanoma, osteosarcoma, soft tissue sarcoma or squamous cell carcinoma in dogs

Available at the following locations:
ARIZONA: So uthwest Veterinary Oncology, Gilbert and Tucson, AZ (480-635-1110; 520-888-3177)
CALIFORNIA: Veterinary Specialty Hospital, San Diego, CA (858-875-7500); Veterinary Cancer Group, Culver City, CA
(310) 558-6120
CONNECTICUT: Veterinary Oncology & Hematology Center, Norwalk CT (203-838-6626)
MINNESOTA: University of Minnesota Veterinary Medical Center, Minneapolis, MN (612-626-5786 or 612-626-8387)
NEW ENGLAND: NEVOG, Waltham, MA (781-684-8688)
NEW JERSEY: Redbank Veterinary Hospital, Tinton Falls, New Jersey (732-747-3636)
OHIO: Ohio State University V eterinary Medical Center, Columbus, OH (clinicaltrials@cvm.osu.edu)
VIRGINIA: The Oncology Service, Leesburg, VA 20176 (571-439-6655)
WISCONSIN: University of Wisconsin Veterinary Teaching Hospital, Madison, WI (608-263-7600)

Summary: Dogs must have spontaneous measurable melanoma, osteosarcoma, soft tissue sarcoma, or squamous cell
carcinoma. “Measurable” may be a primary tumor or a metastatic lesion. Dogs that meet the eligibility criteria will be treated
with a single intravenous infusion of the therapeutic agent. Treated dogs will require close monitoring for 6 hours after
treatment with follow-up visits required 2, 4, 7 and 14 days post-treatment. While the patient remains on study, there will
also be rechecks at 1 and 2 months. In some study dogs, medications in addition to the therapeutic agent will be used.

Eligibility: To qualify for enrollment in this study, dogs must have:

Histologic or cytologic diagnosis of cancer (biopsy or needle aspirate)
There is at least 1 tumor (melanoma, osteosarcoma, soft tissue sarcoma, or squamous cell carcinoma) which can be
measured (minimum 1 cm in diameter)
Generally feeling well (i.e. eating, drinking, ambulating on their own, etc.)
No evidence of an active bacterial infection requiring antibiotics (other than topical medications) in the past 7 days
No anti-cancer therapy within the past 21 days. This includes chemotherapy, radiation therapy, prednisone (or other
forms of corticosteroids), and immunotherapy
No tumors where abscess (infection) would result in major symptoms

Background: Currently enrolling dogs for a nationwide clinical trial to evaluate a novel cancer treatment for measurable
melanoma, osteosarcoma, soft tissue sarcoma, or squamous cell carcinoma. The goal of this therapy is to specifically
target the tumor and induce an inflammatory response. The proposed benefit of such a response is to shrink existing
tumors and reduce or eliminate microscopic cancer cells that may not be visible by standard (or any) means. The purpose
of this study is to assess the safety and potential effectiveness of this therapeutic agent in dogs.

The therapeutic agent is a modified anaerobic bacterium. In previous trials, it has been shown to target the necrotic center
of malignant tumors, leading to tumor regression or stable disease in many of the small mammals tested. Common side
effects include fever, nausea and inflammation. The primary objective of this multi-institutional exploratory study is to
describe the safety and efficacy of three dosages of an intravenous infusion of C. novyi-NT spores, with and without
concomitant therapy, in dogs with spontaneous tumors.

Financial Incentive: The study sponsor will pay for therapeutic agent, diagnostic tests, and follow-up evaluations. In the
event that side effects are noted and attributed to the therapeutic agent, the study will pay for medical management of the
side effects.

CALIFORNIA
Study: Pegylated arginine deiminase for dogs with lymphoma or oral malignant melanoma
Location: University of California Veterinary Hospital Davis, CA
Phone: (530) 752-1393, ext 431
http://www.vetmed.ucdavis.edu/vmth/small_animal/oncology/studies.cfm#cancer

Eligibility: The dog must be examined by the VMTH Oncology or Radiation Oncology service veterinarian, and require the
following baseline evaluations at the owner's expense before a dog can be considered for enrollment in the trial:

• Confirmed diagnosis (histologically or cytologically)
• Physical examination with weight recorded
• CBC, Chemistry Panel and Urinalysis All within two weeks of enrollment (referring blood work is acceptable as long as it
was run at a commercial lab).

The dogs must also satisfy the following criteria:
• Measurable disease and tumor that can be biopsied
• Ability to stay overnight
• Dog has to be greater than 10kg
• Informed owner consent

Summary: The goal of this study is to evaluate the efficacy of using the enzyme Pegylated Arginine Deiminase (non-
chemotherapy drug) as a subcutaneous injection.

Financial incentives: This study is fully funded.

FLORIDA
Study: Vaccine Study for Dogs with Melanoma
Location: University of Florida
Phone: 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/

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

Summary: Melanoma (cancer of pigment producing cells in the body) is malignant cancer in both humans and animals.
Some forms of melanoma in the dog follow a similar aggressive pathway as it does in humans. The main treatment for
melanoma in dogs is surgery, however this cancer often spreads in the body and shortens the survival time. Radiation
treatment and chemotherapy have been used in combination with surgery but results are still poor. Because this type of
cancer has been known to cause an immune reaction in people and in animals, developing a vaccine holds promise to use
in addition to surgery. Vaccines are often used because they stimulate a response inside the body to fight infection or
prevent infection. It is our hope that this vaccine will stimulate a response in the body to kill the cancer that is present. In
prior laboratory experiments and clinical trials in healthy dogs, we have seen that this vaccine causes the body to produce
a response that kills melanoma cells.

The University of Florida College of Veterinary Medicine is currently recruiting dogs recently diagnosed with malignant
melanoma for a clinical research trial. This investigational trial is for the development of a vaccine for the future treatment
or prevention of melanoma in dogs.

Participation involves 7 visits to the clinic in one year and follow up visits every 3 months following treatment. Blood will be
drawn on your dog’s first visit to compare with blood drawn later in the study. The vaccine will be given 3 times in 3
separate body locations approximately 4 weeks apart.

Financial incentive: The study will pay for the vaccine and costs associated with monitoring your dog’s immune response.
You are responsible to pay for office visits.

MASSACHUSETTS
Study: Evaluation of DTIC chemotherapy for dogs with melanoma
Location: Tufts University Cummings School of Veterinary Medicine, North Grafton, MA
Phone: Kelly Reed, Oncology Liaison; (508) 887-4682
http://cgi.vet.tufts.edu/clinical_trials/projects/dtic_for_the_treatment_of_canine_melanoma

Eligibility: Dogs must have measurable tumor either at the primary site or metastasis and must be in good clinical condition.
Dog whose life expectancy is less than 3 months or whole have significant liver disease are ineligible.

Summary: DTIC is considered the gold standard of chemotherapy treatment for melanoma in people. The goal of this study
is to determine the efficacy of DTIC in treating dogs with this highly malignant cancer.

Requirement and incentive: The owner is financially responsible for all tests that determine if the patient qualifies for the
study. These tests may include initial specialty examination, chest x-rays, blood and urine tests. The study covers the cost
of two cycles of DTIC chemotherapy including re-check examination fee and cost of pre-treatment CBC/plt count.

WISCONSIN
Location: University of Wisconsin Veterinary Teaching Hospital, Madison, WI
Phone: (608) 263-7600
www.uwveterinarycare.wisc.edu/rdvm/clinical_trials.html

Summary: Malignant melanoma is a highly aggressive cancer that is resistant to standard chemotherapy. Surgery and/or
radiation therapy may control the primary tumor, but most dogs die within one year. Tyrosine kinases are proteins that play
a key role in regulation of cell growth. Evidence suggests that in humans and companion animals, tyrosine kinases are
often abnormally activated leading to uncontrolled cell growth. Masitinib is a tyrosine kinase inhibitor that has been found
to prolong the time to disease progression in dogs with mast cell tumors. The purpose of the proposed study is to evaluate
the antitumor activity of masitinib when given alone or in combination with currently available treatments for dogs with
melanoma. In the proposed studies, dogs with melanoma will be randomized to receive masitinib alone, Oncept (Canine
Melanoma Vaccine) alone, or masitinib combined with the chemotherapy drug doxorubicin. The cost of masitinib, Oncept,
and doxorubicin will be paid for by the study. Owners are responsible for the cost of the initial staging (approximately $400-
600), blood and urine tests, and examination fees.