VARIOUS LOCATIONS
COTC021 Study: Evaluation of Orally Administered mTOR inhibitor Rapamycin in Dogs in the Adjuvant
Setting with Osteosarcoma

COTC022 Study: A Contemporaneous Controlled Study of the Standard of Care (SOC) in dogs with
Appendicular Osteosarcoma

Locations:  
University of Missouri--Columbia, Missouri
Auburn University--Auburn, Alabama
University of California-Davis--Davis, California
Colorado State University--Fort Collins, Colorado
University of Georgia--Athens, Georgia
University of Illinois--Urbana, Illinois
Kansas State University--Manhattan, Kansas
Tufts University--North Grafton, Massachusetts
North Carolina State University--Raleigh, North Carolina
Ohio State University--Columbus, Ohio
Oregon State University--Corvallis, Oregon
University of Pennsylvania--Philadelphia, Pennsylvania
University of Tennessee--Knoxville, Tennessee
Texas A and M University--College Station, Texas
Virginia-Maryland Regional College of Veterinary Medicine--Blacksburg, Virginia
University of Wisconsin--Madison, Wisconsin

Summary:
These studies seek to evaluate the safety and effectiveness of Standard of Care therapy, with or without adjuvant
rapamycin administration. Standard of Care is defined as amputation of the affected limb, followed by four doses of
carboplatin given every three weeks. Dogs will be randomized to either COTC021 or COTC022 at the start of therapy, which
will determine the treatment prescribed.

Purpose:
To determine if the  addition of rapamycin to a standard of care chemotherapy protocol will improve the long term outcome
for the patients (COTC 21).
To have a control population of dogs treated with standard of care chemotherapy at the same time (COTC 22).
Dogs will be assigned to one of the two protocols.

Eligibility:
Cytologic or histopathologic confirmation of osteosarcoma diagnosis, of a limb.
No evidence of metastatic disease.
Healthy otherwise.
No prior therapy.
> 25 kg in weight.

Procedures:
Determine eligibility with initial screening: physical exam, blood tests (CBC, biochemistry, urinalysis), confirmation of
osteosarcoma diagnosis, chest x-rays to confirm there are no metastases.
Surgery- amputation of affected limb.
Approximately 2 weeks after surgery- start chemotherapy given every 3 weeks for 4 doses.
Week 15 start rapamycin therapy if on that treatment protocol – will continue for 16 weeks.

Owner Responbilities:
To make and keep all study related appointments
To have limb amputation surgery performed at CSU
To administer rapamycin orally at home to your dog (if assigned to that protocol)
To keep a journal when administering rapamycin (if assigned to that treatment protocol)

Financial Incentives:
Owner to pay initial office call, staging and post chemo CBCs. Owner to receive $1000.00 credit towards amputation. Once
enrolled study is mostly funded. Study covers following costs: drug and drug administration, blood work at chemo visits,
imaging (radiographs) and VHC office calls.

VARIOUS LOCATIONS
Study: Field Safety Testing of Canine Osteosarcoma Vaccine, Live Listeria Vector
Contact: Laura Treml at ltreml@aratana.com or 1-913-353-1011

Locations:
Las Vegas Veterinary Specialty Center--Las Vegas, Nevada
Southern Arizona Veterinary Specialty and Emergency Center--Tucson, Arizona
Veterinary Specialty Hospital of San Diego--San Diego, California
Veterinary Cancer Center--Norwalk, Connecticut
University of Pennsylvania--Philadelphia, Pennsylvania

Purpose:
This study is designed to demonstrate the safety of Canine Osteosarcoma Vaccine, Live Listeria Vector, an
immunotherapeutic under evaluation as an aid in the treatment of dogs diagnosed with osteosarcoma.  This product is not
yet licensed. Dogs that have undergone amputation and received 4-6 doses of carboplatin may be screened and, if
enrolled, will receive three doses of the immunotherapeutic.

Elibility:
Histopathologic diagnosis of osteosarcoma.
Amputation of affected limb.
Received 4-6 cycles of carboplatin FOLLOWING amputation.
Other inclusion criteria should be discussed with investigator

Exclusion:
Evidence of pulmonary metastatic disease on thoracic radiographs.
Other exclusion criteria should be discussed with investigator

Financial Incentive:
The study will pay for all visits and clinical and diagnostic tests associated with the clinical trial, three doses of vaccine, and
treatment of any side effects associated with the vaccine.

VARIOUS LOCATIONS
Study:  Evaluation of Orally Administered mTOR Inhibitor Rapamycin in Dogs in the Adjuvant Setting
with Osteosarcoma

Locations:
University of Illinois--Urbana, Illinois
Auburn University--Auburn, Alabama
University of California-Davis--Davis, California
Colorado State University--Fort Collins, Colorado
University of Florida--Gainesville, Florida
University of Georgia--Athens, Georgia
Kansas State University--Manhattan, Kansas
Tufts University--North Grafton, Massachusetts
University of Missouri--Columbia, Missouri
North Carolina State University--Raleigh, North Carolina
Ohio State University--Columbus, Ohio
Oregon State University--Corvallis, Oregon
University of Pennsylvania--Philadelphia, Pennsylvania
University of Pennsylvania--Philadelphia, Pennsylvania
University of Tennessee--Knoxville, Tennessee
Texas A and M University--College Station, Texas
Virginia-Maryland Regional College of Veterinary Medicine--Blacksburg, Virginia
Washington State University--Pullman, Washington
University of Wisconsin--Madison, Wisconsin

Purpose:
Pulmonary metastasis continues to be the major cause of mortality among human and canine patients with osteosarcoma. A
series of investigational agents will be evaluated in dogs with appendicular osteosarcoma with the hopes of identifying new
drugs that help dogs live longer after being diagnosed with osteosarcoma. Rapamycin is a drug that may help slow down the
progression of cancer cells, by blocking a pathway that helps cancer cells grow and opening up a pathway that promotes
cell death. In doing so we hope that rapamycin would slow the spread of osteosarcoma to different parts of the body, most
commonly the lungs. It is hoped that slowing the progression of osteosarcoma will result in longer survival of dogs
diagnosed with osteosarcoma. Should you decide to enroll your pet into this clinical trial, your dog will receive standard of
care therapy, which includes amputation and four doses of carboplatin given once every three weeks. After your pet
completes the carboplatin therapy they will begin receiving rapamycin, which will be given once daily at home Monday–
Thursday for up to four months.

Eligibility:
Dogs with histologically or cytologically confirmed appendicular osteosarcoma.
Dogs must be at least 25 kilograms in weight.
Dogs cannot have been treated with chemotherapy, radiation therapy, or bisphosphonates.
Dogs cannot have any evidence of metastatic disease.
Dogs cannot have any significant co-morbid illness affecting the kidney, liver, or bone marrow.

Eligibility Diagnostics:
Prior to study entry, pet owners will be financially responsible and required to have the following diagnostics performed on
their pet: 1) Screening blood work and urinalysis; 2) thoracic radiographs and abdominal ultrasound; 3) cytologic or
histologic confirmation of appendicular osteosarcoma.

Treatment:
All dogs enrolled will receive standard of care, which includes limb amputation and systemic chemotherapy. Some dogs will
go on to receive oral rapamycin at home for four months.

Compensation:
The study will pay for $1,800 for amputation and $200 per chemotherapy treatment. All additional costs associated with the
investigation will be paid for by study funds, which include all costs directly associated with scheduled recheck visits (drug
administration, hospitalization, and blood work) during the entirety of the study period. Pet owners will be responsible for
initial diagnostics performed to confirm study

CALIFORNIA
Study: Radiation and Autologous Natural Killer Immunotherapy in Canine Osteosarcoma
Location:  University of California-Davis--Davis, California
Contact:   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, please click here.

Purpose of Study
:
Even when we can get local control of osteosarcoma, most dogs will die of their disease within a year even if they have
amputation and chemotherapy. The goal is to see if we can slow or stop the formation of lung metastasis (spread of tumor
to your dog’s lungs which occurs in over 90% of cases).

Participation Requirements:
Dogs diagnosed with or strongly suspected of having osteosarcoma in the pelvis or one of the legs based on x-rays and
staging tests to ensure his/her general health and to evaluate how advanced the disease is prior to treatment.

Initial Evaluation for Participation:  
You are responsible for covering initial office visit, chest films, blood work (CBC/Biochemistry Panel), urinalysis, and
diagnosis confirming Osteosarcoma.

Procedures:
After enrollment, UC Davis will do a CT scan of the tumor and lungs, take a biopsy, collect blood (to grow your dogs natural
killer cells), and complete a standard dose of palliative (pain reducing) radiation consisting of four once weekly doses.
One week after finishing radiotherapy, UC Davis will give the first of two injections into your dog’s tumor with your dog’s NK
cells that we have grown, and take a biopsy.
One week later, you need to come back for the second injection of NK cells.
Three and six months later, UC Davis will then need you to come back for a CT of the lungs and a biopsy.

Benefits:
While palliative radiation is known to be beneficial in decreasing pain in the majority of dogs with osteosarcoma, we do not
know if there will be a direct therapeutic benefit to your dog or other dogs by your enrolling your dog to take part in this trial
but we hope to help come up with a new treatment for this disease.

Owner Responsibilities:
Once enrolled in the clinical trial, you are responsible for scheduling and keeping all appointments needed for study
participation and reporting any side effects of the treatment to your doctor in a timely manner.

Cost:
You are responsible for covering costs associated with the initial diagnosis and palliative radiotherapy. After determining if
your dog is eligible and you agree to participate, the study will cover the cost of biopsies, CT scans, anesthesia for the
injection of the activated immune cells as well as the cost for us to grow these cells. You will also receive a credit of $1,500
towards the cost of palliative radiation to be applied to your bill at the VMTH at the day of second injection of the NK cells. In
the event any complications arise during the study period that are related to biopsy or intratumoral injections but not your
dog’s tumor, their management will be covered by study funds up to $1000/per dog to be used at the UC Davis VMTH.

COLORADO / ILLINOIS
Study: Open-Label, Phase-2 Trial of NV-01 for Pain Palliation in Dogs with Osteosarcoma
Location:  Colorado State University Animal Cancer Center; University of Illinois--Urbana, Illinois
Phone:     Oncology Clinical Coordinator at (970) 297-4068 in Colorado; 217.333.5300 in Illinois
www.csuanimalcancercenter.org/nv-01_pain_palliation_osteosarcoma

Eligibility:
Certain criteria will determine if your pet qualifies for this study. Dogs with OSA of a leg may be eligible for this study. They
may not have received previous treatment, including radiation therapy, chemotherapy, or bisphosphonates, for their OSA.
Dogs previously treated with nonsteroidal anti-inflammatory drugs (NSAIDs) are eligible. Dogs with spread of the OSA to
other locations in the body (metastasis) may be eligible. Patients must be in good health and have relatively normal blood
work prior to starting this study. Dogs with fractures at the tumor site are not eligible to enroll in the study. Dogs may not
receive homeopathic/alternative therapies while on study; these must be discontinued prior to enrollment. Owners must
consent to a postmortem examination (autopsy) at the time their pet dies or is euthanized.

Summary:
Osteosarcoma (OSA) is the most common form of bone cancer in dogs and humans. It occurs most often in larger-breed
dogs. Osteosarcoma is characterized by aggressive, painful bone destruction and a high rate of spread to other locations in
the body (known as “metastasis”). Despite improvements in surgical treatment and chemotherapy, 80% of dogs still will die
from this disease. Many older, large-breed dogs may not be candidates for “definitive” treatments, such as amputation, due
to co-existing nervous-system or bone diseases, presence of metastasis, owner reluctance, or financial constraints.

New forms of treatment to control OSA pain are desperately needed. It has been shown that nerves to normal bone and
bone tumors are influenced by nerve growth factor (NGF). In mice, bone cancer pain can be alleviated by administration of
drugs that inhibit NGF without altering normal nerve function. It has also been shown that OSA in dogs expresses the
receptor for NGF. NV-01 is an antibody against NGF that blocks the activity of NGF by preventing from binding to its
receptor in bone tumors and nerves. This clinical trial will evaluate the benefit of the NV-01 monoclonal antibody therapy for
the treatment of pain in canine patients with OSA.

Procedures:
Initially your pet will undergo a series of diagnostic tests, which may include a physical examination, blood work, urinalysis,
chest X-rays and X-rays of the affected leg. The results of these initial staging tests will determine if your pet is eligible to
enter this clinical trial. These tests are part of the routine testing done in OSA patients, and often are performed even if you
decide that your pet will not participate. All dogs in this study will be standardized to receive a non-steroidal anti-
inflammatory drug and tramadol as pain medications.

Once enrolled, blood and urine will be collected for study purposes and the dogs will have a force plate gait-analysis
performed to objectively determine how much weight the dog is placing on the affected limb. The monoclonal antibody NV-
01 will be administered intravenously once over 5 minutes on the first day of the study (Day 0) and blood samples will be
collect at 1, 2 and 4 hours after treatment. Dogs will be evaluated the following day and blood and urine collected for the
study. On Days 3 (or 4), 7, 14, 21 and 28, dogs will be rechecked to assess their comfort level and collect blood and urine
samples. Additionally, gait analysis will be performed again on Days 7, 14 and 28. For dogs that experience stabilization or
improvement in their comfort level, a second treatment can be performed on Day 28, and then every 4 weeks after that time.
Chest and limb X-rays will be obtained at the 8-week follow-up evaluation.

Benefits:
Clients participating in this study will be given special financial considerations. Specifically, the study will pay for all costs
related to treatment and follow-up evaluations. Should NV-01 be ineffective for your dog’s treatment, a $750.00 credit will be
applied to your dog’s account at the CSU VTH, which can be used for subsequent treatment.

Owner Responsibilities:
You are responsible for the cost of diagnosing and staging your dog’s OSA (~$500) prior to entering the study. You are
expected to make and keep all appointments according to the study protocol. You must be committed to completing the
study protocol.

COLORADO
Study #1: Evaluation of Cancer Stem Cell Vaccine in Dogs with Metastatic Osteosarcoma
Location:  Colorado State University Animal Cancer Center
Phone:     Oncology Clinical Coordinator at (970) 297-4068
www.csuanimalcancercenter.org/evaluation-of-cancer-stem-cell-vaccine-in-dogs-with-metastatic-osteosarcoma

Purpose of the study:
Cancer stem cells are a primary driver of tumor recurrence and metastasis (spread to other locations)
It may be possible to target these cancer stem cells for elimination by the immune system, and the goal of this study is to
assess tumor responses to this type of vaccination.

Primary Eligibility Criteria:
Diagnosis of osteosarcoma, with evidence of metastases (tumor spread) to the lung tissue.
Patient is healthy otherwise.

Study Protocol:
Pre-enrollment: Physical exam, labwork, chext x-rays
Every two weeks to week 9: Physical exam, lab work, vaccination
Every four weeks thereafter: Physical exam, lab work, vaccination, chest x-rays

Owner Responsibilities:
Initial diagnostics, exam fees, and other tests recommended by the oncologist are the owner’s responsibility.
To make and keep all appointments associated with the trial.

Financial Incentives:
The vaccinations are provided at no cost associated with the trial.
The trial will cover the costs of recheck chest x-rays for the duration of the trial.

Study #2: Predictive Models of Drug Response in Canine Osteosarcoma: A Prospective Clinical Trial
Testing the COXEN Approach
Location:  Colorado State University Animal Cancer Center
Phone:     Oncology Clinical Coordinator at (970) 297-4068
www.csuanimalcancercenter.org/predictive-models-of-drug-response-in-canine-osteosarcoma

Purpose of the study:
Use a model (COXEN) to predict which of the standard chemotherapy protocols an individual dog’s tumor is most sensitive
to. Administer (post amputation) chemotherapy to the patient based on the predictions generated by the model. Determine if
this gives better outcomes for those patients (longer survival).

Eligibility:
Dogs with confirmed or suspected diagnosis of osteosarcoma of a limb, with no evidence of metastases (chest x-rays)
Dogs must be free of other serious diseases (physical exam, blood tests)
All dogs must have amputation as the treatment of the tumor, performed at CSU
They cannot have had any prior treatment for the tumor

Study Protocol:
Initial screening tests (physical exam, blood and urine test, x-rays of the affected limb and chest)
Surgery to amputate limb (tumor samples will be analyzed by COXEN method)
Further visits will be for blood tests, chemotherapy treatments (determined based on COXEN results of tumor analysis),  and
intermittent chest x-rays

Owner Responsibilities:
To make and keep all study related appointments
Owner is responsible for finances, aside from the points listed below

Financial Incentives:
The study pays for the cost of the COXEN analysis to determine drug sensitivity of tumor
The study pays for chest x-rays until the development of metastatic disease
The owner would be responsible for all other costs associated with the dogs treatment and participation in this study

FLORIDA
Study: A Ganglioside Targeted Cancer Vaccine for Canine Osteosarcoma: A Phase 1 Trial          
Location: University of Florida--Gainesville, Florida
Contact:  Oncology Staff at the Small Animal Hospital 352-392-2235 or by email at Oncologydept@vetmed.ufl.edu
http://research.vetmed.ufl.edu/clinical-trials/small-animal/vaccine-study-for-dogs-with-osteosarcoma/

Background:
Osteosarcoma is malignant cancer of both young humans and animals. The standard of care for humans and dogs with
osteosarcoma is surgery followed by chemotherapy. Unfortunately, a large number of these osteosarcomas undergo early
metastasis (spread) following surgery. This occurs even when surgery is done early and the tumor is removed in its entirety
and chemotherapy is given. Infections of the osteosarcoma surgery site have been known to cause an immune reaction in
people and animals improving overall survival. Since overall survival is dismal in patients with osteosarcoma, developing an
osteosarcoma cancer vaccine holds promise as an adjunct treatment to surgery and chemotherapy. In a previous study of
400 dogs with melanoma we showed that a vaccine containing the ganglioside (GD3) causes a measurable immune
response in normal dogs and dogs with melanoma and prolonged survival.

Eligibility:
Any dog recently diagnosed osteosarcoma and does not have other life threatening diseases and has not received any
chemotherapy.  More specific inclusion criteria will be discussed with you during your pet’s evaluation.  Your dog will have
the vaccine in addition to whichever standard of care therapy you choose (amputation+chemotherap or radiation +
chemotherapy).

Treatment:
The vaccine will be given over 4 visits approximately 3 weeks apart in addition to 6 chemotherapy visits.  The chemotherapy
visits will be scheduled 2 weeks prior to each vaccine visit. At each visit, blood will also be drawn to measure the immune
response.

Cost:
The study will cover only the cost of the vaccine at each of the four visits (i.e. approximately $560 per dog for 4 vaccines) to
a maximum of 20 dogs. Complications due to the vaccine are not expected, but should any arise, the study will pay for those
treatments directly associated with the injection site reaction to a maximum of $100.00. No other costs will be covered.  The
costs for amputation, chemotherapy and radiation are not covered as part of this study and will be discussed with you
during your evaluation appointment. 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.

MINNESOTA
Location:  University of Minnesota--St Paul, Minnesota
Contact:  Andrea Eckert at aleckert@umn.edu or 1-612-625-3157
www.vetmed.umn.edu/centers-programs/clinical-investigation-center/current-clinical-trials/vigor-trial-translational-approach-
development-novel-oncolytic-immunotherapy-osteosarcoma

Background:
Osteosarcoma (OSA), the most common bone tumor found in the dog, has already spread by the time we diagnose 90% of
the cases. Survival times are limited, from 3-4 months with surgery alone, and 9-14 months with the addition of
chemotherapy. In order to improve survival in dogs, newer therapies are needed. We are studying genetically modified
Vesicular Stomatitis Virus (VSV-IFNß-NIS) which has been shown to be effective against cancer in the laboratory and in a
pilot study of eight dogs.

Eligibility:
Dogs with osteosarcoma in a limb bone who:
weigh more than 44 lbs (20 kg)
feel well with no significant health concerns
are spayed or neutered
are up-to-date on vaccines, flea/tick prevention and internal pest control
have no evidence of metastasis on chest x-ray
have no previous chemotherapy or radiation therapy
not be taking alternative or herbal medications
not be near livestock (VSV is a concern in livestock)
are willing to discontiue prednisone or other immunosuppressive drugs for two weeks prior to enrolling in the study
Visits:

Procedures:
Day -2 screening: exam, blood and urine collection, CT scan of the chest and abdomen to check for metastasis

Week 1: dogs typically spend the week at the Veterinary Medical Center (VMC). We will perform a tumor biopsy under
anesthesia and take baseline samples of blood, cheek, urine and stool on Monday.

On Tuesday dogs receive the treatment with VSV-IFNß-NIS and will be housed in isolation, closely monitored by our team,
for a period of time (6-24 hrs). We will sample blood, cheek, urine and stool periodically to detect virus shedding and
immune responses.

On Wed - Fri, we will monitor the dog and take additional samples. Dogs go home on Friday.
Recheck visits weekly for first month

Day 10 amputation occurs - this is standard of care for dogs with osteosarcoma in a limb. The surgery is delayed to day 10
to give the VSV-IFNß-NIS some time to do its work.

Chemotherapy begins about Day 21, uses the drug carboplatin, scheduled through the VMC Oncology service
Recheck visits at month 3, month 6 and one year. Repeat the CT scan, typically at the 3 month visit.

Cost:
Owners are responsible for the screening appointment and staging diagnostics prior to Day -2 to determine if their dog is a
good candidate for the study. The study covers up to $8600 in care, which includes the procedures listed above and much
of the dog's chemotherapy.

WISCONSIN
Study: Stereotactic Radiation Therapy for Pain Relief and Immune Modification in Dogs with Limb
Osteosarcoma
Location: University of Wisconsin--Madison, Wisconsin
Contact: UW Veterinary Care Radiation Oncology Service at 608-263-7600 or radonc@vetmed.wisc.edu
https://uwveterinarycare.wisc.edu/clinical-studies/oncology/

For a study flyer, please click here.

Summary:
Radiation therapy’s primary use for canine osteosarcoma has been with a palliative intent to alleviate pain. Stereotactic
radiation therapy (SRT) is a highly accurate radiation delivery technique that potentially allows us to give a higher radiation
dose per treatment in fewer treatment sessions. This study will deliver 3 radiation treatments over 3 days and assess pain
relief with orthopedic exam, force platform analysis and client questionnaires. The primary aim of this study is to determine
the effectiveness of stereotactic radiation therapy to alleviate pain. We hypothesize that most dogs will experience
significant pain relief. Large doses of radiation per treatment have also been proposed to stimulate an immune response
against the cancer. To evaluate this, we aim to measure changes in proteins released from the tumor or its environment by
collecting blood samples before, during and after the radiation therapy.

Eligibility:
Dogs with a biopsy confirmed diagnosis of osteosarcoma of the limb may be eligible for this study. Dogs with a tumor-related
fracture, spread of cancer to lymph nodes or lungs or previous radiation or chemotherapy are not eligible. A CT scan will be
required for radiation planning and to determine study eligibility. Dogs will be evaluated at 1, 2, 4, 5, 7, 8, 10, 11, 12, and 14
weeks after radiation therapy.

Treatment:
Two weeks following completion of the third radiation treatment, dogs will start intravenous carboplatin chemotherapy.
Carboplatin will be administered once every 3 weeks for a total of 4 treatments.

Financial Incentive:
Clients will receive financial compensation, which will cover the cost of radiation therapy and follow-up force plate
evaluations. Clients are responsible for the cost of diagnosis and tests to determine if their dog is eligible for this study,
recheck examination fees, and for the carboplatin chemotherapy.
PET CANCER CENTER
Comprehensive guide to cancer diagnosis and treatment in cats and dogs
© 2007 Pet Cancer Center. ALL RIGHTS RESERVED.
Last updated 2/19/2017
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