MULTIPLE LOCATIONS
COTC021:Evaluation of Orally Administered mTOR inhibitor Rapamycin in Dogs in the Adjuvant Setting
with Osteosarcoma
COTC022: A Contemporaneous Controlled Study of the Standard of Care (SOC) in dogs with
Appendicular Osteosarcoma
Recruitment Open until 12/15/2018

Locations:  
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.

Eligibility:
Appendicular osteosarcoma confirmed by histopathology or cytology, normal CBC, chemistry panel, UA, abdominal
ultrasound, and thoracic radiographs within 10 days of amputation at MU-VHC. Patient must weigh over 25 kgs ,  with a
favorable performance status and no prior chemotherapy, radiation therapy or bisphosphonates, NSAIDS, gabapentin,
tramadol are allowed prior to and during study.

Procedures:
Surgical amputation of affected limb at MU-VHC. First carboplatin infusion within 2 weeks of surgery, then every 3 weeks for
total of 4 doses. Oral rapamycin to start within 7 days of week 15 visit- Monday - Thursday administration. Return visits on
Days 11, and 25, then monthly of every rapamycin cycle for overnight pharmacokinetics.

Financial Incentives:
Owner to pay initial office call, staging and post chemo CBCs. Owner to receive $1000.00 credit towards amputation at the
MU-VHC. 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..

MULTIPLE LOCATIONS
Study: Field Safety Testing of Canine Osteosarcoma Vaccine, Live Listeria Vector
Recruitment Open until 02/15/2019

Locations:
Southern Arizona Veterinary Specialty and Emergency Center (Tucson, Arizona)
Veterinary Cancer Group of Los Angeles (Culver City, California)
SAGE Centers for Veterinary Specialty and Emergency Care (Campbell, California)
Veterinary Specialty Hospital by ETHOS (San Diego, California)
VRCC Veterinary Specialty & Emergency Hospital (Englewood, Colorado)
Veterinary Cancer Center (Norwalk, Connecticut)
Southeast Veterinary Oncology and Internal Medicine (Jacksonville, Florida)
Blue Pearl Specialty + Emergency Pet Hospital (Tampa, Florida)
MedVet Medical & Cancer Centers for Pets (Carmel, Indiana)
Iowa State University (Ames, Iowa)
Blue Pearl Specialty + Emergency Pet Hospital (Overland Park, Kansas)
New England Veterinary Oncology Group (Waltham, Massachusetts)
Blue Pearl Specialty + Emergency Pet Hospital (Southfield, Michigan)
Oradell Animal Hospital (Paramus, New Jersey)
VCA Veterinary Care Animal Hospital and Referral Center (Albuquerque, New Mexico)
Katonah Bedford Veterinary Center (Bedford Hills, New York)
MedVet Medical & Cancer Centers for Pets (Worthington, Ohio)
Veterinary Cancer & Surgery Specialists (Milwaukie, Oregon)
Hope Veterinary Specialists (Malvern, Pennsylvania)
Upstate Veterinary Specialists (Greenville, South Carolina)
Sugar Land Veterinary Specialists and Emergency Care (Sugar Land, Texas)
Veterinary Specialist of North Texas (Ft. Worth, Texas)
The LifeCentre (Springfield, Virginia)
Bridge Animal Referral Center (Edmonds, Washington)
Wisconsin Veterinary Referral Center (Waukesha, Wisconsin)

Purpose:
This study is designed to collect additional safety data for Canine Osteosarcoma Vaccine, Live Listeria Vector (AT-014),
which is conditionally licensed by the United States Department of Agriculture (USDA). Dogs must have undergone
amputation of the affected limb and have completed chemotherapy prior to entering the study.

Not all sites are currently enrolling patients. Please contact sites directly to determine eligibility and timing of possible
enrollment.

Elibility:
1. Signed Owner Informed Consent
2. Client owned dog > 1 year of age
3. Body weight ≥ 2 kg
4. Histopathologic or cytologic diagnosis of osteosarcoma
5. Amputation of the affected limb followed by a completed chemotherapy regimen
6. ECOG Performance score of 0 or 1 [0=normal activity; 1=restricted activity, decreased activity from pre‐disease status,
2= compromised, ambulatory only for vital activities,consistently defecates and urinates in acceptable areas]

Exclusion:
1. Clinically relevant abnormalities on CBC/CS/UA
2. Evidence of pulmonary metastases on 3‐view thoracic radiographs
3. Prior immunotherapeutic treatment for osteosarcoma
4. Any uncontrolled medical condition (including other concurrent malignancy) that may be disruptive to the intent and
objectives of the study
5. Dog is pregnant, lactating or likely to become pregnant
6. Dog is participating in another study
7. Dog may not be available for the entire study duration

MULTIPLE LOCATIONS
Study: Evaluation of a recombinant, attenuated Listeria monocytogenes expressing a chimeric human
HER2/neu protein in dogs in the adjuvant setting for osteosarcoma
Recruitment Open until 12/31/2019

Locations:  
Colorado State University (Fort Collins, Colorado)
Kansas State University (Manhattan, Kansas)
Tufts University (North Grafton, Massachusetts)
Ohio State University (Columbus, Ohio)
University of Pennsylvania (Philadelphia, Pennsylvania)

Purpose of Study:
This clinical trial seeks dogs with osteosarcoma to evaluate the safety and effectiveness of a new vaccine following standard
of care therapy. Bone cancer or osteosarcoma (OSA) is a common, highly aggressive cancer that frequently affects the
long bones of large breed dogs. Current standard of care therapy consists of surgical limb amputation plus 4 doses of
chemotherapy, given in a vein, every 3 weeks.  

The immune system plays an important role in identifying and targeting cancer cells in the body. In this study, we aim to use
a new approach to stimulate the body’s own immune system to attack remaining tumor cells in dogs that have undergone
limb amputation and chemotherapy for the treatment of OSA. We will use a study vaccine, which has been modified to
express a tumor protein (HER-2/neu) that is found in many cancer cells, including canine bone cancer cells and cancer stem
cells. The hope is that when injected into the bloodstream, the vaccine stimulates the immune system to attack cells
expressing the HER-2/neu tumor protein. This approach aims to delay and/or prevent the spread of cancer (metastases)
following removal of the primary bone cancer tumor (limb amputation) and chemotherapy. Interactions with other drugs are
unknown, so it is necessary to disclose any medications (and supplements) your dog is currently taking to the oncologist. It
is strongly encouraged to eliminate all unnecessary medications. .

Inclusion Criteria:
Dogs greater than 50 pounds post-amputation surgery with histological or cytological confirmation of appendicular
osteosarcoma, which includes all long bones of the limbs (radius, ulna, humerus, scapula, femur and tibia) PRIOR to
amputation. Dogs must have measurable disease that is amendable to surgical removal via amputation and no evidence of
metastasis on physical exam, thoracic radiographs, and abdominal ultrasound. Dogs must be newly diagnosed without prior
therapy (conventional or metronomic chemotherapy, ionizing radiation, or bisphosphonates.) Dogs must not have significant
co-morbid illness (including but not limited to renal or hepatic failure, history of congestive heart failure, or clinical
coagulopathy) and certain blood work parameters must be met.

Exclusion Criteria:
Dogs less than 50 pounds with osteosarcoma on non-long bones including ribs, metatarsus, metacarpus, carpal and tarsal
bones, and digits. Dogs with evidence of metastasis or who have already undergone amputation or who have prior therapy
for osteosarcoma are excluded. Dogs with significant co-morbid illness (including but not limited to renal or hepatic failure,
history of congestive heart failure, or clinical coagulopathy) or who do not meet blood work parameters will be excluded.

Potential Medical Benefits:
Potential delay of metastatic disease.

Potential Medical Risks:
Fever, lethargy, gastrointestinal upset (vomiting, diarrhea, inappetence), cardiac arrhythmias, hyper/hypotension, low
platelet counts (blood clotting cells), high or low white blood cell counts, anemia (low red blood cells), worsening kidney
function, elevated liver enzymes, rash, sepsis, even death. This is an experimental drug that may affect your dog in ways
unknown.

Owner Responsibilities:
If you allow your dog to participate in this study, you will be responsible for having the limb amputated at UC Davis, bringing
your dog to all required study appointments, recording their rectal temperature 12 hours after your pet receives each
vaccine, reporting any side effects, and covering costs of the initial examination with the UC Davis Oncology Service, the
screening diagnostic tests, which includes blood and urine collection and analysis, chest x-rays and abdominal ultrasound
and amputation, the four doses of carboplatin (as well as the associated tests, which includes bloodwork and chest x-rays),
any costs associated with management of side effects from the Standard Therapy Phase of this study (amputation and
carboplatin chemotherapy)..

Cost:
Partially funded (owner cost >$1000).

ALABAMA
Study: Evaluation of zoledronate for the treatment of canine metastatic osteosarcoma
Location:  Auburn University -- Auburn, Alabama
Contact:   Auburn Oncology Service (334) 844-4690
Recruitment Open until 12/31/2018

Summary:
Currently, there are no proven effective therapies for canine metastatic osteosarcoma. This study investigates the use of
zoledronate, a bisphosphonate drug, for the treatment of pulmonary nodules associated with osteosarcoma metastasis.
Bisphosphonates have documented efficacy for control of cancer-associated bone pain. In addition to its palliative
properties, zoledronate has more recently been investigated for its ability to induce cancer cell death as well interfere with
the development of metastasis. The therapeutic dose has been previously characterized and side effects are limited to
rare reports of renal injury and osteonecrosis of the jaw. We intend to administer zoledronate once monthly to dogs with
pulmonary metastatic osteosarcoma in order to assess its efficacy in this species.

Participation Requirements:
Once monthly visits to the Auburn Oncology service, which include:
  • Three view thoracic radiographs
  • BUN, creatinine, urine specific gravity
  • Zoledronate administration IV over 15 minutes
  • This study is fully funded for up to 6 months of treatment
  • Patients will be removed from the trial at the time of cancer progression.

Inclusion criteria:
  • Histopathologic diagnosis of appendicular osteosarcoma
  • Thoracic radiographs with at least one metastatic lung lesion > 2.0 cm
  • Primary bone tumor treated with limb amputation, surgical limb-spare, or palliative radiation therapy
  • Prior treatment with chemotherapy is allowed, but patients must have cancer progression at the time of enrollment.

Exclusion criteria:
  • Osteosarcoma arising from a non-appendicular site (e.g., skull, ribs, soft tissue)
  • Pathologic fracture
  • Renal azotemia with serum creatinine > 2.0 mg/dL
  • Other comorbidities may be excluded on a case-to-case basis
  • Concurrent treatment with chemotherapy, immunotherapy, or purported anti-tumor supplements (NSAIDs and
    analgesics allowed)

Cost:
The client is financially responsible for the initial consultation and screening tests to determine eligibility (thoracic
radiographs, chemistry panel, urinalysis). The remainder of this trial is funded for up to 6 months of treatment. Available
$500 towards treatment of any drug-related complications at Auburn. If the client fails to return for the first recheck
examination (> 35 days post-treatment), then they will be billed for the expenses associated with the previous treatment.

CALIFORNIA
Study: Evaluation of a recombinant, attenuated Listeria monocytogenes expressing a chimeric human
HER2/neu protein in dogs in the adjuvant setting for 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)

Purpose of Study:
Standard therapy for dogs diagnosed with osteosarcoma has long been amputation of the affected limb followed by
chemotherapy to delay the spread of cancer. With this form of treatment, survival times of dogs diagnosed with
osteosarcoma is on average about 10 to 12 months with little improvement in survival occurring over the past two decades.
ADXS31-164c is a vaccine that is designed to cause the immune system to inhibit an important receptor that may aid in
cancer progression known as HER2/neu. The purpose of this study is to determine if adding the vaccine ADXS31-164c into
the treatment protocol for dogs with osteosarcoma will be safe and improve efficacy of current standard therapies for
osteosarcoma in dogs.

Initial Evaluation for Participation:  
Blood and urine collection, chest x-rays, and abdominal ultrasound at UC Davis.

Procedures:
Most of the exams, tests, and procedures your pet will have within the first 15 weeks of the trial are part of the usual
approach for your dog’s treatment for osteosarcoma including blood collection, amputation of the affected limb and
carboplatin chemotherapy given once every three weeks for 4 doses followed by monitoring using chest x-rays once every
two months. Beyond that, dogs will receive/need:

  • Vaccine administration (3 doses)
  • Blood and urine samples collected throughout the trial
  • Tumor collection at the time of amputation
  • Body temperature and heart rhythm monitoring in the hospital for 8 hours following each vaccine administration
  • Rectal temperature monitoring at home 12 hours after the vaccine’s administration and reassessment the following
    day.

Benefits:
Benefits of standard therapy include removal of the painful cancerous tumor in your dog’s bone and delay of spread of
cancer by providing chemotherapy with carboplatin.

Owner Responsibilities:
If you allow your dog to participate in this study, you will be responsible for having the limb amputated at UC Davis, bringing
your dog to all required study appointments, recording their rectal temperature 12 hours after your pet receives each
vaccine, reporting any side effects, and covering costs of the initial examination with the UC Davis Oncology Service, the
screening diagnostic tests, which includes blood and urine collection and analysis, chest x-rays and abdominal ultrasound
and amputation, the four doses of carboplatin (as well as the associated tests, which includes bloodwork and chest x-rays),
any costs associated with management of side effects from the Standard Therapy Phase of this study (amputation and
carboplatin chemotherapy)..

Cost:
Following amputation and carboplatin, the study will cover the cost of follow-up examination, diagnostics, and all study costs
associated with the ADXS31-164c Vaccine Phase of the trial. If your dog experiences adverse events related to the vaccine,
a total of $500 will be allotted toward coverage of required care at UC Davis.

COLORADO
Study: 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
Recruitment Open until 12/31/2018

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

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 with osteosarcoma that does not have other life threatening diseases and has not received any
chemotherapy.  More specific inclusion criteria will be discussed with you during your evaluation appointment. Your dog will
have the vaccine in addition to standard of care therapy.

Treatment:
The vaccine will be given over 6 visits approximately 3 weeks apart in addition to 6 chemotherapy visits. If appropriate you
dog will also receive boosters every 6 months. 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 for study purposes.

Cost:
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. The costs for amputation/radiation and chemotherapy are not covered as part of this study and will be discussed
with you during your evaluation appointment. The study will cover only the cost of the vaccine at each of the six visits
(approximately $800 per dog for 6 vaccines) to a maximum of 100 dogs. A CBC is also covered by the study at each vaccine
visit (approximately $50). Additional costs will be discussed during your evaluation. 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..

MINNESOTA
Study: VIGOR Trial: Translational approach for development of a novel oncolytic immunotherapy for
osteosarcoma
Location:  University of Minnesota--St Paul, Minnesota
Contact:  Dr. Modiano (modiano@umn.edu) or Andrea Eckert, Senior Research Study Technician (612-625-3157 or
aleckert@umn.edu)
Recruitment Open until 11/01/2018

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, to 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, called VSV for short) which has been shown to be safe in a pilot study of eight dogs, and in two
separate studies totaling more than 20 pet dogs with cancer.

Dogs in this study will be chosen at random to have treatment with VSV or with a saline placebo. Neither the owners nor the
investigators will know which treatment the dogs are given. Dogs given placebo will still receive the standard of care
treatment of amputation and chemotherapy.

Eligible dogs will:
be diagnosed with osteosarcoma in a limb bone
weigh more than 44 lbs (20 kg)
be feeling well with no significant health concerns
be spayed or neutered
be up-to-date on vaccines, flea/tick prevention and internal pest control
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)
be willing to discontinue prednisone or other immunosuppressive drugs for two weeks prior to enrolling in the study

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

Day -1 tumor biopsy under anesthesia and baseline samples of blood, cheek, urine and stool

Week 1: dogs will spend the week at the Veterinary Medical Center (VMC). On Day 0 (Monday or Tuesday), dogs receive
treatment with VSV or placebo and will be housed in isolation, closely monitored by our team, for about 6 hours. We will
sample blood, cheek, urine and stool periodically to detect virus shedding and immune responses. On Days 1-3 we will
monitor the dog and take additional samples. Dogs go home on Day 3 (Thursday or Friday).
Recheck visits weekly for first month

Day 10 amputation occurs which is standard of care for dogs with osteosarcoma in a limb. The surgery is delayed to day 10
to give the VSV 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. We will 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.

NEW YORK
Study #1: Evaluating a targeted Telomerase vaccine in combination with a HER2 vaccine to stimulate
anti-tumor immunity and prolong survival times in dogs and cats with osteosarcoma, mammary cancer
and transitional cell carcinoma
Location: Veterinary Oncology Services, Middletown, NY.
Recruitment Open until 04/30/2020
For more information, please contact J Impellizeri, DVM, DACVIM at info@petcancerinformation.com, 845-205-2768

Description: Veterinary Oncology Services (VOS) at website (www.petcancerinformation.com) is investigating the benefit of
treating osteosarcoma, mammary (breast cancer) and transitional cell carcinoma in the dog and cat with this genetic DNA
telomerase cancer vaccine along with a genetic HER2 cancer vaccine using a plasmid encoding each target. The non-
funded study does not include a placebo.

Background: The use of a telomerase vaccine targets a protein whose enhanced expression is a common characteristic
present in 85-95% of both human and animal cancer cells. Telomerase is not expressed in most differentiated cells making
it an ideal target for cancer therapeutics. Upregulated telomerase allows for limitless replication thus tricking the cell to avoid
apoptosis (programmed cell death) in lieu of continued replication of a malignant oncogene. The vaccine may be used in
naive (non-treated) patients but we feel the effect will be limited to absent. HER2 is another target overexpressed in bone
cancer, breast cancer and bladder cancer.  Our goal is to combine these 2 treatments as a synergistic attack against not
only 1 target, but 2 different paths of cancer development. Concurrent use of vaccine with standard of care therapies is
encouraged and may be coordinated locally with your treating oncologist. Therapeutic vaccines are an important
progressive approach which, when combined with other therapies, can improve long-term control of cancer. A variety of
immunization technologies are being explored. Among them, genetic (DNA-based) vaccines are emerging as promising
methodologies to induce immune responses against a wide variety of tumor antigens, including telomerase.

Genetic Vaccines are not new but newer methods to improve greater DNA uptake has led to in-vivo electroporation (DNA-
EP) or electrogenetherapy (EGT)). Inoculating plasmid DNA encoding for a protein antigen by means of a simple
intramuscular or intradermal injection currently offers a vaccine approach that is easily performed, safe for host and
relatively inexpensive. However, target cells lack the co-stimulatory molecules needed as part of the CTL activation process,
therefore DNA vaccination is in general poorly efficient unless an inflammatory stimulus is applied in parallel. This mode of
administration through DNA-EP will allow maintenance of anti-tumor immunity. This approach uses brief electrical pulses that
create transient pores in the cell membrane, thus allowing large molecules such as DNA or RNA to enter the cell cytoplasm.
Immediately following cessation of the electrical field, these pores seal and the molecules are trapped in the cytoplasm
without causing cell death. The vaccine has published data in Europe (see below).

Exclusion criteria:
Patients with <1 month expected survival, concurrent severe co-morbidities.

Procedure: The vaccine is a series of 3 treatments (2weeks apart) with a DNA/plasmid administered via electrogenetherapy
(EGT). Each is administered every 2 weeks and there is an option for continued monthly boosters for those patients
maintaining remission. Specifically, the vaccines are administered under a short anesthesia via EGT. EGT is a technically
exciting mechanism of cancer vaccine delivery limited by a special generator that delivers the electrical impulse to open the
cell membrane. Clinical usage of the vaccine thus far has not shown any limiting side effects nor toxicities. No placebos are
involved. The study is unfunded. There are no guarantees and some patients may not respond.

If you are interested in this clinical trial, please go to
www.petcancerinformation.com and have your veterinarian fill out the
referral form.  Please fax or email this along with pertinent lab results.  If your pet is a candidate, the site will contact you
about the next step.

REFERENCES:
Electro-gene-transfer as a new tool for cancer immunotherapy in animals.Impellizeri JA, Ciliberto G, Aurisicchio L.Vet Comp
Oncol. 2014 Dec;12(4):310-8. doi: 10.1111/vco.12006. Epub 2012 Oct 25. Review.

A vaccine targeting telomerase enhances survival of dogs affected by B-cell lymphoma.Peruzzi D, Gavazza A, Mesiti G,
Lubas G, Scarselli E, Conforti A, Bendtsen C, Ciliberto G, La Monica N, Aurisicchio L. Mol Ther 2010 Aug;18(8):1559-67.
doi: 10.1038/mt.2010.104. Epub 2010 Jun 8.

Telomerase and HER-2/neu as targets of genetic cancer vaccines in dogs.Peruzzi D, Mesiti G, Ciliberto G, La Monica N,
Aurisicchio L.Vaccine. 2010 Feb 3;28(5):1201-8. doi: 10.1016/j.vaccine.2009.11.031. Epub 2009 Nov 26.

Safety and efficacy of a genetic vaccine targeting telomerase plus chemotherapy for the therapy of canine B-cell lymphoma.
Gavazza A1, Lubas G, Fridman A, Peruzzi D, Impellizeri JA, Luberto L, Marra E, Roscilli G, Ciliberto G, Aurisicchio L. Hum
Gene Ther. 2013 Aug;24(8):728-38.

Study #2: Evaluating a targeted her2/neu cancer vaccine for the stimulation of anti-tumor immunity and
prolonging survival times in dogs with osteosarcoma (bone cancer).
Location: Veterinary Oncology Services, Middletown, NY.
Recruitment Open until 01/01/2020
For more information, please contact J Impellizeri, DVM, DACVIM at info@petcancerinformation.com, 845-205-2768

Description: The study will test whether an adenovirus based vaccine followed by a DNA plasmid administered via
electrogenetransfer can elicit anti-tumor immunity and increase survival times. Most dogs undergo amputation and
chemotherapy for bone cancer with median survival of about 1 year due to metastatic spread to the lungs. The vaccine will
be an additional therapy to standard of care treatment. Up to 60% of dogs with osteosarcoma will express the Her2/neu
genetic marker. Telomerase and HER-2/neu as targets of genetic cancer vaccines in dogs. Peruzzi D, Mesiti G, Ciliberto G,
La Monica N, Aurisicchio L. Vaccine. 2010 Feb 3;28(5):1201-8. Epub 2009 Nov 26.

The vaccine targets this Her2/neu pathway of tumorigenesis allowing the body's immune system to battle the cancer in
addition to standard therapies. PROCEDURE: Vaccine is a series of 5 treatments (2 adenovirus/Her2/neu) followed by 3
DNA/plasmid administered via electrogenetherapy (EGT). Each is administered every 2 weeks and there is an option for
continued monthly boosters for those patients maintaining remission. The first two (2) adenovirus vaccines (prime) are
administered via simple intra-muscular injection. The last three (3) of the series (boosters) are administered under a short
anesthesia via EGT. No placebos are involved and the study is unfunded and under USDA regulations. This immunotherapy
is an extension of the center's telomerase cancer vaccine that has shown success against canine lymphoma in Europe.
There is no guarantee and some patients may not benefit.

Inclusion Criteria:
Diagnosis of osteosarcoma, Travel to other locations across the U.S. is possible for an additional fee

Exclusion criteria:
Patients with <1 month expected survival, concurrent severe co-morbidities.

If you are interested in this clinical trial, please go to
www.petcancerinformation.com and have your veterinarian fill out the
referral form.  Please fax or email this along with pertinent lab results.  If your pet is a candidate, the site will contact you
about the next step.

PENNSYLVANIA
Study: Evaluation of progression-free survival and immunological response to a vaccine administered to
dogs receiving definitive surgery and adjuvant carboplatin chemotherapy for spontaneous appendicular
osteosarcoma

Location: Hope Veterinary Specialists | Malvern, Pennsylvania.
Recruitment Open until 12/31/2018
C
ontact: Phone: 610-296-2099

Description: Osteosarcoma is the most common primary bone tumor in dogs. Surgery (typically amputation) followed by
carboplatin chemotherapy is considered the standard of care treatment, with an associated median survival time
approaching 1 year.  Novel therapies are still needed to extend remission and survival.

The objectives of this study are to evaluate the safety and efficacy of a novel immunomodulator in dogs as an adjunct
treatment for osteosarcoma. Dogs will undergo preliminary staging tests including initial consultation, physical examination,
lab work, thoracic radiographs, and tumor biopsy/immunohistochemistry to determine trial eligibility.  All eligible dogs will
undergo amputation of the affected limb followed by carboplatin chemotherapy every 3 weeks for 4 doses.  Dogs will be
randomized to receive either immunotherapy or placebo in conjunction with carboplatin chemotherapy. The initial
immunotherapy treatment series or placebo (4 injections) will be administered every 2 weeks.  Boosters will occur one month
following completion of the initial series and then every 3 months thereafter until study end.

Preliminary staging tests, carboplatin treatments, immunotherapy/placebo treatments, and follow-up visits after completion
must be performed at HopeVS.  Ideally, amputation would be performed at HopeVS so that biopsy samples can be sent
directly to the central lab for special testing (IHC for Her2) to rapidly determine patient eligibility, as treatment must be
initiated at day 14 post-surgery. If amputation is to be performed elsewhere, please coordinate with the study site so that
surgical samples can be sent to the appropriate lab on the day of surgery.

Dogs will remain in the study until osteosarcoma recurrence/metastasis is documented.

Inclusion criteria:
Dogs must be at least 2 years of age. Dogs must weigh >25 kg. Dogs must have measurable disease amenable to limb
amputation with no evidence of distant metastasis (tumor spread). Dogs must have histologically confirmed, HER2-positive
osteosarcoma of the appendicular skeleton. Dogs must reside with their owners within driving distance of HopeVS. Owners
must sign a consent form including consent for necropsy if an unexpected death occurs during the study.


Exclusion criteria:
Prior treatment for OSA including surgery, chemotherapy, radiation therapy and/or bisphosphonates. Dogs receiving long-
acting systemic steroids within 30 days prior to study. Dogs with recurrent tumors. Dogs with a history of medical illness
other than osteosarcoma that, in the opinion of the Investigator, could compromise response to the vaccine or interfere with
evaluation of its efficacy. Dogs with post-surgical healing complications that, in the opinion of the Investigator could interfere
with the safety evaluation of the vaccine. Dogs that are fractious and unable to be handled for treatment.  Dogs whose post-
surgical tumor histopathology is not consistent with osteosarcoma. Dogs whose post-surgical tumor immunohistochemistry is
not consistent with positive HER2 expression.

Cost: Partially funded (owner cost >$1000).
PET CANCER CENTER
Comprehensive guide to cancer diagnosis and treatment in cats and dogs
© 2007 Pet Cancer Center. ALL RIGHTS RESERVED.
Last updated 6/20/2018
Please take our short survey to help us understand pet owners' perception of clinical trials.
Clinical trials for bone cancer (osteosarcoma) in dogs
Open clinical
trials for dogs
Find clinical trials for specific tumor types in dogs: