KANSAS STATE UNIVERSITY
Study: Anti-cancer vaccine (MediVet Biologics K9-ACV) for dogs with any malignant tumor
Location: kansas State University
For more information, please contact Misty Bear, Clinical Trials Coordinator, at (785)532-3046 or ClinicalTrials@vet.k-state.
edu

Eligibility: Dogs, ≥5kg in size, with an adequate health score diagnosed with any malignant tumor type >3-4cm3 in size may
be eligible for this study. There may be a strong presumptive diagnosis of malignancy based on history, clinical signs and
imaging, but the diagnosis must ultimately be confirmed by histopathology before enrollment. The dog must have no
evidence of metastatic disease, based on chest x-rays and abdominal ultrasound, at the time of surgery and/or the initial
dose of the vaccine.  Enrollment must be completed prior to surgery. Surgical excision of the tumor must be part of the dog’
s initial treatment plan to be enrolled in this trial.

Dogs having received prior radiation therapy and/or prior chemotherapy would not be eligible for enrollment.  Non-steroidal
anti-inflammatory therapy (NSAIDs) and/or  corticosteroid therapy will be allowable with a minimum washout period of 72
hours prior to enrollment.

Summary: If enrolled into this study, your dog’s own tumor will be used to generate a very specific anti-cancer vaccine.
Over the last few decades, improved tumor antigen identification and isolation, adjuvant development and delivery vehicle
design, as well as identification of the most appropriate vaccine recipient candidates, have further invigorated the cancer
vaccine research and development pipeline.

Cancer vaccines represent a form of active immunotherapy, whereby they exert an antitumor effect by engaging the host
immune response.

The vaccine system being employed in this study was developed by researchers at the University Of Kentucky College Of
Medicine, in conjunction with MediVet Biologics, and was modeled on a vaccine system previously developed by the same
research group at the University of Kentucky and investigated in human lung cancer patients.


Objective: To evaluate the efficacy of a newly formulated anti-cancer vaccine (K9-ACV, MediVet Biologics) in dogs
diagnosed with a spectrum of naturally-occurring cancers.  We will be measuring your dog's systemic immunologic anti-
tumor response to the vaccine. It is hypothesized that this vaccine will elicit an antitumor immunologic response resulting in
improved disease-free intervals and median survival times in dogs with various tumor types without compromising quality of
life.


Requirements: After your dog is enrolled into this study, surgery will occur at the VHC to debulk the primary tumor. Part of
the tumor tissue will be submitted for histopathologic diagnosis, grading and surgical margin assessment, and the
remainder (minimum 5g) for vaccine formulation by the team at the University of Kentucky/MediVet Biologics.  While the
vaccination series cannot start until 7-14 days after the initial surgery, as this is how long the vaccine formulation takes,
approval of enrollment, accompanied by owner informed consent, is required prior to surgery. In all cases of enrolled dogs,
the surgical procedure to be performed would be considered standard of care treatment of that particular tumor type.

Following surgery, enrolled dogs will be placed into one of two treatment groups at the owner’s request; the first receiving
simply the vaccination series, and the second receiving the vaccination series in combination with the appropriate standard
of care chemotherapy.

If post-operative chemotherapy is elected by the owners, it will be performed by VHC Oncology Service. Recheck exams
and blood work are required for monitoring of the patient’s immune response to the vaccine, as well as periodic monitoring
chest x-rays and ultrasound. All study activities must occur at the VHC.

Cost: This study covers the cost of vaccine formulation and administration, as well as recheck exams and blood work for
enrolled dogs. Periodic monitoring chest x-rays and ultrasound are also covered by the study for up to one year. Owner is
responsible for the cost associated with pre-enrollment work-up/staging, which includes chest x-rays, abdominal
ultrasound, blood work and urinalysis.


WISCONSIN
Study: AuroLase Therapy for the Treatment of Solid Tumors in Cats and Dogs
Location: University of Wisconsin, Madison
For more information, please contact Ricardo Fernandez (rfernandez4@wisc.edu, 608-263-7600)

Eligibility: Dogs or cats that have been diagnosed with a malignant tumor that is easily accessible.

Summary: AuroLase Therapy uses a therapeutic medical device designed to selectively destroy solid tumors using near
infrared illumination from a laser. AuroLase Therapy is comprised of three components: 1) an off-the-shelf near infrared
laser source, 2) an off-the-shelf interstitial fiber optic probe for delivery of the laser energy to a site near or inside the
tumor, and 3) the investigational gold nanoparticles (AuroShell particles), a near infrared absorbing, physiiologically inert
material designed to absorb and convert laser energy into heat. Intravenously administered AuroShell particles have
previously shown efficacy and high selectivity over surrounding healthy tissues in a variety of animal models .

Requirements: Required study visits include pretreatment, day 0 (which may be the same day as pretreatment), day 1, 14
and 28. A physical examination and a small blood sample will be collected pretreatment and days 1, 14 and 28. The
AuroShell particles will be administered intravenously on study day 0. On study day 1, your pet will be anesthetized for
approximately 30 minutes for application of the laser treatment. While under anesthesia, a tumor biopsy will be performed.
Tumor biopsies will be repeated on study day 14 and 28 under mild sedation. Your pet may experience some local pain at
the site of the biopsy and laser application. If this occurs, the clinician will prescribe pain medication. After study day 28 (or
sooner if your pet is removed from this study for any reason), the study will be completed and the oncology clinician will
discuss additional follow up and treatment options with you.

Cost: The study will cover all costs related to AuroLase Therapy treatment and required recheck examinations, blood tests
and tumor biopsies. In addition, a gift of $250 will be applied as a credit to your UW Veterinary Care account
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Last updated 2/18/2017
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