CLOSED--Anti-cancer vaccine for dogs with any malignant tumor--CLOSED
Anti-cancer vaccine (MediVet Biologics K9-ACV) for dogs with any malignant tumor
Purpose and Brief Study Description:
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.
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.
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.
What does enrollment into this trial involve?
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.
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.
Please contact Misty Bear, Clinical Trials Coordinator, at (785)532-3046 or ClinicalTrials@vet.k-state.edu for more information about this study.