Additional Field Safety Testing of Canine Osteosarcoma Vaccine, Live Listeria Vector COV-LLV (USDA Product Code 9243.R0)

Purpose of Study: 

The usual treatment of osteosarcoma, painful bone tumor found in the limbs of dogs is limb amputation followed by chemotherapy (4-6 doses of carboplatin intravenously once every 21 days).

The purpose of this study is to collect additional safety data for the USDA-conditionally licensed, Canine Osteosarcoma Vaccine, Live Listeria Vector when administered three times to dogs with osteosarcoma after they have completed a protocol consisting of limb amputation and intravenous carboplatin therapy. In a previous study, COV-LLV was safe when administered three times to a limited number of dogs with OSA.  A statistically significant improvement in long term survival was noted.  As an open study, all enrolled dogs will be treated with COV-LVV.

Eligibility: 
  1. Dogs > 1 year of age weighing at least 2 kg.
  2. Histopathologic or cytologic diagnosis of osteosarcoma is required.
  3. Dogs with a diagnosis of appendicular osteosarcoma, previous limb amputation followed by 4-6 doses of either carboplatin or doxorubicin are eligible.  
  4. Dogs need to be ambulatory for daily activities like eating, defecation, and appropriate urination.
  5. Assessment at the screening visit includes medical history, physical exam, routine blood tests (complete blood count, serum biochemistry), and a urinalysis. In addition, 3-view thoracic radiographs will be performed to confirm absence of gross evidence of tumor spread to the lungs.
Exclusion: 

1. Participants will have no clinically significant or uncontrolled diseases such as, abnormalities identified in pre-screening lab tests indicating serious kidney or liver disease.
2. Evidence of pulmonary metastases on 3-view thoracic radiographs
3. Prior immunotherapy for osteosarcoma
4. Dog is pregnant, lactating or likely to become pregnant

Client Responsibilities: 

1.   Participation includes a screening visit, three treatment visits 20 to 24 days apart (Visits 1-3) and one final follow-up visit 21 days after the third and final vaccine treatment (Visit 4). The screening visit and visit 1 may be done on the same day.

2.    Dogs will be present in the hospital for about 8-9 hours on treatment days for prehydration time with premedications (approximately 2 hours), intravenous treatment infusion (approximately 30 minutes), and post-treatment monitoring (approximately 6 hours).

3.    Owner participation includes daily assessment of their dog for activity, appetite, vomiting, diarrhea and any other relevant observations. These are recorded in a provided written diary and reviewed at each visit.

Client Benefits: 

You will be responsible for any costs associated with the normal course of treatment. However, some compensation is provided. 

A total possible credit to your dog’s bill of $1,350 will be made, if your dog meets the requirements for entry into the study and completes the study including the follow-up visit.

Treatment costs associated with a serious adverse event related to the vaccine may be covered by the study sponsor.

Contact: 

Dr Leslie Fox: 515-294-4900

Dr Chad Johannes: 515-294-4900