OSTEOSARCOMA

TRIAL 1

Optimizing Novel Immunotherapy Combinations Targeting the Tumor Microenvironment in Canine Spontaneous
Osteosarcoma

New drug treatments for osteosarcoma (bone cancer) with spread to the lung

Craig A Clifford DVM, MS, DACVIM (Oncology), Kate Vickery, VMD, MS, DACVIM, CVA; Christine Mullin, VMD, Diplomate ACVIM (Oncology); Kristen Kicenuik, DVM, DACVIM (Oncology)
Investigators

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Study Description

The purpose of this clinical trial is to evaluate the activity of new immunotherapy agents for the treatment of osteosarcoma that has spread to the lungs. The ultimate goal is to find drug combinations that either stop the growth of tumor spread or that actually shrink the spread by stimulating the immune system to control the cancer.
Your dog will undergo several blood tests/diagnostics prior to and during the course of treatment to monitor blood counts and collect plasma/blood for additional genetic analyses. These blood draws amount to approximately 2 tbsp. of blood at each visit. Your dog’s treatment for osteosarcoma will involve the administration of two drugs orally at home to help control the cancer: oclacitnib (Apoquel) and ladarixin in combination with the IV chemotherapy agent doxorubicin.

Inclusion Criteria

• At least one year old on Day 0 and weigh at least 10 kg (22 lbs)
• All dogs must have had surgical resection of the primary tumor with a histologically confirmed diagnosis of OSA.
• All dogs must have measurable pulmonary metastatic disease, documented by thoracic radiographs.
• Prior chemotherapy (or other specific therapy for OSA) or any other anti-cancer therapy is acceptable with a 2-week washout from prior treatment.
• Dogs must have adequate organ function as indicated by standard laboratory tests: (hematology (CBC), clinical chemistry and urinalysis).
• The animal must have a performance status of either 0 or 1 on Day 0, according to the modified ECOG Performance Scheme.
• The Owner must have provided written, informed consent prior to enrolling in the study.

Exclusion Criteria

• Dogs that have received chemotherapy within 2 weeks of Day 0.
• Previously received Doxorubicin
• Concurrent malignancy, or other serious systemic disorder incompatible with this study.
• Dogs that are on homeopathic/alternative therapies for OS. These treatments should be discontinued on Day -1. Supplements such as chondroitin sulphate, vitamins, essential fatty acids, and glucosamine are permitted during the trial period. Pain medications such as opioids and NSAIDs are permitted at the discretion of the clinician provided they were also administered prior to the development of metastases.

Client Benefits

The study will cover all diagnostics (bloodwork, x-rays, etc) and treatments (oral and IV drugs) associated with the osteosarcoma while your dog is enrolled in this study as well as the management of any study-related side effects up to a total of $4000. This will cover treatment for approximately 4-6 months; after this point in time, if your dog is
doing well and continues on therapy, costs for monitoring (bloodwork, x-rays) will not be covered, although the drugs (Apoquel/Ladarixin) will be provided at no cost. Except for the specific financial support described here, any tests or procedures unrelated to this study including treatment of conditions unrelated to the osteosarcoma are your responsibility.

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For more information, please contact us:

P: (610) 296-2099

E: [email protected]

 

TRIAL 2

Additional Field Safety Testing of Canine Osteosarcoma Vaccine, Live Listeria Vector.

Craig A Clifford DVM, MS, DACVIM (Oncology)
Primary Investigator

Kate Vickery, VMD, MS, DACVIM, CVA; Christine Mullin, VMD, Diplomate ACVIM (Oncology); Kristen Kicenuik, DVM, DACVIM (Oncology)
Co-Investigators

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Study Description

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. Potential dogs are screened 1 month after completion of chemotherapy. If deemed eligible, patients are administered COV intravenously once every 3 weeks for up to 3 treatments. Patients are kept in hospital overnight following treatment for close monitoring and management of any adverse events.   

Inclusion Criteria

  • Signed Owner Informed Consent
  • Client-owned dog > 1 year of age
  • Body weight ≥ 2 kg
  • Histopathologic or cytologic diagnosis of osteosarcoma
  • Amputation of the affected limb followed by a completed chemotherapy regimen
  • 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 Criteria

  • Clinically relevant abnormalities on lab work
  • Evidence of pulmonary metastases on 3‐view thoracic radiographs
  • Prior immunotherapeutic treatment for osteosarcoma
  • Any uncontrolled medical condition (including other concurrent malignancy) that may be disruptive to the intent and objectives of the study
  • Dog is pregnant, lactating or likely to become pregnant
  • Dog is participating in another study
  • Dog may not be available for the entire study duration

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Funding

The majority of study related costs (i.e. lab work, radiographs, treatment administration, hospitalization fees) are the responsibility of the owner. A small amount of funding is provided toward cost of the vaccine.

Duration of Study

Enrollment opportunities are limited and will terminate when the target enrollment is filled.

Potential benefits to veterinary medicine

Following the standard of care treatment, COV may improve disease-free interval and overall survival time in dogs with osteosarcoma.

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For more information, please contact us:

P: (610) 296-2099

E: [email protected]