OSTEOSARCOMA

ELIAS Cancer Immunotherapy (ECI®) combined with surgery as a treatment for Osteosarcoma cancer in dogs

Craig A Clifford DVM, MS, DACVIM (Oncology), Kristen Kicenuik, DVM, DACVIM (Oncology), Christine Mullin, VMD, Diplomate ACVIM (Oncology), and Rebecca Risbon, VMD, DACVIM (Oncology)
Investigators

————

Study Description

Hope VS is currently enrolling cases for a new clinical trial for dogs with osteosarcoma (long bone). The study is sponsored by ELIAS Animal Health to evaluate its ELIAS Cancer Immunotherapy (ECI®)—a vaccine-enhanced adoptive cell therapy—combined with surgery as a treatment for cancer in dogs. ELIAS has developed a unique immunotherapy treatment protocol that may permit the dog’s immune system to attack its own cancer cells. ECI has demonstrated effectiveness in clinical trials in both canines and humans while avoiding or minimizing the need for chemotherapy or radiation treatment.

Trial Summary

  • Trial enrollment is required prior to amputation (affected limb must be intact)
  • Treatment includes either ECI immunotherapy or carboplatin chemotherapy
  • Patients must complete a 7-11 week treatment regimen and return for quarterly follow-up visits throughout the 18-month trial
  • Study sponsor will cover treatment costs (including consult with oncologist, radiographs, lab work, ECI immunotherapy or carboplatin chemotherapy treatment, and their administration)

Inclusion Criteria

  • Appendicular osteosarcoma with the limb still in place
  • Patient is determined to be in sufficiently good health overall to undergo and complete the treatment schedule
  • Is not currently pregnant or lactating
  • Has not previously received any treatments for its cancer
  • Does not have metastatic disease (tumor spread) at the time of diagnosis
  • Is not currently on immunosuppressive drugs
  • Is not currently taking any supplements, herbal products, or other natural remedies for its cancer or other health-related issues
  • Does not have a second malignancy
  • Must weigh at least 15 kg
  • Owner/guardian is willing and able to take the dog to all scheduled clinic visits during the treatment schedule, as well as the follow-up visits

Client Benefits

ELIAS is providing financial assistance that will substantially cover the costs of participation and treatment in the trial.

————

To learn more about this therapy, and to see if your dog or your canine patient may be a good candidate please contact us.

P: (610) 296-2099

E: [email protected]


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), Kristen Kicenuik, DVM, DACVIM (Oncology), Christine Mullin, VMD, Diplomate ACVIM (Oncology), and Rebecca Risbon, VMD, DACVIM (Oncology)
Investigators

————

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.

————

For more information, please contact us:

P: (610) 296-2099

E: [email protected]