Clinical Trials for Osteosarcoma

There are two trials on offer for dogs with osteosarcoma.

 

TRIAL 1 Study Description:

Ten dogs with radiographically visible osteosarcoma (OS) metastases will be entered into an open clinical trial evaluating the effectiveness of combined therapy with toceranib (Palladia) and losartan.  Dogs will receive every other day doses of toceranib based on current dosing guidelines for this drug in dogs (2.75 mg/kg EOD). Losartan is administered at 10 mg/kg BID, as our PK and PD studies indicate that this dose is effective for inhibition of monocyte migration in dogs. The trial is intended to last 24 months.  Treatment effects on lung tumor growth will be monitored by every 2 month radiographs. Blood will also be collected at 2-month intervals to assess effects of treatment on circulating myeloid suppressor cells and immune suppressive cytokines (IL-10, VEGF) and relevant chemokine concentrations (MCP-1, IL-8).

Location/Study Sites:

Colorado State University

Study Type:

Interventional

Primary Study Contact:

Kristen Weishaar

970-297-4071

Kristen.Weishaar@colostate.edu

Inclusion Criteria:

  • Dogs that have had surgery to remove their primary tumor and have measurable metastatic disease on chest radiographs

  • No significant abnormalities on blood work

  • Two week washout from chemotherapy or radiation therapy

Exclusion Criteria:

  • No concurrent treatment with any immunosuppressive agent

  • No pre-existing allergic airway disease or significantly low heart rate

 

TRIAL 2 Study Description:

Up to 18 dogs will be enrolled in this phase 1 study. The purpose of the study is to determine the maximum tolerated dose and efficacy of an immunotherapy protocol against metastatic osteosarcoma in the lungs. 

Location/Study Sites:

UC Davis, VMTH 

Study Type:

Interventional

Primary Contact:

OncologyClinicalTrials@ucdavis.edu

(530) 322-8339

Inclusion Criteria:

  • Dogs > 1 year

  • Radiographs consistent with metastatic disease from patients with a cytological or histopathological diagnosis of osteosarcoma.

  • Body Weight > 10 kg

  • VCOG-CTCAE 1.1 performance score of 0 or 1

  • Any clinically significant grade 2 or higher hematologic or biochemical abnormality.

  • At least one lung lesion measuring at least 1cm on radiographs

Exclusion Criteria:

  • Dogs with pulmonary lesions less than 1cm

  • Dogs unable to undergo sedation for chest films

  • Owner unwilling to administer inhaled IL-15 twice daily and/or dog unable to tolerate twice daily nebulization

  • Chemotherapy within 2 weeks of day 0

  • Immunotherapy or radiation therapy within 4 weeks of Day 0

  • VCOG-CTCAE 1.1 performance score of 2 or higher

  • Concurrent therapy (NSAIDS acceptable if needed for pain control and patient has been receiving for 2 weeks or more)

Cost Structure:

  • Costs NOT Covered by Study - Owners are responsible for eligibility screening which may include initial or recheck office examination, bloodwork including CBC/Chemistry panel/UA, thoracic radiographs, and confirmed diagnosis of Osteosarcoma;

  • Costs Covered by Study-Once determined eligible and the pet is enrolled, the study will cover the cost of appointment fees, blood sampling, sedation, fine-needle aspirates, thoracic radiographs, and study related IL-15, PPE, and procedures. The study will provide the use of the nebulizer, however, this will need to be returned at the end of the treatment;

  • Costs Covered for Adverse Events-If the pet experiences adverse event(s) as a result of taking part in this study, and is in need of medical treatment, the study sponsors will offer to pay for medical treatment for injury/side effects up to $2000. The study can ONLY pay for costs of therapy incurred at the UC Davis Veterinary Medical Teaching Hospital. Costs associated with treatment beyond $2000 will be at the expense of the owner.

Video Link:

Inhaled IL-15 Immunotherapy to treat Lung Metastases in Dogs

Study Pages Link (account required):

https://studypages.com/study/1402/preview/

https://studypages.com/study/1662/preview/

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