Study Description:
This is a phase I study and will enroll up to 18 dogs.
Location/Study Sites:
UC Davis, VMTH
Study Type:
Interventional
Primary Study Contact:
Teri Guerrero
530-752-0215
tguerrero@ucdavis.edu
Inclusion Criteria:
- Dogs > 1 year old
- Body Weight > 10 kg
- VCOG-CTCAE 1.1 performance score of 0 or 1
- Confirmed diagnosis of malignant melanoma on cytology or histopathology
- Radiographs consistent with metastatic disease with at least one lung lesion measuring at least 2 cm on radiograph
Exclusion Criteria:
- Dogs with pulmonary lesions less than 2cm
- Dogs unable to undergo sedation for chest films
- Owner unwilling to administer inhaled IL-15 twice daily and/or dog unable totolerate 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 or Melanoma
- 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.