Trials for Malignant Melanoma

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.

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