Oral Melanoma: Investigating a New Monoclonal Antibody
Amber Winter, CVT
Research Professional 2
[email protected]
612-624-1352
Study title
A multicenter, placebo-controlled field study evaluating monoclonal antibody in dogs with malignant oral melanoma
Purpose of study
This study is designed to confirm the effectiveness and safety of a conditionally approved product in dogs with naturally occurring cancer causing measurable tumors to obtain full licensure.
Eligibility criteria
Dogs must:
- be ≥ 1 year of age
- have a body weight ≥ 3 kg
- have cytological or histopathological diagnosis of stage III malignant oral melanoma
- have at least one measurable lesion with a longest diameter of ≥ 10 mm (≥15 mm for nodal lesions) at baseline
- have a Veterinary Co-operative Oncology Group (VCOG v1.1) Performance Score of 0 or 1 [0 = normal activity; 1 = mild lethargy over baseline, diminished activity from pre-disease level]
- not have prior surgery to remove masses or, if they have, the measurable disease remains to meet inclusion criteria and the surgery was performed no less than 14 days prior to enrollment
- not have melanoma confined only to the lip
- not be pregnant, lactating, or likely to become pregnant
- not be in another interventional therapy study at the same time
Discuss current medications prior to screening; a wash out period may be needed for several prior to the start of the trial.
Procedures
Screening visit: Owner to fill out consent, demographics/history forms and Quality of Life (QOL) assessment. Procedures performed will include a physical exam (PE); blood and urine collected; chest x-rays and tumor biopsy.
If the patient is enrolled, there will be 14 study visits, occurring every 14 days for approximately 26 weeks.
Study visits 1, 4, 6, 8, 10, 12: appointments will include a PE and QOL assessment; study treatment administered via intravenous infusion and post-treatment monitoring.
Study visits 2, 3, 5, 9, 11, 13: appointments will include the above study visits; blood and urine will also be collected.
Study visit 7-mid point: appointment will include a PE, QOL assessment, blood and urine collected, chest x-rays, study treatment administered.
Study visit 14-end visit: appointment will include a PE, QOL assessment, blood and urine collected, chest x-rays, tumor biopsy preformed.
Costs
There is no cost to you for participating in this study. All costs associated with the study visits listed above will be covered by the study.