Title: A multicenter, placebo controlled field study evaluating a novel investigational veterinary product (IVP) in dogs with oral melanoma
Investigators:
Corey Saba, DVM, DACVIM (Oncology faculty)
If interested, please have your primary veterinarian request additional information through the UGA Oncology service by calling the small animal referral coordinator at 706-542-5362.
Study description:
This multicenter, masked, placebo-controlled, randomized clinical trial is designed to evaluate the safety and potential efficacy of a novel IVP for potential treatment of oral melanoma (not confined to the lip) in dogs. Dogs must have a cytology or biopsy confirmed diagnosis of stage III oral melanoma to be eligible for participation in this study. In addition, the following conditions must be met:
Inclusion criteria:
- Dogs must weigh ≥ 3 kg (6.6 lbs.) and be otherwise healthy
- Dogs must have at least one measurable lesion (tumor) with a longest diameter of ≥ 1 cm and/or one measurable lymph node with a short axis of ≥ 1.5 cm.
- Prior surgery is allowed (if performed at least 14 days prior to enrollment) as long as measurable disease remains which meets above criteria. Prior treatment with ONCEPT® Canine Melanoma Vaccine is not allowed.
Dogs will undergo clinical screening at UGA. Preliminary diagnostics will include initial consultation, physical examination with target lesion (tumor) measurements, complete blood count (CBC), serum biochemical profile, urinalysis, T4, and thoracic radiographs.
All routine costs associated with the study including initial screening diagnostics (excluding confirmation of cancer diagnosis), office exams, scheduled lab work, treatments with the IVP or placebo and management of treatment related side effects during the study period will be paid by the study sponsor.
Duration of study and Owner Requirements:
The study is currently enrolling. Qualified dogs and their owners should expect to stay in the study for approximately 6 months and have 15 scheduled visits every two weeks at UGA. Owners must sign a consent form and will also be required to document study associated observations as appropriate.
Potential benefits to veterinary medicine:
This trial is expected to provide valuable information about the safety and efficacy of a novel treatment for dogs with certain naturally occurring cancers. The ultimate goal is to improve the quality of life of dogs with cancer.
