Clinical Trial

Study to evaluate the safety and efficacy of tigilanol tiglate in the treatment of grey horse melanomas

Department: Oncology Service

Overview

Title:  Safety and potential efficacy of 20% v/v tigilanol tiglate (0.2 mg/cm3 lesion volume) in the treatment of grey horse melanomas

Investigators:
Corey Saba, DVM, DACVIM (Oncology faculty)
Jarred Williams, DVM, DACVS-LA (Equine faculty)

If interested, please have your primary veterinarian request additional information through the UGA Oncology service by calling the referral coordinator at 706-542-3221.

Study description :  The objectives of this study are to evaluate the safety and potential efficacy (defined as decrease in tumor size) of tigilanol tiglate (20%V/V), for treatment of grey horse melanomas

Inclusion criteria:

  1. Grey horses must have suspected or confirmed measurable melanomas.
  2. Single or multiple melanomas (up to 3 per horse) may be treated as long as tumor volume is 2 cm3 – 10 cm3.
  3. Horses must be otherwise healthy without concurrent disease, especially ongoing conditions (e.g. gastric ulceration) where the use of NSAIDs is contra-indicated.
  4. Prior treatment, including the Oncept vaccine, is acceptable but must be discontinued ≥ 6 months prior to study enrollment.
  5. Owners must sign a consent form.

Horses will undergo preliminary staging tests including initial consultation and physical examination.  Once deemed eligible for inclusion, the intent will be to inject tigilanol tiglate (20%V/V) into the tumor(s).  Depending upon response, injections may be repeated up to 3 times. At several time points following treatment (for up to 2 years), owners will be asked to submit photos of the tumor to UGA for assessment of treatment response. In some instances, the horse may be required to return to UGA for re-evaluation.

Tigilanol tiglate (20%V/V) will be provided at no cost as part of this trial. Costs of study related office visits, lab work, and ancillary medications such as NSAIDs and sedatives will also be covered by the Sponsor.

Duration of study: The study is currently OPEN.  Duration of the study is until progression in tumor size, or a total of 24 months.

Potential benefits to veterinary medicine: Successful demonstration of efficacy and safety of this treatment may lead to large scale clinical trials and may provide a valuable option for veterinarians and horse owners seeking an alternative to surgical removal of grey horse melanomas.