Novel Therapy with LSD-1 inhibitor for Cats with Oral Squamous Cell Carcinoma

Patient Disease:

Feline Oral Squamous Cell Carcinoma

Study Name:

Novel Therapy with LSD-1 inhibitor for Cats with Oral Squamous Cell Carcinoma

Purpose of the study:

  • To establish the dosing, safety and anti-cancer properties of a novel oral drug called a lysine-specific demethylase 1 (LSD-1) inhibitor when given to cats that have been diagnosed with oral squamous cell carcinoma

Primary Eligibility Criteria:

  • Cats with a confirmed diagnosis of oral squamous cell carcinoma with tumor size at least 1.5 cm and amenable to biopsy
  • Weigh at least 2.5 kg (5.5 lb)
  • Good function of liver and kidneys, acceptable blood cell counts, and free of severe underlying disease
  • Cats must be amenable to handling without sedation or significant stress
  • Owners must be able to administer oral medications to their cat
  • Two-week washout from chemotherapy; no prior radiation therapy
  • Pets must come to CSU for all visits related to the clinical trial

Study Protocol:

  • Within 7 days of enrollment, cats must have a complete blood count, chemistry profile, urinalysis, and chest x-rays to determine study eligibility
  • Cats will first receive a low dose of the study medication and have serial blood samples collected afterwards; these findings will be used to determine the dose to be given throughout the study
  • Cats will receive the study medication by mouth once daily for the duration of the study (21 days)
  • Cats will be rechecked weekly during the study for exam, tumor measurements, and blood work/urinalysis
  • Tumor biopsies will be performed under heavy sedation/anesthesia prior to starting the study medication and at Day 21, or when their disease progresses
  • Some cats will have PET/CT imaging performed at Day 0 and Day 21
  • Study participation is complete after the Day 21 visit

Owner Responsibilities:

  • Follow appointment schedule required by study protocol
  • Administer study medication at home by mouth once daily
  • Costs associated with tests to obtain diagnosis of squamous cell carcinoma and any other tests recommended by your pet’s oncologist

Financial Incentives:

  • The study will cover all costs associated with the screening and study visits, including hospitalization during the day, cost of supplies, and medications given during these visits
  • Once cats have completed the study, owners will receive a $2,000 credit to their pet’s account at the VTH to be used for future treatment
  • Study will also pay up to $1,000 towards any complication or side effects from the study; treatment needs to be provided at CSU VTH for this to occur

If you have further questions about any of our clinical trials, please submit an online consult form. Your consult will then be directed to our trials team. Requests are typically returned within 5 business days.

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