Feasibility of radiotherapy combined with MT0321 intravenous administration for canine intranasal adenocarcinoma

The University of Florida College of Veterinary Medicine is currently recruiting dogs who have been diagnosed with nasal adenocarcinoma. This investigational trial is to better understand how the agent sulfoquinovosylaclypropanediol (SQAP) may help make radiation therapy more effective in the treatment of nasal cancer in dogs. This study will be a small preliminary study to evaluate the feasibility of the protocol for a future, larger study.

Enrollment Status: Currently Enrolling

  • Inclusion Criteria: Dogs who meet the following criteria may be eligible for our study
    • Histologically diagnosed Adams Stages 1-3 intranasal adenocarcinoma amenable to radiotherapy
      • Stage 1: Confined to one nasal passage, paranasal sinus, or frontal sinus with no bone involvement beyond the turbinates
      • Stage 2: Any bone involvement beyond the turbinates, but no evidence of orbital, subcutaneous, or submucosal mass
      • Stage 3: Orbit involvement, nasopharyngeal, or submucosal mass
      • Stage 4: Tumor causing lysis of the cribriform plate
    • No prior chemotherapy, radiotherapy, or surgical therapy for this tumor
    • Expected survival of 3 months or greater
    • Age of at least 1 year
    • Body weight of at least 5 kg
    • Adequate organ function on standard biochemistry, complete blood count
    • No clinically significant abnormalities including vital signs and physical examination
    • Can tolerate multiple anesthetic episodes for CT scan and radiation therapy
    • Informed client consent
  • Exclusion Criteria: Dogs with any of the following criteria would not be eligible for our study
    • Metastatic cancer
    • Tumor invasion of the facial skin surface
    • Female lactating or pregnant
    • Male or female dog used for breeding purposes
    • Serious systemic disorder incompatible with study or treatment
    • Prior history of MT0321 or radiation therapy
    • Corticosteroid or NSAID within 7 days of first radiation therapy
    • Dog determined to be inappropriate candidate by investigators
  • Treatment: All dogs will receive radiation therapy for treatment of the nasal tumor as clinically indicated. Radiation therapy will be conducted daily for 5 days (4 Gy per treatment daily Monday – Friday) and is performed under a light anesthesia – this is considered the standard of care. In addition, the study treatment called SQAP will be administered as an intravenous infusion over 5 minutes 15-30 minutes prior to each radiation treatment. This may be administered prior to or after induction of anesthesia.
  • Cost: The study will cover the cost of the SQAP, administration of SQAP, and a small amount (~ $300) towards the cost of radiation therapy. The costs of all other procedures are NOT covered by the research study. Clients will be responsible for all clinic costs. An estimate of costs for which you will be responsible will be prepared for you at the time of admission.
  • Contact: Contact the Clinical Studies Team at VM-ClinicalStudies@ufl.edu, or complete the Study Interest Form to see if your dog qualifies.
  • Principal Investigator: Dr. Sandra Bechtel, DVM, DACVIM (Oncology) and Dr. Keijiro Shiomitsu, DACVR (Radiation Oncology)

 

Background:

Sulfoquinovosylacylpropanediol (SQAP) is a novel potent radiosensitizer that makes tumor cells more sensitive to radiation therapy. Safety studies have shown that sulfoquinovosylacylpropanediol (SQAP) is well tolerated in both dogs and cats when used alone and in combination with radiation therapy.  The purpose of this research is to better understand how the agent sulfoquinovosylacylpropanediol (SQAP) may help make radiation therapy more effective in the treatment of nasal cancer in dogs.

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