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By Katonah Bedford Veterinary Center
Published: May 28, 2014

Dear Veterinary Colleagues,

Katonah Bedford Veterinary Center has been approved for a fully funded clinical study for cats with oral squamous cell carcinoma. Inclusion criteria follows. Please contact us if you have potential candidate patients or if you would like further information or have questions regarding the study. Thank you.

Virginia Gill DVM, DACVIM (Oncology)
Philip Bergman DVM, PhD, DACVIM (Oncology)

MAY 2014

Squamous cell carcinoma (SCC) is the most common oral tumor in cats (~70%). Most cats with SCC are around 10 years of age. The tumor is often noted on a physical examination or during a routine dental cleaning, however, most patients present with clinical signs related to the tumor. Clinical signs include, weight loss, abnormal chewing, bad breath, drooling and often the presence of swelling along the oral cavity. These tumors can be very aggressive and often will destroy and invade a great deal of the underlying bone. The tumor can occur either under the tongue, upper or lower jaw. Often there is a secondary infection from dead tissue surrounding the tumor.

Surgery alone is often not possible due to the tumor location. Cats also tend to experience high morbidity post oral surgery. There is little evidence to suggest chemotherapy alone also is effective against this disease and generally, radiation therapy is palliative in nature designed to minimize pain with little impact on tumor size or survival.

Clearly, no effective therapy for SCC exists at this time and novel therapies are needed. Katonah-Bedford Veterinary Center, working with MBF Therapeutics Inc, is enrolling cats with oral squamous cell carcinoma for a clinical trial to evaluate the safety and effectiveness of a new Polyamine-Based Therapy (PaBT™), a combination of two novel anticancer agents (2-diflouromethylornithine (DFMO), an ornithine decarboxylase (ODC) inhibitor, and MBF 1569, a polyamine transport inhibitor (PTI)). This is a targeted therapy, in that each agent attacks a different aspect of the cellular metabolism of the cancer. A large body of literature indicates that tumor cells require an efficient polyamine metabolic pathway for optimal growth; thus restricting its availability via this two drug combination should beneficially impact tumor growth. Preclinical studies suggest that this treatment may also stimulate an immune response to enhance the body’s ability to fight the tumor.

Previously this combination has been evaluated in cats and deemed safe and effective. The goal of this trial is to further evaluate the safety and determine an optimal dose of this combination. This study is funded to cover costs of the examinations, bloodwork and the agent is provided at no cost. Patients responding will be able to continue on compassionate usage for 6 months.

Inclusion Criteria

Cats must be deemed to be in otherwise acceptable systemic health based on results of physical examination, complete blood count, serum chemistry screen, and urinalysis. Patients deemed in poor body condition as a result of the primary tumor will not be eligible for enrollment.

  • Oral SCC that is in a location in which repeat measurements are feasible.
  • Cats should have a life expectancy of at least one month.
  • Cats that have failed conventional therapies are eligible with a 2 week washout period. This includes non-steroidal and steroid medications.
  • Other pain medications may be prescribed as needed, including tramadol at 2-4 mg/kg q8-12h or Buprenorphine 0.01mg/kg sublingual BID.
  • A consent form must be signed by the pet owner.

Exclusion Criteria

  • Patients may be excluded from the study if tests indicate spread to regional or distant sites.
  • Patients may also be excluded from the study if the severity of the tumor is already significantly affecting quality of life.
  • Cats with pruritus due to skin disease are excluded from the study.
  • Cats with chronic renal, hepatic or cardiac failure are excluded from the study.

For more information please contact our oncology service.
Phone (914) 241-7700
Fax (914) 241-7708

Virginia Gill DVM, DACVIM (Oncology)
Philip Bergman DVM, PhD, DACVIM (Oncology)
[email protected]