Nasal Tumors
Purpose of the Study
The goal of this study is to determine the activity of toceranib
phosphate (Palladia™
) alone or as a
radiation sensitizing agent in the treatment of canine nasal carcinoma.
These findings will be compared to historical controls treated with
radiation alone.
Nasal tumors are a common canine neoplasm and carcinomas are the most
common type of nasal tumor. Most nasal carcinomas are very
aggressive locally. Untreated patients survive an average of 3-5
months. Radiation therapy is currently the treatment of choice as
it extends median survival times to 8-25 months. Long term
control of this tumor is rarely achieved so new approaches to treatment
of this uniformly fatal tumor are needed.
All tumors must develop new blood vessels in order to grow.
Palladia is a tyrosine kinase inhibitor that inhibits the development of
new blood vessels by targeting receptors called vascular endothelial
growth factor receptors (VEGFRs). These receptors have been
documented to occur in canine nasal tumors and early reports indicate
that Palladia has primary activity in these tumors. Palladia has
also been shown to sensitize tumor tissues to the effects of radiation
therapy. Because of these findings, clinical investigation of
Palladia as therapy for nasal carcinomas, alone or in combination with
radiation therapy is needed to know if we can increase our efficacy in
controlling these tumors in comparison to radiation therapy alone.
We also need to make certain it is safe.
To test this we are performing an open label multi-center clinical trial
giving dogs with nasal carcinoma Palladia, with or without radiation
treatment. Whether or not to include radiation therapy in your
pet's treatment plan is your decision. We expect that treatment
with Palladia will benefit dogs with nasal carcinoma by increasing
response rates and prolonging disease free intervals and overall
survival times. The results, if positive, will provide a novel
avenue of treatment for this uniformly fatal cancer.
Patient Entry Criteria
Dogs with a diagnosis of nasal carcinoma, that are greater than 24 months of
age, greater than 6.8 pounds of body weight, have greater than a 6 week
estimated life expectancy, and have adequate organ function. They may not have
evidence of extension of tumor into the brain, lymph node or any other
metastasis, another known serious disorder incompatible with the study, or be
pregnant or lactating.
Financial Incentives
Free drug and this drug has a value of $300 -$500 per month, free CT
exams for monitoring of tumor, free follow up exams and lab tests (value
$1500-$2000).
Owner Responsibilities
The entry criteria requires that your dog will need to have had
imaging done (CT or MR) and a biopsy of the disease process in the nasal
passages before we will know if they qualify for the study. Preliminary
work up can easily be done at the VTH but will be at your expense.
Full work up with thoracic radiographs, blood work ad urinalysis, nasal
imaging and biopsy would usually cost around $1500 at WSU.
If qualified and you chose to have radiation done with the addition
of Palladia you will be required to pay for radiation but the drug is
free. Radiation will involve 10 fractions of radiation given on a
Monday through Friday schedule for 2 consecutive weeks. Cost of
treatment would be around $1500 and if boarding is required that is
additional. If you decide to treat only with Palladia the drug is
free.
Once beginning therapy owners must be prepared to return for regular
checkups and refilling of the Palladia prescription. A
physical examination, complete blood count, toxicity assessment, and
drug accountability will be performed weekly for the first two weeks,
then at week 4, then at four week intervals. The fees for these
procedures and tests will be covered by the study. A CT will also be
repeated periodically.
Contact Information
If interested please contact Betsy Wheeler or Pam Thompson at the WSU VTH
335-0711.
