Study: Palladia vs. vinblastine in canine mast cell tumors.

Available at the following locations:
COLORADO
: Colorado State University Animal Cancer Center, Fort Collins, CO (970-297-419)
OHIO: Ohio State University Veterinary Medical Center, Columbus, OH (clinicaltrials@cvm.osu.edu)
WISCONSIN: University of Wisconsin Veterinary Teaching Hospital, Madison, WI (608-263-7600)

Eligibility: Dogs with confirmed mast cell tumor, with or without lymph node involvement, are eligible for this study. Dogs
must undergo some diagnostic testing prior to starting the study to ensure that they are eligible, including bloodwork
(complete blood count and chemistry profile), regional lymph node aspirate, thoracic radiographs, and abdominal
ultrasound. They must have good function of liver and kidneys, have acceptable blood cell counts, and are free of severe
underlying disease. Prior surgery for mast cell tumor is acceptable, but no previous chemotherapy is permitted.

Summary: Mast cell tumor is a common skin tumor of dogs. Current treatment options available for mast cell tumor include
various combinations of surgery, chemotherapy drugs such as vinblastine or lomustine, radiation therapy, and the new oral
mast cell tumor drug Palladia® (toceranib, Pfizer). Vinblastine is an intravenous chemotherapy agent that is commonly
used in the treatment of mast cell tumors. Palladia is an oral drug that works by inhibiting the function of a protein important
for mast cell survival called KIT. Activating mutations in KIT are found in a population of mast cell tumors, and Palladia has
been shown to be more effective against tumors with this mutation. The clinical trial will investigate the difference in
responses of mast cell tumors with and without a mutation in KIT to Palladia and vinblastine.

Requirements: The owner is responsible for the cost of diagnosing and staging the mast cell tumor prior to entering the
study (approximately $600.00-800.00). Owners are expected to make and keep all appointments according to the study
protocol. In addition, they must be comfortable administering oral medications at home, and must be committed to
completing the entire study protocol and follow-up examinations.

Financial Incentives: Clients participating in this study will be given special financial considerations. The study will pay for
the initial biopsy, KIT genotyping (to determine mutation status), chemistry profiles, and costs associated with treatment
(Palladia or vinblastine). The owner will be responsible for the costs of the initial examination and tests to insure eligibility to
participate, the recheck examinations, complete blood counts, and ancillary medications (Benadryl, omeprazole,
prednisone).


Study: Palladia plus Lomustine for the Treatment of Unresectable Canine Mast Cell Tumors

Available at the following locations:
ARIZONA:
Southern Arizona Veterinary Specialty & Emergency Center, Tuscon, AZ (1-877-762-9838; 520-888-3177)
NORTH CAROLINA: North Carolina State University Small Animal Clinic, Raleigh, NC (919-513-6690 )

Eligibility:
  • Dogs with measurable cutaneous or subcutaneous mast cell tumors confirmed by histopathology or cytology.
  • Any stage or grade is allowed.
  • Patient is expected to survive at least 6 weeks.
  • Patients must be free of other severe diseases.
  • Dogs must undergo some diagnostic testing prior to starting the study to ensure that they are eligible.
  • They must have good function of liver and kidneys and have acceptable blood cell counts.
  • Prior surgery or chemotherapy will be allowable with a 14 day washout.
  • Dogs having received prior toceranib or Lomustine will NOT be eligible.

Summary: Mast cell tumor is a common skin tumor of dogs. Current treatment options available for mast cell tumor include
various combinations of surgery, chemotherapy drugs such as Vinblastine or Lomustine, radiation therapy, and the new
oral mast cell tumor drug Palladia® (toceranib).

CCNU (also known as Lomustine) is an oral chemotherapy drug that has been used in the treatment of mast cell tumors in
dogs. Palladia® is an oral drug that works by inhibiting the function of a protein important for mast cell survival called KIT.
Activating mutations in KIT are found in a population of mast cell tumors, and Palladia® has been shown to be more
effective against tumors with this mutation. The purpose of this study is to determine if using Palladia® in combination with
CCNU will have better anti-tumor effect for dogs with mast cell tumors than CCNU used as a sole treatment.

Owner's responsibiltiies:
  • Responsible for the cost of diagnosing and staging the mast cell tumor prior to entering the study.
  • Expected to make and keep all appointments according to the study protocol.
  • Must be comfortable administering oral medications at home.
  • Must be committed to completing the entire study protocol and follow-up examinations.

Financial Incentives: Clients participating in this study will be given special financial considerations. Clients will be
responsible for the costs of the consult (initial) examination and tests to insure eligibility to participate. Once enrolled, all
costs related to the study will be covered except for the recheck exam fee.


OHIO
Study: Evaluation of four STA-1474 dosing regimens in dogs with mast cell tumors
Location: Ohio State University Veterinary Medical Center, Columbus, OH
Contact:    clinicaltrials@cvm.osu.edu
http://vet.osu.edu/vmc/evaluation-four-sta-1474-dosing-regimens-dogs-mast-cell-tumors

Eligibility: To qualify for enrollment in this study, dogs must have:

  • a cytologic or histologic diagnosis of MCT.
  • be at least 1 year of age.
  • adequate organ function
  • not have evident of systemic disease
  • an estimated life expectancy of at least 8 weeks.
  • not received prior chemotherapy (including Kit inhibitors) or radiation therapy although can have received
    prednisone

Background: Heat shock protein 90 (HSP90) is a chaperone protein important in the maintenance of several cellular
proteins such as the oncogene Kit. Evidence suggests that its activity is upregulated in cancer cells to maintain appropriate
folding and expression of client proteins, particularly when these proteins are over-expressed or mutated.  As such,
adequate HSP90 activity is considered to be critical for the survival of several types of cancer cells.  STA-1474, a novel
water-soluble resorcinol-containing compound, is metabolized to STA-9090, a potent HSP90 inhibitor that exhibits superior
anti-tumor efficacy relative to HSP90 inhibitors of the geldanamycin class.   A Phase 1 trial of STA-1474 was performed in
25 dogs with spontaneous tumors. Measurable responses were observed in dogs with mast cell tumors, osteosarcoma,
melanoma and thyroid carcinoma. The greatest biologic activity occured in a dosing cohort that received STA-1474 at 9.5
mg/kg over 8 hours resulting in plasma levels of STA-9090 greater than 50 ng/ml for 12 hours suggesting that long plasma
exposures may be associated with greater biologic activity.  Given that an 8 hour infusion of STA-9090 in the human
clinical setting is not possible, this study seeks to determine whether two consecutive days of treatment with STA-1474 is
superior to other regimens with respect to target modulation and response to therapy.  

Study design: Dogs with MCT will undergo screening including complete blood count, chemistry panel, urinalysis and
abdominal ultrasound to determine eligibility for the study.  A baseline tumor biopsy will then be obtained if your dog is
found to be eligible.  Your dog will receive standard medications prior to getting STA-1474 to prevent any diarrhea or
vomiting.  

Following the biopsy, your dog will receive STA-1474 on one of four schedules:  
  • a single dose of STA-1474 at 6 mg/kg over 1 hour
  • 6 mg/kg over 8 hours
  • 3 mg/kg over 1 hr for two consecutive days
  • 3 mg over 1 hour twice per week Friday/Monday).
  • A tumor biopsy will be obtained 24 hrs and 72 hours after the last STA-1474 administration on the first cycle.  The
    treatments will then be repeated for another 3 cycles, although no further biopsies will be performed. If your dog has
    responded to therapy, then you will have the option of continuing treatment with STA-1474, although the costs for
    drug administration will not be covered for these subsequent treatments.   

Incentives: All costs associated with this study are covered by the study including management of any side effects that may
occur.  
PET CANCER CENTER
Comprehensive guide to cancer diagnosis and treatment in cats and dogs
© 2007 Pet Cancer Center. ALL RIGHTS RESERVED.
Last updated 8/22/13
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