Spleen hemangiosarcoma clinical trials for dogs.

ILLINOIS
Study: Efficacy and safety of masitinib alone or in combination with doxorubicin for the treatment of
dogs with splenic hemangiosarcoma
Location: University of Illinois
Phone: Clinical Trials Coordinator Nancy George (217)-244-7789 or Dr. Jackie Wypij (217) 265-6704. Referring
veterinarian and/or client calls are welcome.
www.vetmed.illinois.edu/vth/documents/clinical_trials/HSA_trial_flyer.pdf

Eligibility: The inclusion criteria for the study are as follows:
1) Dogs with confirmed splenic HSA (post-splenectomy)
2) Dogs must have a favorable performance status
3) NO significant organ dysfunction or concurrent disease(s) that would limit survival
4) NO history of kidney disease or proteinuria
5) NO prior treatment with high-dose corticosteroids, immunosuppressive agents, chemotherapy, or radiation therapy
6) NO vaccination within last four weeks
7) Signed informed owner consent; all treatment options for the pet will be presented and owner must decline all other
options
8) Metastasis is acceptable

Therapy: Masitinib is a novel oral chemotherapeutic drug (tyrosine kinase inhibitor) that is approved in Europe to treat
canine mast cell tumors and also demonstrates in vitro activity against other cancers. The purpose of this prospective,
multicenter, phase 2 study is to investigate the safety and anti-cancer activity of masitinib in canine hemangiosarcoma
(HSA). In this study, dogs with splenic hemangiosarcoma (post-splenectomy) will be randomly assigned to one of three
treatment groups. Group 1: oral masitinib (single agent), Group 2: oral masitinib and doxorubicin combination, Group 3:
doxorubicin (single agent). Treatment groups will be compared using biologic parameters, survival time, progression-free
interval, and quality of life in dogs with splenic hemangiosarcoma to assess safety and efficacy. Diagnostics will include: 1)
Bloodwork and urinalysis 2) Three view thoracic radiographs 3) Abdominal ultrasound.

Incentives: The study will partially cover treatment costs associated with the study. Dogs on the masitinib arms will receive
free masitinib for the duration of the study. Dogs on the doxorubicin arms will receive $100 toward each doxorubicin
treatment, up to five doses. All other treatment costs, office fees, and all initial and follow up diagnostic charges will be the
responsibility of pet owners.

MASSACHUSETTS
Study: Metronomic Chemotherapy in Dogs with Splenic Hemangiosarcoma
Location: Tufts University Cummings School of Veterinary Medicine, North Grafton, MA
Phone: Kelly Reed, Oncology Liaison; (508) 887-4682
http://cgi.vet.tufts.edu/clinical_trials/projects/metronomic_chemotherapy_in_dogs_with_splenic_hemangiosarcoma

Eligibility: Dogs with hemangiosarcoma that have completed a standard course of chemotherapy after removal of the
affected spleen. Dogs with a life expectancy of less than 1 month or who have lower urinary tract disease are ineligible.

Summary: The goal of this study is to evaluate the efficacy of low dose of metronomic chemotherapy as a maintenance
therapy in dogs with hemangiosarcoma. Hemangiosarcoma is a common tumor developing in the spleen of dogs. Despite
aggressive treatment with surgery and chemotherapy, most dogs die of metastatic disease shortly after treatment
Metronomic (low dose chemotherapy) entails very small doses of chemotherapy that are given daily or every other day
and help deter the growth of new blood vessels needed to nourish cancer as it grows. Side effects associated with
metronomic chemotherapy tend to be milder and less frequent than those seen with standard chemotherapy. This form of
chemotherapy has been used in dogs with spenic hemangiosarcoma after surgery and has been found to have efficacy
as a single agent.

Requirement and incentive: This study is not funded; so pet owners are responsible for all costs associated with this
treatment.

NEW JERSEY
Study: Genomic profiling of dogs with mast cell tumors (MCT) and splenic hemangiosarcoma (HSA)
Location: Red Bank Veterinary Hospital
Phone: Clinical Trials Office at (732) 747-3636, ext. 1509
www.rbvh.net/trialdetails.php?Mast-Cell-Tumors-9

Eligibility:

Owner consent to allow collection of clinical specimens and to comply with follow-up treatment requirements.
General clinical evaluation: medical history (include age, breed, gender), physical exam
Any gender is eligible
Dogs will be >1 year or age
All stages are acceptable.
Complete staging evaluation with thoracic and abdominal radiographs (or ultrasound), BM aspiration cytology at
each site.
Histological diagnosis (no grade, just stage).
A maximum of 30% cases can be relapsed patients (level monitored by ACI).
Immunophenotyping to be performed at each site.
Owner consent to allow collection of clinical specimens and to comply with follow-up and treatment requirements.
General clinical evaluation: medical history (include age, breed, gender), physical exam, complete blood count,
biochemical profile, and urinalysis.
Naïve (i.e. de novo) and relapsed cases including those that have received and/or failed prior chemotherapy (with
chemotherapy history).

Summary: This trial is only for cases already undergoing surgical excision of tumors. Upon surgical excision at Red Bank
Veterinary Hospital, a portion of the tumor will be stored for analysis.

The goal of this trial is to provide tumor tissue for research purposes. Eligible tumor types include:
•Mast cell tumor
•Osteosarcoma
•Hemangiosarcoma

Financial Incentives: Owners will receive a $500 credit toward costs of the surgery and a $250 credit toward the costs of
other misc. items (diagnostics, medication etc.) at Red Bank Veterinary Hospital.