WOOF for the Cure – Canine Lymphoma Study
Canine B-cell Lymphoma
WOOF for the Cure – Lymphoma Study
Purpose of the Study:
Presage Biosciences is sponsoring the study of a clinical diagnostic device called CIVO™ designed to enable the individual evaluation and prioritization of multiple anti-cancer agents in canine B-cell lymphoma without exposing the patient to systemic toxicity. During a brief outpatient procedure under sedation, the CIVO device is used to inject micro-doses of different anti-cancer drugs or combinations of drugs through the skin and directly into the canine patient’s lymph node. The node is then resected by a board-certified veterinary surgeon, and transferred to Presage scientists who evaluate each compound’s anti-cancer activity. By developing the clinical capabilities of this technology, Presage hopes to revolutionize personalized medicine and eliminate patient exposure to ineffective therapies.
Primary Eligibility Criteria:
• Diagnosis of B-cell lymphoma
• Peripheral lymphadenopathy
• >2.5 cm palpable and accessible node for injection through overlying skin
• No evidence of hypercalcemia
• Patient is clinically stable enough to delay treatment until after lymph node removal
• No contraindications to surgery or anesthesia
• Prior prednisone or chemotherapy is not exclusionary
• Non-randomized study
• A lymph node will be selected for CIVO microinjection and evaluated by ultrasound.
• Microdoses of several drugs or drug combinations will be administered directly into the lymph node during a brief outpatient procedure under sedation.
• 24 hours later, the injected lymph node will be removed by a board-certified veterinary surgeon and the tissue will be analyzed by Presage scientists to determine the anti-cancer activity of each injected compound.
The following services are covered by the study when performed by the participating veterinary clinic:
• Cytological confirmation of lymphoma, unless recently performed
• Blood and urine testing, unless recently performed
• Thoracic radiographs, unless recently performed
• Abdominal ultrasound, unless recently performed
• Costs associated with the injection procedure
• Complete cost for surgical removal of a lymph node
• Up to $1000 towards approved chemotherapy protocols
• Follow appointment schedule required by study protocol
• Cover all costs associated with treatment other than those funded by the study