Study Title: The Effect of an Investigative Agent on Progression of Residual Disease in Canine Hemangiosarcoma
Current Status: Open and enrolling
Principle Investigators: Dara L. Kraitchman, V.M.D., Ph.D., F.A.C.C., email@example.com; Rebecca A. Krimins, D.V.M., M.S., firstname.lastname@example.org
This clinical trial is currently closed to new enrollment.
Contact us for more information about this clinical trial.
This is a clinical trial that will enroll a total of nine dogs in order to evaluate the effects of an FDA-approved investigative agent on dogs that have hemangiosarcoma (visceral and/or cutaneous). Safety and toxicology studies have been performed in healthy dogs. This is the first trial using the agent for treating canine hemangiosarcoma.
Selection of Participants
Eligible dogs will have undergone histopathologic evaluation of their tumor at their local veterinary hospital. Following visceral or cutaneous diagnosis of hemangiosarcoma, the patient may be considered for enrollment. Dogs should weigh more than 10 kg (22 lbs) to be eligible for participation and be older than 1 year of age. Preoperative medical records, radiographs, ultrasounds, complete blood counts, serum chemistries and urinalyses will help us determine if dogs are eligible for this trial. In addition, each pet owner must sign an informed consent form in order to participate in the clinical trial.
Participating dogs should meet the following criteria:
- The owner is willing to comply with all study procedures and be available for the duration of the study
- The patient should have no concurrent kidney, liver or heart disease, or problems with blood clotting
- The patient should have no heart-based tumors
- Splenectomy or lobectomy or histopathologic confirmation - the surgery is not part of the study; the surgery and diagnostic fees are paid by the owner
- After confirmation of hemangiosarcoma, the study will provide a PET-CT scan (whole body) to determine the dog's baseline tumor burden as well as a blood test to check for a mutation in the MDR1 gene
- Dogs with metastatic tumors measured by PET-CT scan are eligible for enrollment
- Chemotherapy: the first chemotherapy will be given within one week of the initial PET-CT scan. A second chemotherapy session will be given one week later. During week three, there will be no treatment. This cycle will be repeated two more times for a total of six chemotherapy sessions. Prior to every chemotherapy session, blood tests will be performed
- Follow-up PET-CT scan will be performed after chemotherapy has finished
- Once a month physical examination will be performed (this may include blood tests, radiographs and/or ultrasound) for 2-3 more visits after chemotherapy has concluded
Cost of Studies
Owners are responsible for their dog's initial surgery (workup). The study pays for all diagnostics and therapies that occur at the Center for Image-Guided Animal Therapy including the MDR1 genetic test, PET-CT scans, chemotherapy, lab work, and physical examinations.