Purpose and Brief Explanation of Study:
The primary objective of this study is to evaluate the activity of an investigational drug given to dogs with cancer that have not yet been treated or have failed chemotherapy. This investigational drug inhibits a very important pathway that has been shown to induce cell death in cancer cells and holds promise for treating lymphoma and other cancers.
What qualifies my dog for enrollment in this in this trial?
- A diagnosis of cancer
- Minimum weight of 20 kg (44 lb)
- Prior chemotherapy or radiation must be completed 2 weeks prior to study entry
- Dogs must have gross/measurable disease (approximately 2 cm)
- Dogs must be free of other diseases (heart, liver, and kidney) and otherwise feeling well (playing, good appetite).
- Your dog will be screened for eligibility based on bloodwork (complete blood count, biochemistry profile, urinalysis,+/- chest x-rays,+/- abdominal ultrasound)
What does enrolling my dog in this clinical trial involve?
Your dog will receive the investigational drug intravenously (IV) two times given 48 hours apart while hospitalized in the Veterinary Medical Center (VMC). Your dog will be discharged later that day after the second treatment and then will return to the VMC one week after the first treatment for re-evaluation.
Analysis for tumor response will be performed by direct tumor measurement or through the use of imaging (radiographs, ultrasound, CT). Standard bloodwork will be performed periodically throughout the study. Additional tests to be performed include blood draws, collection of peripheral blood cells (PBCs), fine needle aspirates (FNAs) and biopsies of the lymph nodes to determine how the investigational drug is affecting the cancer cells.
During the two drug treatments your dog will stay in the hospital overnight so that blood samples can be drawn to assess how the investigational drug blood levels change during the course of the day. The total volume of blood involved in this collection is approximately 6 tablespoons.
Following your dog’s completion of the clinical trial, you will receive a credit of $2000 for continued treatment of your dog at the VMC.
The clinical trial will cover the costs associated with trial screening for dogs that are eligible for the trial and enroll in the study. Screening costs will not be paid for ineligible dogs. For eligible, enrolled dogs, the clinical trial will cover all costs associated with screening prior to study entry, all treatments, and treatment of any side effects associated with the treatment.