Purpose of Study
The purpose of this clinical trial is to evaluate the safety and effectiveness of rapamycin when given to dogs with cancer. Rapamycin is a drug currently approved for immunosuppression during preparatory and maintenance regimens for organ and bone marrow transplant in human patients. Early work with rapamycin suggests that this agent may also have anti-cancer properties by inhibiting an important pathway in cancer progression known as mTOR. Preclinical studies of rapamycin in mice, as well as recent data using analogous drugs in human patients suggest that mTOR blockade may be effective in the treatment of several cancers. This trial is led by the National Cancer Institute (NCI) and sponsored by the Morris Animal Foundation.
Costs associated with this study will be covered for enrolled dogs and owners will receive a $500 credit to their dog’s account upon completion of the study. In the event any complications arise during the study period, their management will be covered by study funds up to $2,000 per dog per event.
Enrolled dogs must have a diagnosis of osteosarcoma or soft tissue sarcoma. Their disease must be measurable by physical exam, radiographs and/or abdominal ultrasound so that their response to the treatment can be evaluated. In order to be eligible, dogs must be otherwise healthy, have sufficient organ function (determined by recent blood work) and weigh 33 pounds or more. Dogs who are already being treated with chemotherapy or radiation must wait for two weeks after their last treatment before starting this study. While on this study, dogs cannot take NSAIDs. If they are already taking NSAIDS, they must have a 72 hour washout period before study entry.
Within this study, we ask that you permit and administer oral rapamycin at home for 26 days. The schedule for drug administration will either be 5 days on and 2 days off (Mon-Fri with no drug administered on Sat or Sun) or Monday, Wednesday, Friday. You will be responsible for giving oral rapamycin in a timely fashion to your dog at home. This will require 4 hours of pre-dose and 1 hour of post-dose fasting. You will be provided with a recording sheet and will be required to log the date, time, and amount of drug dosed each time your dog receives rapamycin. In addition, you will be asked to fill out an owner assessment form each time your dog returns to WSU for rechecks.
Once it is determined that your dog qualifies for the study, we will ask you a series of questions that will help us put together a detailed health history for your dog. You will schedule an appointment for the following Monday. This will be study Day 1 for your dog. On day 1, your dog will receive a physical exam, blood will be collected, and then your dog will receive their first dose of rapamycin. We will collect small amounts of blood on a set schedule throughout the day so we can measure how much rapamycin is in your dog’s blood. In addition, we will collect a small amount of blood on day 2 and day 3. Your dog will spend two nights at WSU’s VTH before being sent home on day 3. Your dog will need to return one week (day 8), and two weeks (day 19) later for recheck examinations and blood tests. On day 26 (end of the study), your dog will again need to spend 48 hours at the VTH for scheduled blood collection and a physical exam.
Owners are responsible for the costs associated with their dog’s cancer diagnosis. If their dog was not diagnosed or treated at WSU and will be visiting with the sole intent of entering this study, owners will be responsible for the costs of the initial consultation with an oncologist and any lab work or other diagnostic tests required to determine eligibility. Once enrolled, owners will be responsible for bringing their dog to WSU’s Veterinary Teaching Hospital on days 1, 8, 19, and 26. They will need to be willing to allow their dog to stay overnight at the VTH on days 1 and 2, and again on days 26 and 27. Finally, owners will be responsible for giving rapamycin pills to their dog on a set schedule at home.
**NOTE: Precautions should be taken against human ingestion or direct contact with rapamycin, especially in immunosuppressed individuals. If you think you have increased risks of immune suppression, you should contact your physician before enrolling your dog in this clinical trial. Women who are pregnant or potentially pregnant should not handle rapamycin.
For more information please contact:
Valorie Wiss, Clinical Studies Coordinator