OWNER CONSENT FORM
The Ohio State University
Veterinary Teaching Hospital
Name of Study: Hypofractionated Radiation Therapy Plus Palladia for Unresectable Canine Mast Cell Tumors
Name of Investigators: Cheryl London, DVM PhD; William Kisseberth, DVM PhD
Purpose and Brief Explanation of Study:
Mast cell tumor is a common skin tumor of dogs. Current treatment options available for mast cell tumor include various combinations of surgery, chemotherapy drugs such as vinblastine or lomustine, radiation therapy, and the new oral mast cell tumor drug PalladiaÒ (toceranib). Palladium is an oral drug which works by inhibiting the function of a protein important for mast cell survival called KIT. Large studies have demonstrated that Palladia can be effective for some canine mast cell tumors. However, most mast cell tumors treated with Palladia do not go away completely, and improvement with Palladia is not permanent. Through this clinical trial, we are seeking to determine whether the addition of radiation therapy to Palladia will result in a higher likelihood of tumor shrinkage, and/or a longer duration of improvement.
Which patients are eligible to participate in this clinical trial?
Dogs with confirmed mast cell tumor, with or without lymph node involvement, are eligible for this study. Dogs must undergo some diagnostic testing prior to starting the study to ensure that they are eligible. They must have good function of liver and kidneys, have acceptable blood cell counts, and are free of severe underlying disease. Prior surgery or medical treatment for mast cell tumor is acceptable, with a 2-week washout from prior chemotherapy or surgery.
What will happen if my dog participates in this clinical trial?
Initially your dog will undergo a series of diagnostic tests, which may include blood tests, urinalysis, a fine needle aspirate of the lymph node draining the tumor area, and ultrasound examination of the abdomen. The results of these initial staging tests will determine if your dog is eligible to enter this clinical trial. These tests are part of the routine testing done in mast cell tumor patients, and may be performed even if you decide that your dog will not participate. Blood will be collected for study-related testing. Your dog will be sent home with medications to prevent side effects (Benadryl, pepcid/omeprazole, and prednisone), and Palladia, which will be started 3 days later. One week following the start of Palladia, your dog will return for a series of 3 or 4 weekly radiation treatments. Regular rechecks will be performed after the completion of radiation therapy.
What side effects or risks may my dog experience while participating in this clinical trial?
Your dog may experience side effects. Side effects may be mild or serious, including the risk of death. The most common side effects seen with Palladia are loss of appetite and diarrhea. Nausea/vomiting and lowering of the white blood cell count can also be seen. The type of radiation therapy being used for this study rarely causes side effects, however some changes to the skin in the area where radiation is delivered are possible. Everyone involved in your dog’s care will monitor carefully for side effects and medications may be prescribed to help lessen side effects.
How long will my dog be in the clinical trial?
The length of the clinical trial is determined by response to treatment. For those dogs whose tumors shrink or do not grow, treatment may be continued indefinitely as long as the medication is tolerated. Every-6-week rechecks will be instituted following the completion of radiation therapy.
Can my dog withdraw from the clinical trial?
You may decide to withdraw your dog from the clinical trial at any time. It is important to discuss withdrawal in order to determine a plan for continued treatment of your dog’s cancer. Additionally, your dog may be removed from the study at any time if we believe it is in your dog’s best interest or if the trial is discontinued or if the trial protocol is not followed.
What financial incentives will be provided for my dog’s participation?
Clients participating in this study will be given special financial considerations. The study will pay for Palladia and a portion of the radiation therapy and blood monitoring for 16 weeks following the start of treatment (up to $1500); the client costs for the entire 16 week treatment period are expected to be approximately $950, including the 4 treatments of radiation and all visits. Following this period of time, blood tests to insure that Palladia is being tolerated will become the responsibility of the owner. The owner will be responsible for the initial tests to insure eligibility to participate, the cost of recheck examinations, and the cost of ancillary medications (Benadryl, omeprazole, prednisone).
What are my responsibilities during the clinical trial?
You are responsible for the cost of diagnosing and staging your dog’s mast cell tumor prior to entering the study (approximately $600.00-800.00). You are expected to make and keep all appointments according to the study protocol. You must be committed to completing the entire study protocol and follow-up examinations.
I understand that the veterinarians at this institution are engaged in research into the nature and treatment of malignant diseases. The detailed procedures of the Canine Palladia plus Radiation Therapy Clinical Trial have been explained to me by: Dr. __________________on____________.
As part of this particular study, I understand the following:
1. My dog must have measurable mast cell tumor to be eligible for this clinical trial. My dog may be untreated or previously treated with surgery or chemotherapy. If my dog has had previous treatment, I understand that a withdrawal period of 3 weeks for chemotherapy is required prior to my dog enrolling in the study.
2. My dog will be treated by a group of veterinarians specializing in clinical cancer research.
3. The purpose of this study is to evaluate the safety and efficacy of Palladia and radiation therapy in dogs with mast cell tumors.
4. Both Palladia and this form of radiation therapy have been studied extensively in normal dogs and dogs with cancer, but the combination has not been studied before. This treatment is being offered to my dog to continue an ongoing effort to evaluate the merits of this therapy. I realize that it is possible my dog will not benefit from the use of this treatment.
5. All drugs and methods used have been carefully tested individually to minimize potential toxicity. However, I realize it is possible my dog will experience unexpected side-effects which could be mild or severe (including death). My dog will be observed closely for side effects.
6. Alternate (non-study) treatment protocols have been discussed and I understand the relative benefits of those treatments.
7. My dog will receive the drug, Palladia (toceranib phosphate), by mouth three days per week while enrolled in the study. Radiation therapy will be delivered in 3 or 4 treatments over 4 weeks.
8. Blood specimens are an integral part of the treatment program and will be done at intervals at the recommendation of the veterinarian-in-charge. I understand and agree that any tissue and fluid samples collected from my dog will become the property of Ohio State University.
9. Clients participating in this clinical trial will be given special financial considerations. Specifically, the study will partially cover the cost of blood work and radiation therapy (up to $1500) and Palladia will be provided at no expense. It is anticipated that my costs for treatment of my dog in this clinical trial will approximate $950 and I will be responsible for the purchase of any ancillary medications (i.e., Benadryl, Pepcid, etc). If a positive response is observed, Palladia will be provided indefinitely at no cost but the costs associated with recheck examinations, blood tests and pharmacy fees become my responsibility after 16 weeks. Costs associated with the treatment of adverse effects may be defrayed up to $2,000.
10. I give my permission to publish data obtained from this clinical trial for the benefit of the scientific community. I understand that my dog will not be identified individually.
11. I may withdraw my dog from this study at any time, without penalty.
12. The veterinarian-in-charge may withdraw my dog from this study if he/she determines that my dog is affected adversely.
13. If my dog dies while on study, a postmortem examination at this institution will be requested to explain the cause of death.
As a result of discussion with Dr. ________________________, and after reading the above, I voluntarily consent to assignment of my dog to the clinical trial treatment program. I consent to participate in this project and will follow the instructions of the veterinarians-in-charge, as it pertains to therapy and follow-up procedures.
Signed ___________________________________________ Date ____________________
Owner or authorized agent of the owner
Witnessed By: _____________________________________ Date ____________________