Hi there,
Thank you for taking the time to complete our online pre-screening survey and for your interest in clinical trials here at OSU. I am very sorry to hear that your dog, Kookie, has been recently diagnosed with osteosarcoma. It looks like Kookie could potentially be a good candidate for your trial. In order to fully see if Kookie would be a good candidate we would need her to come in through our Oncology service to be screened. I have attached the trial’s consent form for you to review to gather more information on this clinical trial. If you would like to schedule for Kookie’s consultation with our Oncology service please call 614-292-3551. Once she is evaluated we will be able to see if she can be screened into our clinical trial.
I do want you to know that this initial visit will be your financial responsibility, however once Kookie is enrolled into the trial all tests and procedures will be covered by the trial. Unfortunately, I am not able to give an estimate of initial visit costs. If she does enroll we will need to see Kookie once weekly for 14 weeks and then we will see her back every 8 weeks. After reviewing the consent form please let me know if you have any questions, I’m happy to help!
Kind regards,
Ali
............... consent form
Study Title: Optimization and validation of a universal donor allogeneic TGFβ-1-resistant NK (AT-NK) cell product in canine spontaneous osteosarcoma
Principal Investigators: William C. Kisseberth, DVM, PhD Telephone: 614-247-7201 Dean A. Lee, MD, PhD
This form is designed to provide you with information about this study, so you may make an informed decision about your animal’s participation in the project. This study has been approved by The Ohio State University (OSU) Institutional Animal Care and Use Committee (IACUC).
Please read the following items.
1. What is the purpose of this study? The purpose of this study is to establish the safety, biological activity, and preliminary evidence of efficacy of adoptively transferred (transfused) ex vivo expanded (grown in the laboratory) natural killer (NK) cells from healthy dogs given in combination with chemotherapy to dogs with osteosarcoma.
2. What procedures/treatments will my dog experience if enrolled in this study? Your dog will first be screened for eligibility to enroll in the clinical trial. Screening procedures include blood and urine sampling (free catch, or via cystocentesis), thoracic radiographs, and fine needle aspirate cytology. Patients meeting eligibility criteria will be administered labeled (19F) or unlabeled AT-NK cells prior to standard of care limb amputation. Following limb amputation your dog will receive up to 3 infusions of AT-NK cells over 48 hours. At the time of suture removal (10-14 days later) your dog will receive standard of care carboplatin chemotherapy every 3 weeks for 4 treatments. On the weeks your dog does not receive chemotherapy, your dog will receive an AT-NK cell infusion (total of an additional 8 infusions). At each appointment visit, blood samples will be obtained for monitoring NK cell numbers and activity, as well as other correlative assays. Throughout treatment and after completion of the treatment protocol your dog will be monitored for lung metastasis by thoracic radiography (every 8 weeks).
3. What are the potential benefits to my dog for participating in this study? The goal of this study is to develop NK cell immunotherapy for the treatment of dogs and people with cancer and other diseases. Standard of care adjuvant carboplatin chemotherapy alone delays metastatic progression (cancer spread) compared to surgery alone. The potential benefits of adoptive NK cell therapy are unknown.
REV 3.0
09.25.2020
AT-NK Cell Phase I Clinical Trial for Canine Osteosarcoma
4. What are the possible risks to my dog? Risks associated with the standard of care portion of this clinical trial (limb amputation and carboplatin chemotherapy) include complications from routine blood and urine collection procedures (minor hemorrhage and bruising at needle puncture sites in peripheral veins and bladder, respectively; rarely urine leakage, i.e. uroabdomen associated with urinary bladder cystocentesis), anesthesia (cardiac and respiratory arrest and death), vomiting, diarrhea, low blood cell counts, and sepsis (blood infection). Risks associated with NK cell infusion includes transfusion reactions/anaphylaxis, including fever, vomiting, diarrhea, hives, pruritus, shock, vasovagal event, neurologic signs, including seizure and death. Anaphylaxis/infusion reactions were observed in the first two dogs (2 of 2 dogs) treated with this therapy. In the first dog treated, subsequent AT-NK cell infusions were given without the occurrence of further infusion reactions by pre-treating with diphenhydramine (Benadryl); however, such reactions remain a risk you need to be aware of.
5. What non-study options are available for my dog? Participation in this study is entirely voluntary. Alternatives to enrollment in this clinical trial for eligible patients include standard of care limb amputation and adjuvant chemotherapy, radiation therapy, and medical pain management.
6. What are the financial costs and/or benefits associated with enrolling my dog in this study? The clinical trial covers costs associated with all planned study related procedures prior to and after limb amputation. You are responsible for all costs associated with screening tests (CBC, serum chemistry, urinalysis, fine needle aspiration cytology, thoracic radiographs, and if needed abdominal ultrasound), limb amputation surgery and
immediate post- operative care. In the event of treatment related toxicities (side effects) requiring supportive medications, or hospitalization, up to $1000 will be provided to partially defray the cost of their treatment.
Please initial each statement
I realize that any tests, procedures, or treatments beyond those specifically listed above are my responsibility.
I have read the information above and understand the purpose and requirements of the clinical study entitled "Optimization and validation of a universal donor allogeneic TGFβ-1-resistant NK (AT-NK) cell product in canine spontaneous osteosarcoma”.
My dog has met the requirements to participate in this study.
Data, tissue and fluid samples collected from my dog will become the property of The Ohio State University.
I give my permission to publish data and images obtained from this study. I understand that all personal identifying information will be kept confidential.
If I choose not to participate in this study it will not affect the care of my dog.
I may withdraw my dog from this study without penalty. Withdrawal of my dog will not interfere with future care. I understand that investigators may continue to collect information from my dog’s medical record following withdrawal.
The study team reserves the right to remove my dog from this study for failure to meet study requirements or if it is in the best interests of my dog.
I may discuss this study with others and ask advice from my own veterinarian.
Someone may contact me after my dog has finished this study to collect follow-up information. This may occur several months to years following completion of the study.
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AT-NK Cell Phase I Clinical Trial for Canine Osteosarcoma
I have had time to ask questions regarding this study and feel comfortable moving forward with enrollment in this study based on the information provided.
I hereby grant to the College of Veterinary Medicine at The Ohio State University, Columbus, OH the right to publish, broadcast, web cast, or disseminate in any other form or medium any or all of the following:
• Stories, photographs, video, audio, and other images or likenesses of my animal for use in news stories, publications, promotional materials, including advertisements, web features and/or any other official purposes.
• I understand that I will not receive financial compensation for this use.
• All photographs, video, audio, images, likenesses, stories, and other materials will remain the property of The Ohio State University.
I/We grant permission for The Blue Buffalo Veterinary Clinical Trials Office to contact me/us with information regarding trial updates, future clinical trials and other clinical trial related news items.
□ Yes □ No E-mail
For additional questions or concerns about the study, please contact Dr. Kisseberth at 614-247-7201. Or if you would like to discuss any concerns with an individual not directly related with the study, please contact Ms. Lora Montgomery, Assistant Director, Customer Service at 614-292-5772 (Montgomery.1012@osu.edu)
As a result of discussion with , and after reading the above, I voluntarily consent for my dog to participate in this study and will follow the instructions of the study team, as it pertains to therapy and follow-up procedures. I certify that I am the legal owner/guardian of .
Signed
Owner or authorized agent of the owner
Date
Witnessed By: Date
***
1) After the first visit that I pay for there will be no more cost to me?
... will need to see Kookie once weekly for 14 weeks
then 8 weeks.
2) I live in Lancaster and would need to make sure about doing this.
3) ... I paid over $400 for xrays and an examine about a week ago would your docs like to view them
5) ... NOT cutting off her leg a possibility?
6) ... If they cut off Kookies leg what kind of things would I need to buy.. cart, harnass .. would this be another giant expense?
7) ... Dogs must undergo IF they die while on study
Would there be a cremation and ashes returned?
Hello Buddy,
Our best guess for the cost for the initial consult and testing would be around $1,000. Yes, she would likely be here for several hours to complete this testing. Would you like to get Kookie scheduled?
| 10:42 AM (1 hour ago) | ||
| |||
Hello,
Kookie would need to have a diagnosis of osteosarcoma to qualify for the trial, but it is ok if we do not have a firm diagnosis yet. That is what the consultation and testing will help us figure out!
Best,
***
OSU Oncology Appointment Confirmation for Kookie
|  10:09 AM (2 hours ago) | | ||
| ||||
This is confirmation that your pet, Kookie, has an appointment with The Ohio State University Veterinary Medical Center Integrated Oncology Services, at our Columbus location, 601 Vernon L. Tharp St.
Date: 3-21
Time: 8:45 AM
* Please bring your pet in fasted for this appointment. No food after 10 pm the night before, but water and regular medications are okay! (If your pet is diabetic, please let us know, as fasting instructions will vary).
*Please arrive on time for your appointment or you may be asked to reschedule. Also, if you arrive sooner than 15 minutes prior to your scheduled appointment time, you may be asked to wait in your car until it is time for your appointment.
* Please note the closure of Vernon L. Tharp St. Please see the attachment for detour directions.
So that we can facilitate others waiting for an appointment, if you are unable to keep this appointment, please call (614) 614-292-3551 to reschedule or cancel at least 48 hours prior to your appointment.
Our team looks forward to seeing your pet! In order to protect the health and safety of our clients and our team members, the Veterinary Medical Center has implemented the following COVID19 precautions:
- If you are experiencing ANY symptoms of illness, are under quarantine, or if you or anyone in your household have tested positive for COVID19, we respectfully ask that you contact us for CURBSIDE PROTOCOL instructions.
- Before entering the hospital lobby, we ask that you please use hand sanitizer, provided in our entryway, and wear a surgical facemask. If you need a surgical facemask, they will be available at the hospital entrance. We will not allow access to the VMC without a surgical facemask. Cloth masks are not permitted.
- Upon arrival, please check in at the front desk and you will be shown to an exam room
- A student or technician will greet you and your pet in the exam room and take a brief history. At this point, the pet will come back to the treatment area for the exam
- The student will relay the history and any concerns you may have to the doctor. Once the doctor has heard the case and examined your pet, the doctor will discuss the findings with you
- Please make sure you have your phone ON and be prepared to answer calls
- You may receive calls from an unknown number
- Once all diagnostics and/or treatments have been completed, you will be contacted by a team member to collect payment for your visit. Please allow a minimum of several hours for your pet’s appointment.
- The student will contact you to arrange pick up of your pet, answer any questions, and go over your discharge instructions.
- If you have any concerns during the course of your visit, please call 614-292-3551.
***
Your pet has an appointment with Integrated Oncology Services at The Ohio State University
Veterinary Medical Center, 601 Vernon L. Tharp Street
- Please arrive no sooner than 15 minutes prior to your scheduled appointment time. If you
are late, you may be asked to reschedule.
- In order to provide the best possible care, we require medical records before or at the
time of visit. If the pet has been seen at multiple hospitals, please supply records from all
locations.
- Please have records emailed (osuvet.oncology@osu.edu) or faxed (614-292-1454 attn:
oncology)
- If records are not available by the scheduled appointment time, diagnostics may be
repeated, or the length of time of your appointment may be extended.
Relevant medical records may include:
• Cytology
• Biopsy/histopathology
• Bloodwork
• Imaging (x-rays, ultrasound, CT)
• Other relevant medical records documenting diagnostics or treatment
• Current medications
So that we can facilitate others waiting for an appointment, if you are unable to keep this
appointment, please call (614) 292-3551 to reschedule or cancel at least 48 hours prior to your appointment.
If you are experiencing any symptoms, are under quarantine, or have tested positive for
COVID19, we respectfully ask that you contact us. You may either reschedule, or request our
Curbside Protocol, in which your pet will be collected from you and returned to you in your car.
Our team looks forward to seeing your pet! Here is what to expect the day of your appointment
(please note, that in order to protect the health and safety of our clients and our team members,
the Veterinary Medical Center has implemented COVID19 precautions):
- OSU is a teaching hospital for future doctors. Students will be working under the care
of a specialist doctor to learn. There will be a faculty member assigned to your pet’s
case as well a resident and a student.
- Please allow a minimum 4-5 hours for your appointment, especially if you plan to
pursue diagnostic procedures. Often, pets are not ready to go until about
midafternoon.
- Your pet needs to arrive fasted: no food after 10 pm the night before. Water and
regular medications are ok. If your pet needs food to take their medication, a small
meatball is ok. Please give the smallest amount of food possible.
o If your pet is diabetic, please make us aware, as fasting instructions may vary.
- All visitors must wear a surgical mask (not cloth) while in the building
- Upon arrival, please check in at the front desk and you will be shown to an exam room
- A student or technician will greet you and your pet in the exam room and take a brief
history.
- Your pet will then be escorted back to the treatment area for the exam, where the
student will relay your pet’s history and any concerns you may have to the doctor. The
team will discuss your pet’s case with students - this is part of the learning process.
- Once the doctor has heard the case and examined your pet, the doctor will discuss the
findings with you and develop a plan for the day.
- If you elect to pursue diagnostics the same day, this will extend your visit time with us.
As long as you are available to answer your phone, you do not need to wait on site for
the duration of the visit. Some choose to go home, to work, to the store, out to eat, etc
during the wait.
- Not all diagnostic tests can be completed on the same day as the initial consultation.
The team will arrange a date and/or time for those future tests, if that is the case.
- While your pet is with us, please make sure you have your phone ON and be prepared
to answer calls. You may receive calls from an unknown number. Failure to answer
our phone calls may extend your appointment time and/or delay diagnostics and
procedures.
- Once all diagnostics and/or procedures and/or treatments have been completed, the
student will contact you to arrange pick-up of your pet, answer any questions, and go
over your discharge instructions. You will also be contacted by a team member to
collect payment for your visit.
- If you have any concerns during the course of your visit, please call 614-292-3551
(option: oncology)
If surgery is warranted, this will be scheduled for a future date. Surgery
will not take place without having an initial consultation first, and
surgery will not take place the same day as the initial consultation.
Thank you! We look forward to helping your pet to the best health possible!
The first part of Kookie click here
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