CIC
What's Inside


College Links

 About

 Directory

 Employment

 Map/Directions

 Volunteer

Search

 

 

Make a Gift box


 

 
  Home > Current Clinical Trials > Oncology
 

Oncology

CVM2 CVM NewsCalendar - Image - Modiano-golden

Welcome to the Oncology Clinical Trials Page!

The following studies are currently recruiting patients. Click on the study name for full information below:

REV02: An exploratory study evaluating the safety and efficacy of a selective PI3K inhibitor, in dogs with T- or B- cell lymphoma

SRCBST: dose-finding for a ligand targeted toxin to treat hemangiosarcoma

Early detection to Target Hemangiosarcoma Cells in Dogs: The Shine On Project

To find out how to donate samples for veterinary oncology research, see Modiano Lab Study Info.
 



REV02: An exploratory study evaluating the safety and efficacy of a selective PI3K inhibitor, in dogs with T- or B- cell lymphoma

Current Status: Active and enrolling
Principal Investigator: Claire Cannon, BVSc(hons), DACVIM
Contacts: Dr. Cannon, at the Oncology Service: 612-626-8387
               Amber Winter, research study technician: 612-624-1352 or alwinter@umn.edu

Purpose: A three month study to evaluate the safety and efficacy of a drug called a PI3K Inhibitor in dogs with lymphoma. Dogs  benefiting from treatment will have the option to continue on the study agent. The study drug is given orally in clinic and by the owner at home.

Dogs needed: Naive (newly diagnosed) or first-relapsed dogs with lymphoma (B-cell or T-cell) are eligible. Dogs must be over 1 year old, otherwise healthy. A screening visit will determine the dog's eligibility with exam, blood and urine tests, chest x-ray (if not performed recently), and flow cytometry. No other treatment such as chemotherapy, immunotherapy or radiation therapy will be allowed while on the study.

Study activities: Screening visit followed by enrollment visit within a week; then weekly visits for first 4 weeks; visits every other week for six more weeks. Dogs showing partial or complete response or stable disease will have the option to continue until the dog is no longer showing benefit from the study treatment. The study drug is given by mouth at home on an empty stomach each morning on a strict schedule (normally 4 days on and 3 days off). Owners will keep a diary of giving the study drug administration. All other medications must be discussed with the study team.

Compensation: All study required activities are fully-funded by the sponsor for the first 3 months of the study. This includes screening procedures and management of adverse reaction to the study drug (if present).

To enroll or to learn more about the study, please contact Amber Winter, research study technician, or Dr. Claire Cannon.

Return to top


SRCBST2: dose-finding for a ligand targeted toxin to treat hemangiosarcoma 

Current Status: Active and enrolling
Principal Investigator: Jaime Modiano, VMD, PhD,
Contacts: Dr. Modiano: modiano@umn.edu
Amber Winter, study technician: 612-624-1352 or alwinter@umn.edu
Oncology service at 612-626-8387 (main VMC number) 

The study: SRCBST2 is a continuation of the first SRCBST study. The first 21 dogs with hemangiosarcoma treated in the SRCBST trial showed that the drug is safe and doubles the expected survival time.  This significant gain in the treatment for this disease is encouraging, and it strengthens our resolve to continue our efforts to improve survival and maintain quality of life for dogs with hemangiosarcoma.

Hemangiosarcoma is a type of sarcoma that is difficult to treat because of its aggressive behavior and rapid progression after diagnosis. SRCBST is a sarcoma bispecific targeted toxin that has been shown to be safe in other species and that it can kill hemangiosarcoma cells in the laboratory. This is a dose-finding trial to determine the safest dose of SRCBST which is still effective. Results of this study will provide information to develop a therapy for both dogs and humans with this incurable disease.

Eligible dogs:

  • Hemangiosarcoma restricted to the spleen, which will be treated by removal of the spleen prior to enrollment in the study
  • If any gross metastasis are surgically removed at the time of splenectomy, dog may still be eligible
  • Adequate supply of blood cells
  • No concurrent kidney, liver, heart disease, or problems with blood clotting
  • No previous chemotherapy, no alternative medications
  • OK to be on prednisone or Non-steroidal anti-inflammatory drugs (NSAIDS)

Visits:

  • PET-CT (optional but desired): A week to two weeks after surgery, drop off dog for the day and overnight. We transport to imaging center on the Mpls campus (Center for Magnetic Resonance Research), provide anesthesia, stay with the dog during procedure, then return to VMC. Dogs stay overnight due to radioactive contrast used for the PET-CT, needs to be eliminated before the dog can go home.
  • Day 1, SRCBST treatment 1: drop off for the day, we collect blood, give first dose of SRCBST through intravenous catheter, collect small amounts of blood for following to help us assess the pharmacokinetics and drug distribution
  • Day 3, SRCBST treatment 2: Same as Day 1 but no extra blood draws, drop off for the day
  • Day 5, SRCBST treatment 3: Same as Day 1 but no extra blood draws, drop off for the day
  • Day 8, Recheck and begin chemotherapy
  • Day 21: 2nd PET-CT (if first one was done, and we saw evidence of micro-metastasis)
  • Day 25-29: second round of SRCBST treatment, coincides with 2nd round of chemotherapy
  • Chemotherapy continues for total of 5 doses, every 3 weeks
  • Day 88-92: Possible third round of SCRBST at the time of the 5th chemotherapy, depending upon restaging results (bloodwork, X-ray, ultrasound)

Costs of the study: Owners pay for splenectomy surgery (estimated $3,800-$4,600 for surgery at the VMC) and initial oncology exam fee and staging diagnostics (approx $900-$1,100). If the dog is eligible, the study reimburses the owner for prescreening chest x-rays, abdominal ultrasound, bloodwork, urinalysis, then covers PET-CT and all visits listed above. This is a $8,500 - $9,560 value. In addition, the study will cover up to $5,000 in chemotherapy costs (covers most if not all of chemotherapy depending upon the size of the dog).

To enroll or learn more about the study, please contact Amber Winter or Dr. Modiano (above).

Results of the first SRCBST study were presented on April 20, 2015 at the American Association for Cancer Research conference in Philadelphia, PA. See the poster here.

Early detection to Target Hemangiosarcoma Cells in Dogs: The Shine On Project

Current Status: Opens March 1, 2016
Principal Investigator: Jaime Modiano, VMD, PhD
Contacts: Dr. Modiano: modiano@umn.edu
For clinical trial: Amber Winter, research study technician: 612-624-1352 or alwinter@umn.edu
For sample submission: Mitzi Lewellen, Modiano lab, 612-626-6890 ext 1 or lewel001@umn.edu 

What is the project?

Can my dog participate (Study details)?

How can I support this project?

What is the project? "Early Detection to Target Hemangiosarcoma Cells in Dogs (Shine On)" was conceived to reduce the mortality and the suffering caused by canine hemangiosarcoma.

Canine hemangiosarcoma is an incurable disease, partly because this insidious cancer almost always grows out of sight without causing pain or obvious symptoms. This means it is diagnosed at a late stage when it is resistant to conventional therapies, and often only after it causes the death of the dog. There have been virtually no gains against the clinical outcome of this disease since chemotherapy was adopted as part of the standard of care forty years ago. However, we have made significant strides to understand the biology and the behavior of this disease over the past decade, and these are the basis of a new approach to improve the outcomes for dogs at risk of hemangiosarcoma.

The goal of this project is to develop effective methods for early detection and for prevention of canine hemangiosarcoma. We will use a blood test to look for the cells responsible for establishing and maintaining the disease, and then use an experimental drug treatment that attacks those same cells in order to prevent development of the tumor. We believe that reducing the number of dogs that ever get hemangiosarcoma provides the best chance to reduce the death and the suffering from this disease.

The project will have three phases and is expected to continue for at least three years.

  • Phase-1: test the performance of the blood test in dogs that have been diagnosed with hemangiosarcoma. We will also include healthy dogs and dogs with other tumors to define the best parameters for use of this test. (Begins March 1, 2016)
  • Phase-2: determine if the test can be used to predict when a dog in remission might relapse. This would allow us to consider changes in the management or therapy to extend remission or prevent unexpected, life-threatening bleeding episodes. Phase-2 will re-test dogs enrolled in Phase-1.
  • Phase-3: establish the performance of the test in the early detection setting and implement hemangiosarcoma prevention through eradication of the tumor initiating cells with a novel targeted drug. This phase will include pedigreed Golden Retrievers, Portuguese Water Dogs, and Boxers at risk of developing hemangiosarcoma that do not have evidence of active disease. (Expected to begin between March and October, 2017)

At the end of the project, we expect to have proof of concept that will inform how we can deploy this approach on a larger scale.

Return to top of study

Can my dog participate?
Each phase of the project will have specific eligibility requirements.

Phase-1, begins March 1, 2016. Phase-1 is designed to refine the hemangiosarcoma diagnostic blood test. Dogs will be limited to those seen at the Veterinary Medical Center of the University of Minnesota. Dogs will be eligible if they fall into one of the four following categories:

Category-1. Dogs with confirmed hemangiosarcoma. This group will include dogs that have a pathologically confirmed diagnosis of hemangiosarcoma from any anatomical site, at any stage of disease, of any pathological grade, and dogs can be of any breed, age and sex as long as samples are obtained prior to removal of gross tumor burden (primary or recurrent). Dogs in this group will be re-tested every 60 days (see Phase-2 below). We expect to recruit 25 dogs into this group over the first 12-18 months of the study.

Category-2. Dogs with confirmed non-neoplastic (non-cancerous) splenic lesions. This group will include dogs that have a pathologically confirmed diagnosis of splenic nodular hyperplasia and/or splenic hematoma and/or splenic hemangioma. The disease can be at any stage and dogs can be of any breed, age and sex as long as samples are obtained prior to splenectomy. Dogs in this group will be re-tested at 6-month intervals. We seek to recruit 25 dogs into this group over the first 12-18 months of the study.

Category-3. Dogs with any confirmed cancer other than hemangiosarcoma. This group will include dogs that have a pathologically confirmed diagnosis of cancer other than hemangiosarcoma, specifically malignant lymphoma (any subtype), osteosarcoma, soft tissue sarcoma, or carcinoma. The cancer can be in any anatomical site, at any stage, have any pathological grade, and dogs can be of any breed, age and sex as long as samples are obtained prior to removal of gross tumor burden (primary or recurrent). Dogs in this group will be re-tested at 6-month intervals. We expect to recruit at least 25 dogs, and potentially up to 75 dogs into this group over the first 12-18 months of the study.

Category-4. Healthy young dogs. This group will include young dogs (under four years of age) with no evidence of any disease recruited from our general practice well-health program and from the hospital staff pet population. Dogs in this group will be re-tested at 6-month intervals. We expect to recruit at least 25 dogs into this group over the first 12-18 months of the study.

If you are interested in having your dog participate in this phase of the study, please contact Amber Winter (see above).

Phase-2 is designed to determine the ability of the diagnostic blood test to predict relapse in dogs with hemangiosarcoma that are undergoing treatment. This phase will begin shortly after recruitment for Phase-1 has started, will be limited to dogs recruited as part of Phase-1, and will be completed at the end of year-3 by re-testing dogs in each of the four groups described above.

Phase-3, expected to start between March and October, 2017. This phase is designed to determine the usefulness of the diagnostic test for early detection of hemangiosarcoma, and to confirm that the experimental drug can prevent development of the tumor. This phase will start at the end of Phase-1, in approximately 12-20 months (expected between March and October of 2017) and will continue through the end of year-3. It will be open to dogs at risk for hemangiosarcoma that meet the criteria below; enrollment will use a proportional formula.

In order to participate in Phase-3 testing, a dog must:

  • be an AKC-registered Golden Retriever, Portuguese Water Dog, or Boxer. Dogs that are not registered with the AKC will be eligible if they have a pedigree to confirm they are from one of these three breeds.
  • be at least 6 years old at the time of enrollment
  • be any sex (intact or neutered)
  • Owners must agree to submit blood samples for re-testing according to the study guidelines. Each instance of testing will involve submission of blood samples by priority (overnight) courier as described in the Informed Consent Form and in the Detailed Instructions.

Results of testing will only be provided to the licensed veterinarian that is responsible for the care of each participant. The study will cover costs to ship samples, but the family will be responsible for office visits, procedures, and any follow-up diagnostics.

If you are interested in allowing your dog to be tested, please contact Mitzi Lewellen at lewel001@umn.edu, after March 1, 2017.

In order to participate in Phase-3 treatment a dog must:

  • have two successive positive test results
  • have no evidence of a detectable tumor (based on imaging studies)
  • be able to receive treatment at the University of Minnesota: experimental treatment will be offered only at the Veterinary Medical Center of the University of Minnesota; each cycle will require at least three visits over a 5-day period.

The experimental treatment will be optional, and it will not be offered to dogs that test negative. The costs of treatment will be covered by the study, but the family will be responsible for all other office visits, procedures, and any follow-up diagnostics.

If you are interested in considering experimental treatment for your dog, please contact Amber Winter at alwinter@umn.edu after March 1, 2017.

Return to top of study

How can I support this project?
You can support the project by allowing your dog to participate, if eligible, by telling your friends and family about the study and encouraging them to allow their dogs to participate, if eligible, and by providing financial support that will help us expand and accelerate recruitment and progress. If you wish to contribute financially to the study, please contact Andrea Fahrenkrug at afahren@umn.edu or follow this link to the Modiano research fund.

Return to top

For more information on cancer research at the College of Veterinary Medicine, please go to the Animal Cancer Care and Research site.

For information on the Oncology department at the Veterinary Medical Center, go here.

You may also Contact Us at the CIC.

 

 

Notice of Privacy Practices