Oncology

Welcome to the Oncology Clinical Trials Page!

The following studies are currently recruiting patients.

Click on the study name for full information below:
 

1. An exploratory study of a novel therapy for dogs with lymphoma
2. OSAL: Safety and Tumor Response of Salmonella-IL2 in Combination with Adriamycin in Dogs with Appendicular Osteosarcoma
3. miR-31: Potential marker for pulmonary metastasis of canine osteosarcoma
4. SRCBST: dose-finding for a ligand targeted toxin to treat hemangiosarcoma 
5. Compassionate Use of TTG100 in Canine Cancer 

An exploratory study of a novel therapy for dogs with lymphoma 

Current Status: Active and enrolling
Principal Investigator: Antonella Borgatti, DVM, DACVIM (Onc)
Contacts: Amber Winter, study technician: 612-624-1352 or alwinter@umn.edu
Oncology service at 612-626-8387 (main VMC number)

The primary purpose of this study is to look at the safety and anti-tumor activity of an oral compound of a group called Selective Inihibitors of Nuclear Explort (SINE). This compound has shown evidence of anti-lymphoma activity in a pilot study conducted here and at other sites. Dogs with cancer and the dose of 1.5 mg/kg was found to be well-tolerated over 4-20 weeks of dosing when given on a Monday/Wednesday/Friday (MWF) basis. In dogs with lymphoma, partial shrinkage of lymph nodes and stable disease were noted in over half of the patients treated. Side effects from the drug given at this dose on a MWF basis included mild loss of appetite, occasional vomiting, and diarrhea, with some dogs experiencing an increase in thirst and an increase in urination. All of these side effects were mild and well-controlled with additional medications.

Inclusion criteria for dogs in this study (dogs we are looking for):

• Dogs with lymphoma, either newly diagnosed or in first relapse after completion of a single chemotherapy protocol (mulit-agent or single agent). Both types B and T cell accepted. 
• Dogs must have progressive disease (measurable lymph nodes)
• No anti-cancer therapy within the 2 weeks prior to enrollment
• Adequate organ function as indicated by standard laboratory tests
• Dogs must have estimated life expectancy of at least 28 days
• No serious other disease conditions

Dogs will receive study drug at a dose of 1.5 mg/kg orally once a day on M/W/F of each week. Dogs will visit the VMC weekly for the 28 days of the study. If a dog has either complete response, partial response or stable disease after the 28 days, the dog may continue treatment with visits every other week.  Tests will include bloodwork, urinalysis, and lymph node measurements.

These visits, study medication and adverse events related to the study medication are covered by the sponsor.

For more information, please contact the study team above.

OSAL: Safety and Tumor Response of Salmonella-IL2 in Combination with Adriamycin in Dogs with Appendicular Osteosarcoma 

Current Status: Active and enrolling
Principal Investigator: Vicki Wilke, DVM, DACVS
Contacts:
Amber Winter, study technician: 612-624-1352 or alwinter@umn.edu
Oncology service at 612-626-8387 (main VMC number)

Osteosarcoma (OSA) is the most common bone tumor found in the dog. In approximately 90% of dogs with OSA, the cancer has already spread by the time they are diagnosed. With surgery alone, dogs have a median survival of 3-4 months which increases to 9-14 months with chemotherapy. We are studying the use of an attenuated strain of Salmonella typhimurium conjugated to the IL2 gene (Salmonella IL2) in addition to standard of care in treating dogs with osteosarcoma. Salmonella-IL2 has been shown to be safe and to reduce tumor volume (size) in various animal species. There is an on-going early clinical trial in human patients with no toxicities noted thus far.

Patients for this study will be otherwise healthy, with OSA limited to one limb, whose owners are willing pursue the standard treatments of amputation and chemotherapy. We are looking for new cases, those that have not yet had surgery, chemotherapy or radiation treatments. In addition, patients will need to have a negative stool culture for Salmonella and not be on a raw diet.

GENERAL DESCRIPTION OF STUDY: an initial screening visit for an exam, x-rays, and lab tests. On Day 1, dogs will have a bone biopsy and be given their first dose of Sal-IL2. Patients will return on Day 3 and 7 for dosing and follow up. On Day 10, the amputation surgery will be performed. At three weeks out (Day 21) patients will receive a dose of Sal-IL2 and begin chemotherapy with Adriamycin. Day 28 will be the final study recheck, but dogs will receive Sal-IL2 and Adriamycin every three weeks for a total of five treatments.

PET-CT: Some of the patients enrolled in the study will be asked to let us perform PET-CT imaging. Positron Emission Tomography/ Computed Tomography is a special kind of imaging that allows us to assess metastasis or spread of the cancer. If the owner agrees, we will transport the patient to an imaging center on the Minneapolis campus at the beginning of the study and after 6 months of treatment.

COSTS: The study will cover costs from Day 1 on, including PET-CT, up to $2,000. Owners will be responsible for the prescreening/staging visit and costs beyond this amount.

miR-31: Potential marker for pulmonary metastasis of canine osteosarcoma 

Current Status: Active and enrolling
Principal Investigator: Fekadu Kassie, DVM, PhD
Contacts:
Sara Fritz, DVM: 612-626-4333 or sefritz@umn.edu
Amber Winter, study technician: 612-624-1352 or alwinter@umn.edu
Oncology service at 612-626-8387 (main VMC number)

This study will compare the expression level of miR-31 and its target genes in bone tissues and blood plasma from healthy dogs, primary osteosarcoma patients and primary osteosarcoma patients with a history of pulmonary metastasis. Currently we are enrolling dogs with osteosarcoma or suspect osteosarcoma that will have amputation. We will take a bone biopsy from the amputated limb, and collect a small blood sample. There is no cost for participating in the study.

Note, dogs in the OSAL study above are eligible for this study as well.

Return to top

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

Current Status: Active and enrolling
Principal Investigator: Jaime Modiano, VMD, PhD
Co-Investigators: Antonella Borgatti, DVM, DACVIM; Mike Henson, DVM, PhD, DACVIM
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) 

Hemangiosarcoma (HSA) is a type of sarcoma that is difficult to treat because of its aggressive behavior and rapid progression after diagnosis. We have shown that a bispecific targeted toxin (sarcoma bispecific targeted toxin, or SRCBST) is 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.

Dogs eligible for the study:

• diagnosed with HSA
• spleen removed by surgery either prior to study or at the Veterinary Medical Center
• no evidence of metastasis (on chest x-ray, ultrasound and/or seen during surgery)
• no concurrent kidney, liver or heart disease, or problems with blood clotting
• no previous chemotherapy (prednisone is ok), cyclophosphamides, or alternative medications*

The study involves:

• PET-CT prior to start of treatment. This imaging will allow us to look for micro-metastasis but will not exclude dogs if any are found. We will transport the dog to the Mpls campus Center for Clinical Imaging Research (CCIR), perform the PET-CT under general anesthesia, then return the dog to the VMC. CIC staff will remain with the dog throughout this procedure.
• Day 1, 3, 6 visit the VMC for SRCBST administration and follow up blood testing
• Day 8 recheck visit
• Day 21 - chemotherapy begins, continues for total of 5 treatments, 3 weeks apart
• Month 6 follow up

The study covers the costs of prescreening diagnostics, study visits day 1-8, study drug, PET-CT and blood sampling. The owner is responsible for the initial oncology exam fee. The covered costs are equivalent to approximately $3800-$9560 in value. In addition, the study covers up to $3300 of chemotherapy treatment, which will be most if not all of the cost.

*Herbal medications such as Yunnan Bai Yao will have to be stopped prior to enrollment. 

Return to top

Compassionate Use of TTG100 in Canine Cancer 

Current Status: Active and enrolling
Principal Investigator: Mike Henson, DVM, PhD, DACVIM
Co-Investigator: Antonella Borgatti, DVM, DACVIM
Contacts:
Dr. Henson, henso001@umn.edu
Amber Winter, study technician: 612-624-1352 or alwinter@umn.edu
Oncology service at 612-626-8387 (main VMC number) 

This is a pilot study of new drug, TTG100, given orally to treat a variety of malignancies. Preliminary studies have shown this drug may help control some cancer types that are notoriously difficult to treat in dogs, such as histiocytic sarcoma. The results of this study will help assess the safety or oral and intravenous (IV) TTG100 (given in 1 dog), and identify which tumor types are most susceptible.

Dogs eligible for the study:

• Histological or cytological diagnosis of any malignancy, naïve or relapsed, which can be accurately measured directly with a caliper, via radiographs, or via abdominal ultrasound
• Any breed, at least one year of age, between 15 - 50 kg (33 – 110 lbs)
• Otherwise feeling well, adequate organ function, life expectancy at least 8 weeks
• Not intended for breeding, pregnant, lactating
• No treatment in previous 3 weeks using chemotherapy, immunotherapy, radiation therapy, or any investigational drug (non-steroidal anti-inflammatory medications are acceptable)
• No complementary care which would affect the assessment of toxicity or antitumor activity of the study drug

Study details:

• Oral drug given at home; owners will log all drug administration and any reactions
• Five visits (planned) to the Veterinary Medical Center over about 3-4 months
• Blood draws for pharmacokinetics (PK) over 2-4 hour period at all visits
• Thoracic (chest) radiographs, ECG, abdominal ultrasound (if needed to assess tumors) at two visits
• Possibility to continue study drug if stable disease or good response after last day

Compensation and costs to the owner:

• Study covers costs of TTG100, PK blood draws and a portion of ECG
• $1000 credit to owners, paid $500 at enrollment, and $500 at closeout (Day 99 of study) to assist with remaining costs of study
• Owners are responsible for initial screening and diagnosis (approx. $1500-$2000), study exams, blood and urine tests, chest radiographs, ultrasounds, anti-nausea drugs and other supportive medications needed ( approx. $2000-$3000)
• Owners are responsible for any costs of adverse effects, even if related to the drug  

For more information or to enroll a dog, please contact the study team above.

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 and Radiation Therapy department at the Veterinary Medical Center, go here.

You may also Contact Us at the CIC.