ORBIT - VSV and ONIx for Canine B-cell Lymphoma

cartoon dog in space
Principal Investigator
Jaime Modiano, VMD, PhD
Perlman Professor of Oncology and Comparative Medicine, Veterinary Clinical Sciences
Co-investigator

Caitlin Feiock, DVM
Assistant Professor, Department of Veterinary Clinical Sciences
[email protected]

Contact

Kelly Reid, CVT
Senior Research Study Technician
[email protected]
612-625-7645

Category:
Cancer/Oncology
Species:
Dog
Current status: Open and enrolling

Study title

Translation of a novel combination therapy approach for non-Hodgkin lymphoma

Purpose of study

NEW experimental treatment for dogs with relapsed or refractory diffuse large cell B-cell lymphoma (DLBCL) with genetically modified Vesicular Stomatitis Virus (VSV), which we will enhance by adding a new molecule that increases the anti-tumor immunity, called onco-immune accelerator (ONIx). 

  • Aim 1 will determine if VSV and ONIx each have efficacy as individual treatments 
  • Aim 2 will determine the safety and efficacy of combination therapy using VSV and ONIx 

Eligibility criteria

Dogs must:  

  • previously confirmed diagnosis of large B-cell lymphoma, substage a 
  • have received at least one dose of cytotoxic chemotherapy (discontinued because of resistance, disease progression, or severe toxicity) and have evidence that the cancer did not respond to therapy
  • be overall feeling well with no significant health concerns aside from lymphoma based on physical examination and laboratory 
  • weigh between 7.5 kg - 50kg (16.5 - 110 lbs); over 50kg may be enrolled at investigation teams discretion
  • be spayed or neutered
  • be up to date on vaccines, flea/tick prevention and internal parasite control 
  • not be taking alternative/herbal medications; corticosteroids (prednisone, prednisolone, dexamethasone, etc.) are ok as part of CHOP treatment
  • not be housed near or otherwise have access to livestock (VSV is a potential concern in livestock) 
  • discontinue any immunosuppressive drugs for two weeks prior to enrolling in the study 

Procedures

The visits for the study include (summary). Some patients will be given VSV, some ONIx, and some both; detailed treatment plan will be discussed prior to enrollment:

  • Screening exam will include blood, urine and fecal samples collected, imaging of the chest and abdomen under general anesthesia, and a lymph node biopsy. 
  • Week 1:  Monday – Friday dogs will stay in the Veterinary Medical Center to receive treatment with VSV (given IV) and/or ONIx (given under the skin) and observation. Dogs getting VSV will receive it on Monday. Dogs getting ONIx will receive it on Wednesday and Friday. Samples of blood, urine, saliva, feces will be collected.
  • Recheck visits on Day 7, 10, 14, 28, 49, 70, 98, 182 (6 months), 365 (year) will include exam with blood, urine and saliva collected. ONIx treatments and restaging (see below) may also be preformed. 
  • ONIx treatments will be given during recheck appointments on Days 7, 28, 49, and 70. Dogs will stay a minimum of two hours post-treatment for observation, owners can drop them for their convenience.
  • Restaging will happen during recheck appointments on Days 49, 98, and 182. They will include imaging of the chest and abdomen under general anesthesia if needed. Possible tissue biopsy if lymph nodes are enlarged. 

Costs

Owners are responsible for the initial diagnostic exam, bloodwork and urinalysis during the screening visit. 

Once a patient is enrolled, the study will cover all costs associated with visits and treatments pertaining to the study.