ORBIT - VSV and an anti-PD-1 inhibitor for Canine 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, 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 aggressive lymphomas (LSA; B or T cell) with genetically modified Vesicular Stomatitis Virus (VSV), enhanced by adding a checkpoint inhibitor called anti-PD-1. 

  • Phase 1 will determine if VSV has efficacy as an individual treatment
  • Phase 2 will determine the safety and efficacy of a combination therapy using VSV and an anti-PD-1 inhibitor (B-cell only)

Eligibility criteria

Dogs should:  

  • have a previously confirmed diagnosis of aggressive lymphoma (B or T cell are eligible; any stage, substage a only)
  • have no previous treatment (naive disease) or have received at least one dose of chemotherapy then discontinued due to resistance (refractory disease) or disease progression (relapse)
  • be overall feeling well with no significant health concerns aside from lymphoma based on physical examination and laboratory
  • weigh between 16.5 lbs (7.5 kg) and 110 lbs (50kg)
  • be spayed or neutered
  • be up to date on vaccines, flea/tick prevention and internal parasite control
  • not be taking alternative/herbal medications or corticosteroids (some 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 are summarized below. Some patients will be given VSV alone and others will get the combination treatment which includes the anti-PD-1; detailed treatment plan will be discussed prior to enrollment:

  • Screening exam:  physical exam (PE); blood, urine and fecal samples collected; under general anesthesia, imaging of the chest and abdomen, and a lymph node biopsy will be taken
  • Week 1:  dogs will stay in the Veterinary Medical Center for 4 days (3 nights) to receive treatment with VSV (given IV) and/or anti-PD-1 inhibitor; observation and samples of blood, urine, saliva, and feces will be collected
  • Recheck visits:  weekly for the first month and then every 2-3 months for a year; PE with blood, urine and saliva collected
  • Restaging visits:  during recheck appointments on Days 49, 98, and 182; in addition to PE and sample collection, 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, all costs associated with visits and treatments pertaining to the study will be covered.

Phase 1 participants will receive a $5000 stipend for chemotherapy treatment if disease progression occurs. Treatment must be performed at the University of Minnesota to be covered by the stipend.