ORBIT - VSV and an anti-PD-1 inhibitor for Canine Lymphoma
Kelly Reid, CVT
Senior Research Study Technician
[email protected]
612-625-7645
Study title
Translation of a novel combination therapy approach for non-Hodgkin lymphoma
Phase 2: Combination therapy for naive or relapsed/refractory aggressive 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 - COMPLETED
- Phase 2 will determine the safety and efficacy of a combination therapy using VSV and an anti-PD-1 inhibitor - currently enrolling
Eligibility criteria
Dogs should:
- have a previously confirmed diagnosis of aggressive lymphoma (indolent lymphomas are excluded)
- have treatment naive or received at least one dose of chemotherapy then discontinued due to resistance (refractory disease), disease progression (relapse), or severe toxicity
- be overall feeling well with no significant health concerns aside from lymphoma based on physical examination and laboratory testing
- weigh at least 16.5 lbs (7.5 kg)
- be spayed or neutered
- be up to date on vaccines, flea/tick prevention and internal parasite control
- not be taking alternative/herbal medications
- not be taking corticosteroids, unless part of CHOP treatment
- not be housed near or otherwise have access to livestock or companion horses, goats, pigs (VSV is a potential concern in livestock) for at least 4 days post VSV administration
- discontinue any immunosuppressive drugs for two weeks prior to enrolling in the study
Procedures
The procedures during the study visits are summarized below. Patients will be given a combination treatment with VSV and the anti-PD-1; a 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
- VSV administration - Day 0: dogs will receive VSV (given IV) and stay at least 6 hours for observation and periodic sample collection which may include blood, urine, feces and saliva; dogs will either need to return everyday for the next 4 days or stay in the hospital for a PE and sample collections
- Anti-PD-1 administration - Days 2, 16, 44, 100: dogs will receive anti-PD-1 antibody IV and monitored closely for a minimum of 2 hours; a PE and blood, urine and feces will be periodically collected over 6 hours
- Lymph node resection - Day 10: surgery service will remove a previously affected lymph node, if one is visible and accessible, under general anesthesia
- Recheck visits - multiple, discussed at enrollment: PE with blood, urine, feces and saliva collected; lymph node measurements and aspirates performed during some visits
- Restaging visits -multiple, discussed at enrollment: during some recheck appointments, 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 with an anticipated maximum of $10,500.