Natural killer cells (NK cells) are a type of white blood cell, and a component of the natural defense system (immune system) that control several types of tumors and infections by limiting their spread.
In recent years, the use of treatments that boosts the body’s natural defense system (immunotherapy), have made significant advances in people, and there is evidence to suggest that bone tumors can be susceptible to this type of treatments.
The purpose of this study is to establish the effectiveness of natural killer (NK) cells from healthy dogs given in combination with chemotherapy to dogs with bone tumors (osteosarcoma).
What qualifies my pet for this trial?
Eligible patients (any breed of dog) must meet all of the following criteria:
- Confirmed osteosarcoma (Histologically or cytologically)
- Weight at least 25kg
- Measurable disease that is amenable to surgical removal via amputation (No evidence of metastasis based upon physical exam and thoracic CT).
- ONLY newly diagnosed dogs are eligible with no prior therapy (conventional or metronomic chemotherapy, ionizing radiation, bisphosphonates) for osteosarcoma
- Dogs receiving analgesics including NSAIDs, gabapentin, tramadol, or other will be eligible for study inclusion
- Dogs must undergo full post-mortem examination (necropsy) if they die while on study
What does enrolling in this clinical trial involve?
Dogs enrolled in this trial will undergo standard of care treatment for osteosarcoma. This includes amputation of the affected limb, followed by 4 doses of intravenous carboplatin chemotherapy given on an every 21 day schedule.
- A dose of NK cells will be given (Intravenously) to your dog 24 hours prior to limb amputation.
- Blood samples will be obtained immediately prior to the NK cell infusion, 8 hour post infusion, immediately prior to surgery and 24 hours after NK cell infusion.
- NK cells will be infused post-operatively at 2-4 hours, 24 hours, and 48 hours post-amputation (total of 3 doses) and additional blood samples obtained.
- On weeks dogs are not receiving carboplatin they will receive a dose of NK cells intravenously.
- After completion of all 4 cycles of adjuvant carboplatin/ NK cell therapy, dogs will be restaged and confirmed as having no evidence of disease based on thorough physical examination and 3-view thoracic radiographs.
- Follow-up visits every 8 weeks are required after completion of chemo-immunotherapy for physical examination, CBC, correlative sample collections, and thoracic radiographic examination.
Owners are responsible for all costs associated with determining trial eligibility (e.g. initial office visit, bone aspirate or biopsy, cytology/histopathology, screening bloodwork) amputation and supportive care medications.
For eligible, enrolled dogs, the clinical trial will cover all scheduled study costs (carboplatin chemotherapy, NK cell infusions, CBC, chemistry profile, and recheck thoracic radiographs). In the event of side effects/toxicity, up to $500/patient will be provided to manage these events.
If you believe your pet may be eligible to enter this study,
please fill out a pre-screening questionnaire.