Kv9 Clinical Trial
Study purpose
To establish initial safety and efficacy data of two formulations (Kv9-A /B) in canine soft tissue sarcomas
Potential benefits
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All dogs will receive three rounds of the experimental Kv9 treatment, without charge. This treatment has the potential to provide stable disease, which means the tumour doesn’t grow any further. In the case of Kv9 treatment being combined with surgery it has the potential to prevent reoccurrence.
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All dogs in the study will still receive the current normal standard of care, including surgery if elected. The cost of concurrent treatment is the responsibility of the owner.
Eligibility criteria
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Your dog must have a suspected soft tissue sarcoma (must be assessed by a veterinarian).
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They must not require urgent complete surgery (>30days)
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Dogs who have undergone or will undergo surgery will still be considered if they have at least 1cm x 1cm of tumour remaining.
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They must be expected to survive 3 months minimum.
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The tumour is required to be (approximately) greater than minimum size of 1cm x 1cm and there is no minimum or maximum weight for the animal as long as the tumour is of appropriate size.
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The tumour must not have any wounds on the surface.
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They must not be receiving chemotherapy or immune modulatory drugs (prednisone etc), pregnant or lactating.
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Your dog must not have 3 or more different types of cancers.
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This excludes lipomas (fatty masses) and sebaceous adenomas (wart like growth).
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Your dog must not also have a mast cell tumour currently present.
Whats involved?
Your dog will undergo screening and planning prior to admittance to the study to determine if they fit the eligibility criteria, this includes blood testing and a tumour sample. There is no charge or cost to you for this.
If enrolled in the study, your dog will receive several small injections (about 0.1mL at each site) of a Kv9 solution directly into their tumour mass every 10-14 days (on three occasions).
In addition, there will be several follow-ups over the next two years to monitor their disease progression (there will be no charge for these follow-up appointments). The study ends after the last monitoring visit.