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The primary objective of this multi-institutional exploratory study is to describe the safety and efficacy of three dosages of an intravenous infusion of C. novyi-NT spores, with and without concomitant therapy, in dogs with spontaneous tumors.
Currently enrolling dogs for a nationwide clinical trial to evaluate a novel cancer treatment for measurable melanoma, osteosarcoma, soft tissue sarcoma, or squamous cell carcinoma. The goal of this therapy is to specifically target the tumor and induce an inflammatory response. The proposed benefit of such a response is to shrink existing tumors and reduce or eliminate microscopic cancer cells that may not be visible by standard (or any) means. The purpose of this study is to assess the safety and potential effectiveness of this therapeutic agent in dogs.
The therapeutic agent is a modified anaerobic bacterium. In previous trials, it has been shown to target the necrotic center of malignant tumors, leading to tumor regression or stable disease in many of the small mammals tested. Common side effects include fever, nausea and inflammation.
To qualify for enrollment in this study, dogs must have:
Dogs must have spontaneous measurable melanoma, osteosarcoma, soft tissue sarcoma, or squamous cell carcinoma. “Measurable” may be a primary tumor or a metastatic lesion. Dogs that meet the eligibility criteria will be treated with a single intravenous infusion of the therapeutic agent. Treated dogs will require close monitoring for 6 hours after treatment with follow-up visits required 2, 4, 7 and 14 days post-treatment. While the patient remains on study, there will also be rechecks at 1 and 2 months. In some study dogs, medications in addition to the therapeutic agent will be used.
For more information, pleaswe contact Nicole Stingle or Tamra Mathie at clinicaltrials [at] cvm [dot] osu [dot] edu