Exploratory safety study of an intravenous infusion of a novel therapeutic agent for the treatment of melanoma, osteosarcoma, soft tissue sarcoma or squamous cell carcinoma in dogs: A multi-center study

This Clinical Trial is Closed.

Purpose

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.

Background

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.

Inclusion criteria

To qualify for enrollment in this study, dogs must have:

  • Histologic or cytologic diagnosis of cancer (biopsy or needle aspirate)
  • There is at least 1 tumor (melanoma, osteosarcoma, soft tissue sarcoma, or squamous cell carcinoma) which can be measured (minimum 1 cm in diameter)
  • Generally feeling well (i.e. eating, drinking, ambulating on their own, etc.)
  • No evidence of an active bacterial infection requiring antibiotics (other than topical medications) in the past 7 days
  • No anti-cancer therapy within the past 21 days. This includes chemotherapy, radiation therapy, prednisone (or other forms of corticosteroids), and immunotherapy
  • No tumors where abscess (infection) would result in major symptoms

Study Design

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.

Client Compensation

  • The study sponsor will pay for therapeutic agent, diagnostic tests, and follow-up evaluations. In the event that side effects are noted and attributed to the therapeutic agent, the study will pay for medical management of the side effects.

Contact Information

For more information, pleaswe contact Nicole Stingle or Tamra Mathie at clinicaltrials [at] cvm [dot] osu [dot] edu