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Evaluating a new drug for the treatment of mast cell cancer and other solid tumors

Phase I study of ART 207 in Dogs with Cutaneous Mast Cell Tumors and Solid Tumors

Status: Suspended

Species: Dog

Veterinary Speciality: Oncology

Description

The purpose of this clinical trial is to evaluate the activity of new formulation of an old chemotherapy drug called paclitaxel in dogs with mast cell tumors.  Paclitaxel is not water soluble and therefore needs to be formulated with a chemical that permits intravenous administration.  ART207 is a new formulation of paclitaxel in which the drug is encapsulated in a lipid (fat) protein complex designed to promote specific uptake of the complexes through cholesterol receptors that are expressed in tumors.  ART207 results in much higher exposures to paclitaxel than the previous formulations and may have greater anti-tumor activity in dogs with cancer.

The ultimate goal of this clinical trial is to shrink your dog’s tumor by using a novel formulation of paclitaxel that selectively targets the tumor cells, thereby reducing systemic side effects. As paclitaxel is known to have activity against tumors in dogs, it is likely that ART207 will have equivalent or superior activity to paclitaxel given its higher drug exposures.

Inclusion Criteria

  • Dogs must have a cytologic or histopathologic diagnosis of mast cell tumor. The dog may have failed standard therapy, or there may be no other known effective antineoplastic therapeutic options, or the owner may elect to enter the patient in lieu of standard therapy.
  • Dogs must have measurable tumor at least 2 cm in size or greater
  • Dogs must be greater than 1 year of age
  • Dogs must weigh at least 5 kg
  • Dogs must have adequate organ function as indicated by standard laboratory tests (complete blood count, serum biochemistry profile, urinalysis).
  • Dogs must be medically healthy with no clinically significant physical findings upon examination, medical history, and clinical laboratory profile, as deemed by the principal investigators.
  • Dogs must have an estimated life expectancy of at least 28 days.
  • Prior chemotherapy or radiation must be completed 2 weeks prior to study entry and the patient must have recovered from the acute toxicities of these treatments.
  • Informed written consent must be obtained
  • Dogs must be able to return for study visits as dictated by the study calendar

Exclusion Criteria

  • Pregnant or lactating dogs
  • Any abnormality on the CBC or chemistry panel deemed to be significant by the principle investigator
  • Concurrent use of complementary or alternative medicines that in the opinion of the principal investigators would confound the interpretation of toxicities and/or antitumor activity of the study drug.
  • Dogs with significant liver, cardiac and/or renal disease
  • Less than 2 weeks from a major surgical procedure.
  • Any serious systemic disorder incompatible with the study (at the discretion of the principal investigators).
  • Use of any other investigational drug within 1 week of study entry.
  • Dogs with evidence of systemic mast cell disease (i.e., spread to the liver, spleen, bone marrow, etc).

Client Benefits

The study will cover all diagnostics (bloodwork, imaging, biopsies, etc) and treatments (ART207 administration, supportive medications) associated with the tumor while your dog is enrolled in this study as well as the management of any study-related side effects. Except for the specific financial support described here, any tests or procedures unrelated to this study including treatment of conditions unrelated to the mast cell tumor are your responsibility.

Contact Info

For questions regarding the clinical trial please email the clinical trials technician, Diane Welsh at: clinicaltrials@tufts.edu

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