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New drug treatments for osteosarcoma (bone cancer) with spread to the lung

Optimizing Novel Immunotherapy Combinations Targeting the Tumor Microenvironment in Canine Spontaneous Osteosarcoma

IACUC Protocol #: G2017.129

Status: Recruiting

Species: Dog

Veterinary Speciality: Oncology

Description

The purpose of this clinical trial is to evaluate the activity of new immunotherapy agents for the treatment of osteosarcoma that has spread to the lungs.  The ultimate goal is to find drug combinations that either stop the growth of tumor spread or that actually shrink the spread by stimulating the immune system to control the cancer.

Your dog will undergo several blood tests/diagnostics prior to and during the course of treatment to monitor blood counts and collect plasma/blood for additional genetic analyses. These blood draws amount to approximately 2 tbsp. of blood at each visit. Your dog’s treatment for osteosarcoma will involve the administration of two drugs orally at home to help control the cancer: toceranib (Palladia) and losartan. Palladia received FDA approval to treat mast cell tumors in dogs in 2009. Since then it has been used to treat several types of cancer in dogs. Losartan is a generic version of a drug called Cozaar which is used to treat high blood pressure in people. Both drugs have been tested extensively in dogs with cancer either alone or in combination to ensure that the dose being given is safe.

Inclusion Criteria

  • At least one year old on Day 0 and weigh at least 10 kg (22 lbs)
  • All dogs must have had surgical resection of the primary tumor with a histologically confirmed diagnosis of OSA.
  • All dogs must have measurable pulmonary metastatic disease, documented by thoracic radiographs.
  • Prior chemotherapy (or other specific therapy for OSA) or any other anti-cancer therapy is acceptable with a 2-week washout from prior treatment.
  • Dogs must have adequate organ function as indicated by standard laboratory tests: (hematology (CBC), clinical chemistry and urinalysis).
  • The animal must have a performance status of either 0 or 1 on Day 0, according to the modified ECOG Performance Scheme.
  • The Owner must have provided written, informed consent prior to enrolling in the study.

Exclusion Criteria

  • Dogs that have received chemotherapy within 2 weeks of Day 0.
  • Concurrent malignancy, or other serious systemic disorder incompatible with this study.
  • Dogs that are on homeopathic/alternative therapies for OS. These treatments should be discontinued on Day -1. Supplements such as chondroitin sulphate, vitamins, essential fatty acids and glucosamine are permitted during the trial period. Pain medications such as opioids and NSAIDs are permitted at the discretion of the clinician, provided they were also administered prior to the development of metastases

Client Benefits

The study will cover all diagnostics (bloodwork, x-rays, etc) and treatments (oral drugs) associated with the osteosarcoma while your dog is enrolled in this study as well as the management of any study-related side effects up to a total of $4000. This will cover treatment for approximately 4-6 months; after this point in time, if your dog is doing well and continues on therapy, costs for monitoring (bloodwork, x-rays) will not be covered, although the drugs (Palladia/losartan) will be provided at no cost. Except for the specific financial support described here, any tests or procedures unrelated to this study including treatment of conditions unrelated to the osteosarcoma 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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