CSU Animal Cancer Center Clinical Trial

Patient Disease:
Canine patients with various types of cancer (excluding mast cell tumor, hemangiosarcoma, and malignant histiocytosis).

Study Name:
Liposomal clodronate in canine cancer.

Purpose of the Study:
Macrophages are immune cells that normally scavenge and clear a variety of substances (such as cell debris, bacteria, and foreign materials) from the body. Liposomes are tiny, spherical particles of lipids (a group of compounds that contain fats or oils) that are used to deliver various drugs in the body. Clodronate is a medication in the bisphosphonate class of drugs. Bisphosphonates are used in the treatment of osteoporosis in people and in bone cancer in people and dogs. Previous research found that liposomal clodronate was an effective agent against macrophages. Liposomal clodronate is used to decrease the number of tumor-associated macrophages. The presence of these macrophages in tumors has been associated with increased tumor growth and spread of the cancer (known as  metastasis ). Potentially, liposomal clodronate could be used to treat many different types of tumors. The goals of this study are to demonstrate liposomal clodronate as a safe and effective cancer therapy and to determine the anti-tumor activity of liposomal clodronate against a variety of canine tumors.

Patient Entry Criteria:
In general, these studies are available to qualifying patients living within 100 miles of the Animal Cancer Center at Colorado State University. Dogs with biopsy-confirmed cancers (excluding mast cell tumor, hemangiosarcoma, and malignant histiocytosis) are potentially eligible for this study. The tumor must be less than 8 cm (approximately 3.5 inches) in diameter and located in an easily accessible area for biopsy. Dogs must have good function of liver and kidneys and acceptable blood-cell counts. They must be free of severe underlying disease. Prior treatment is acceptable, with a 72-hour withdrawal from corticosteroids (such as prednisone), a 3-week withdrawal from prior chemotherapy, and a 6-week withdrawal from prior radiation therapy. Owners must consent to a postmortem examination (autopsy) at the time their pet dies or is euthanized.

Owner Responsibilities:
The owner is financially responsible for costs associated with the diagnosis and staging of the disease (such as blood tests, chest X-rays, biopsy) to determine the pet s eligibility for enrollment in this study. In addition, the owner is responsible for the recheck examination fee for each visit during the study and any additional diagnostic tests recommended by the pet s oncology clinician. The owner is expected to make and keep all appointments according to the study protocol.

Financial Incentives:
Once enrolled, the study will pay for the costs of study-related blood work and biopsies and the cost of the liposomal clodronate.

Please contact our Consultation Coordinator at (970) 297-4195 if you are interested in learning more about clinical trials.