CSU Animal Cancer Center Clinical Trial

Patient Disease:
We greatly appreciate your interest and involvement in our clinical trial evaluating a new form of cancer treatment for dogs, using liposomal clodronate.  Your pet’s oncology clinician will explain the disease characteristics of your dog’s type of cancer, as well as available treatment options.  This handout will provide insight into the purpose of this clinical trial and will explain your responsibilities and patient procedures, if you choose to have your pet participate.

Study Name:
Liposomal clodronate in canine cancer.

Purpose of the Study:
Macrophages are immune cells that normally scavenge bacteria and clear a variety of substances (such as cell debris, bacteria, and foreign materials) from the body.  Recent studies suggest that this cell type may actually play an important role in promoting tumor growth and spread (metastasis).  Therefore, we are investigating the effectiveness of a new compound that is designed to eliminate macrophages transiently from the body.  Studies in mice have indicated that treatment with this drug can significantly inhibit tumor growth in mice.  The study will investigate the effectiveness of a bisphosphonate cancer drug (clodronate) that is being administered after being encapsulated within liposomes, which are tiny, spherical particles of lipids 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 for depletion of macrophages.  The goals of this study are to determine whether repeated treatment with liposomal clodronate is both safe and effective as a cancer therapy for dogs with soft tissue sarcoma.

Patient Entry Criteria:
Dogs with biopsy confirmed soft tissue sarcoma of the skin are eligible for this study.  Prior treatment with surgery or radiation therapy is acceptable.  Tumors should not be larger than 12 cm in their longest diameter prior to entry into the study.  Patients with other serious underlying diseases are excluded from the study.  Owners must consent to a postmortem examination (autopsy) at the time their pet dies or is euthanized.

Owner Responsibilities:
You are financially responsible for charges associated with staging tests to determine your pet’s eligibility for enrollment in this study. You are expected to make and keep all appointments according to the study protocol.  You must be committed to completing the entire protocol and follow-up examinations.  Please do not hesitate to obtain additional information from your pet’s oncology clinician if you do not understand something about the study or your pet’s care and treatment.

Financial Incentives:
Clients participating in this study will be given special financial considerations. The study will pay for all costs related to the study blood work and biopsies as well as the liposomal clodronate treatment.  In addition, you will receive financial compensation towards the cost of surgical excision of the tumor if this is what you decide to do following the clinical trial.

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