CSU Animal Cancer Center Clinical Trial

Patient Disease:
Canine patients with osteosarcoma of the limb.

Study Name:
Bisphosphonate-targeted chemotherapy to treat osteosarcoma bone pain.

Purpose of the Study:
Osteosarcoma (OSA) is the most common form of bone cancer in dogs and humans. It occurs most often in larger-breed dogs. Osteosarcoma is characterized by aggressive, painful bone destruction and a high rate of spread to other locations in the body (known as “metastasis”). Despite improvements in surgical treatment and chemotherapy, 80% of dogs still will die from this disease. Many older, large-breed dogs may not be candidates for “definitive” treatments, such as amputation, due to co-existing nervous-system or bone diseases, presence of metastasis, owner reluctance, or financial constraints.

New forms of treatment to control OSA pain are desperately needed. Bisphosphonates are a class of bone-targeting drugs capable of inhibiting bone loss and reducing pain associated with bone lesions in patients with cancer. They also may have both direct and indirect antitumor effects in OSA cells. We are working with a company which has developed novel conjugate molecules of bisphosphonate drugs and chemotherapy drugs that can deliver the chemotherapy drug directly to the site of bone disease. Bone-specific drug delivery and enhanced survival has been seen in studies using mouse models of cancer with bone involvement.

This clinical trial will evaluate the ability of one of these bisphosphonate-chemotherapy conjugates to lessen pain and decrease bone loss in canine patients with OSA.

Patient Entry Criteria:
Certain criteria will determine if your pet qualifies for this study. Dogs with osteosarcoma of a leg may be eligible for this study. They may not have received previous treatment for their osteosarcoma. Dogs previously treated with nonsteroidal anti-inflammatory drugs (NSAIDs) or steroids are eligible. A 72-hour withdrawal from treatment with these medications is necessary, with the exception of prior treatment with deracoxib, which can be continued. Dogs with spread of the osteosarcoma to other locations in the body (metastasis) may be eligible. Patients must be in good health and have relatively normal blood work prior to starting this study. Dogs with fractures are not eligible to enroll in the study. 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. The owner is expected to make and keep all appointments according to the study protocol.

Financial Incentives:
Special financial considerations will be given to the clients for their pet’s participation in this study. The study will pay for the screening DEXA bone density evaluation prior to enrollment, study-related blood and urine testing, force-plate gait analysis, follow-up bone-density evaluations and X-rays. In addition, the study will pay for the follow-up examinations and the investigational drug. The study will contribute a $700.00 credit to the owner’s Veterinary Medical Center account for additional therapy, if the investigational drug is not effective in treatment.

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