Evaluating Effects of a new Bone Tumor Treatment

Purpose

To evaluate the effects of histotripsy, a treatment for that can destroy tissue without radiation or heat, in combination with an immunostimulatory drug, on dogs with osteosarcoma.

Background

In this study, we’re evaluating histotripsy, a new, non-invasive way of treating canine osteosarcoma (OS), on dogs whose owners have decided not to pursue standard cancer treatments like limb amputation surgery, chemotherapy, or radiation. 

Osteosarcoma is the most common primary bone tumor in dogs, and it primarily affects large and giant-breed dogs. Histotripsy has the potential to destroy OS tumors non-invasively and help dogs with OS preserve their limbs. It may also offer some relief from tumor-related pain.

Histotripsy delivers precise, non-thermal focused ultrasound waves that mechanically break apart tumors. In our previous research, we’ve learned that dogs can be safely treated with histotripsy and that histotripsy treatment seems to stimulate the immune system in ways that may help the body fight cancer. In this study, we want to add a new drug to the histotripsy treatment protocol. We hope that, combined with histotripsy, it will stimulate the immune system even more. We also want to evaluate the use of urine samples as a liquid biopsy tool to monitor disease progression in these dogs.

Eligibility

• Confirmed diagnosis or probable diagnosis of appendicular osteosarcoma on forelimb or hindlimb. If OS is suspected via radiographs (x-rays) or other imaging, please contact us.  Cytology/histopathology are not required for referral.
• Absense of lung metastasis confirmed through chest x-rays that have been viewed by a board certified radiologist
• Appropriate tumor volume based on radiographic measurements by the clinical trial team 
  
• Absence of radiographic subchondral bone lysis of affected bone, as determined by the clinical trial team  

Exclusion

• Presence of other life-threatening diseases
• Presence of lung metastasis confirmed on chest x-ray
• Previous local or systemic anti-cancer treatments (radiation therapy, chemotherapy, surgical tumor resection)

Study Design

There are three categories for potential enrollment in this study:

1. Treat and Leave:  To enroll in this category of the study, dogs must have been diagnosed with osteosarcoma based on imaging (e.g. x-rays) and other clinical findings, or by analyzing a sample of the tumor. Dogs whose owners have decided not to pursue standard cancer treatments like amputation surgery, chemotherapy, or radiation, will be enrolled.  Once enrolled, dogs with osteosarcoma will undergo MRI scans and histotripsy treatment of the tumor. Histotripsy is a non-invasive treatment that is delivered through the skin using ultrasound waves. Most patients recover uneventfully and go home the same day. Depending on the size and location of the tumor, more than one treatment may be required.Immediately after the last histotripsy treatment, while the patient is still anesthetized, patients will receive a single injection of an experimental compound called N-dihydrogalactochitosan (GC). This compound is designed to boost the body’s immune system to help it better recognize and fight cancer.Your dog will stay in the study for the rest of his or her life, unless you decide to stop your participation. You may withdraw your dog from the study at any time if you elect to pursue other cancer treatment.
2. Treat and Resect followed by Chemotherapy: Dogs with a diagnosis of osteosarcoma whose owners want to pursue amputation followed by chemotherapy.  These patients will undergo the same initial MRI and histotripsy treatments as well as the immunotherapy injection (GC).  A week after the final histotripsy treatment the amputation will occur at our facility and the amputated limb will be used to further research on the effects of histotripsy on the tumor.   Following amputation the patient will go through a series of chemotherapy treatments with at the Animal Cancer Care and Research Center in Roanoke, Va.
3. Amputation and Chemotherapy Only: Dogs with a diagnosis of osteosarcoma whose owners want to pursue amputation and chemotherapy and either the tumor is deemed not eligible for histotripsy or owners do not wish to puruse histotripsy.  These patients will act as a control group and will undergo the standard of care treatment of amputation followed by chemotherapy.   Follow up chest x-rays will occur at specified intervals to continue to monitor for metastasis.

Compensation

1. Treat and Leave:  The study covers the costs of the MRIs and follow up chest x-rays along with the histotripsy treatment and immunotherapy.  
2. Treat and Resect and Chemotherapy: The study covers the costs of the initial MRI screening, histotripsy, and immunotherapy.  IN addition the study pays $2,000 toward the cost of the sugery or chemotherapy.  
3. Amputation and Chemotherapy only: The study pays $2,000 toward the cost of amputation surgery or chemotherapy as well as follow up chest x-rays.

For treat and resect or amputation patients there is a possibility for financial assistance beyond the $2,000 through a Compassionate Care Fund for cancer patients available at the Animal Cancer Care and Research Center.  Care Credit is also accepted at both the Blacksburg and Roanoke facility.

Contact

• If you'd like to proceed with a study screening appointment, please ask your veterinarian to initiate a referral. Please note that the cost of the screening visit is typically not covered by the study.
• If you'd like to be contacted with more information about this study and/or would like to discuss a case prior to referral, please complete our phone consultation request form.
• If your query is urgent, please call the Animal Cancer Care and Research Center at 540-526-2300.