Cummings School of Veterinary Medicine

Enhancing osteosarcoma outcomes with a new vaccine platform

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  • Recruiting
  • Dog
  • Oncology

The purpose of this study is to evaluate the use of a new tumor vaccine platform given in combination with chemotherapy in dogs with osteosarcoma, a malignant tumor that affects the long bones in dogs. The standard treatment for dogs with osteosarcoma is amputation of the affected leg followed by 4-6 treatments with a chemotherapy drug, typically either carboplatin or doxorubicin. Unfortunately, 20% of affected dogs will develop spread of the osteosarcoma to the lungs before chemotherapy treatment is completed, and 50% of all dogs will have spread within 6-8 months following amputation. Therefore, new therapies for this cancer are desperately needed. There is increasing evidence that the immune system can recognize and kill osteosarcoma cells and recent studies performed in human cancer patients have shown that personalized tumor vaccines combined with other therapies can significantly improve outcomes in affected patients. In the current study, we will be testing a new approach to stimulating the immune system using a combination of two different immune stimulants given with or without the patient’s own tumor (whole tumor lysate, WTL). The overall goal of this study is to determine whether the immune stimulants alone or the immune stimulants plus the vaccine have the ability to generate an effective anti-osteosarcoma immune response.

Inclusion Criteria

Eligible patients (any breed of dog) must meet all of the following criteria:

  • Diagnosed with histologically or cytologically confirmed osteosarcoma of the appendicular skeleton
  • At least 1 year of age and body weight of 10 kg or higher.
  • No obvious evidence of metastatic disease as assessed by thoracic radiography
  • Adequate organ function as indicated by standard laboratory tests (complete blood count, serum biochemistry profile, urinalysis).
  • Performance status 0 or 1.
  • Otherwise medically healthy with no underlying clinically significant cardiac, renal or hepatic disease.
  • Informed written consent must be obtained

Exclusion Criteria

Patients (dogs) meeting any of the following criteria will not be eligible for the study:

  • Pregnant or lactating dogs
  • Evidence of metastatic disease at presentation
  • Any prior treatment for osteosarcoma
  • Concurrent use of complementary or alternative medicines that in the opinion of the principal investigators would confound the interpretation of toxicities and/or antitumor activity of the study drug.
  • Dogs with significant cardiovascular, renal or hepatic disease.
  • Any serious systemic disorder incompatible with the study (at the discretion of the principal investigators).

Client Benefits

The study will cover $1500 of the approximate $5000-5500 total cost for amputation of the affected leg. The study will also cover costs associated with drug administration, bloodwork, and x-rays for one year (12 months) after amputation. The study will not cover costs associated with complications secondary to amputation (i.e., infection) or doxorubicin chemotherapy, but will cover all costs associated with side effects from vaccination. The study will not cover costs associated with conditions unrelated to the osteosarcoma treatment (skin infection, ear infection, etc.).

Sample or Data Requirements

Your dog will need to have a diagnosis of osteosarcoma based on either a biopsy of the tumor or a needle aspiration of the tumor. Bloodwork and chest x-rays will also need to be performed to make sure that there is no obvious evidence of tumor spread in the lungs and that the liver, kidneys and other body systems are functioning normally. If your dog is enrolled in the study, he/she will undergo amputation of the affected limb followed by a combination of doxorubicin chemotherapy (5 doses) and vaccination with the immune stimulant adjuvant with or without the whole tumor lysate.

The specific details of the procedures and office visits associated with the study are all to be performed at our hospital in Grafton MA and will be provided upon inquiries to the clinical trials office.

Referring Physician Questionnaire

If you believe you have a patient who is eligible for this clinical trial study or you would like additional information from the Clinical Trials Office at the Cummings Veterinary Medical Center, complete a referring physician questionnaire.

Contact

For questions regarding the clinical trial please email clinicaltrials@tufts.edu.