- About the College
- Veterinary Medical Center
- Departments & Offices
All potentially interested veterinarians and owners: PLEASE read the section NOTE TO OWNERS below, concerning the dosing of the drug.
Evaluation of the mTOR Inhibitor Rapamycin in Dogs with Osteosarcoma. A multi-center national trial sponsored by the National Cancer Institute (NCI), Comparative Oncology Program, Comparative Oncology Trials Consortium, and the Morris Animal Foundation
The purpose of this study is to define a relevant dose and dosing schedule for Rapamycin in tumor bearing dogs. This is a dose escalation study (7 days) of Rapamycin in dogs with osteosarcoma (OSA) prior to resection/amputation. Serial pre- and post-treatment tumor biopsies will allow for assessment of tumor biomarkers, which will be correlated with serum biomarkers. After completion of this first phase, future studies will assess the anticancer activity of Rapamycin in dogs with metastatic OSA, alone and in combination with conventional chemotherapy.
Rapamycin has been shown to inhibit mTOR activity, a pathway believed to be important for cancer progression and resistance to therapy. The NCI has shown that mTOR inhibition in human sarcoma cell lines has resulted in suppressed cancer cell proliferations and suppression of the metastatic cell types. Rapamycin is currently approved as an immunosuppressive agent for patients undergoing organ and bone marrow transplants. Its use in dogs has been limited due to their sensitivity to the drug; at higher doses it may cause gastrointestinal problems (potential adverse effects are listed below). However, therapeutic levels of Rapamcyin have been safely achieved in dogs following low-dose administration of the drug.
All potentially interested veterinarians and owners: Please read the section NOTE TO OWNERS below, concerning the dosing of the drug.
Daily administration of Rapamycin needs to be done by intramuscular (IM) injection. This type of injection will be demonstrated to you, but may be difficult for some owners. Administration will likely require two people, one to hold and one to administer the injection. Injection of the drug may sting. Your dog may also be sore at the site of injection, so the sites will need to be rotated daily. Due to the potential difficulty with IM injections, OSU is offering two other alternatives to owners instead of administering the Rapamycin at home. These are:
All visits after the initial visit to establish eligibility will be covered by the study with the exception of surgery. The study will cover $800 to $1000 towards to the surgery but the remainder of the surgical cost would need to be covered by owners. The study will not cover any adjuvant chemotherapy following surgery.
If there are any adverse effects due to Rapamycin, the study will cover the cost of treatment; however, patients must come back to OSU to be treated. Potential effects must be reported with in the 15 day study period.
For more study specifics please contact Dr. William Kisseberth at clinicaltrials [at] cvm [dot] osu [dot] edu.
This study will start enrolling patients on April 2, 2007