Clinical trials for Oncology specialty
Status: Currently enrolling
This clinical trial led by the National Cancer Institute (NCI) and sponsored by the Morris Animal Foundation seeks to evaluate in dogs with osteosarcoma the safety and effectiveness of Standard of Care therapy, with or without adjuvant rapamycin administration. Standard of Care is defined as definitive surgery, being amputation of the affected limb, followed by 4 doses of intravenous carboplatin chemotherapy given on a q21 day schedule. Carboplatin has been safely and effectively used to treat appendicular osteosarcoma in dogs for > 20 years, but the potential for unforeseen potentially life-threatening side effects from surgery, chemotherapy, and/or progressive cancer does exist. ALL dogs enrolled onto study will receive Standard of Care therapy; however, through a randomization process, some dogs entered into study will also receive additional therapy with oral rapamycin.
Rapamycin is a drug currently approved for immunosuppression during preparatory and maintenance regimens for organ and bone marrow transplant in human patients. Early work with rapamycin suggests that this agent might also have anti-cancer properties by inhibiting (reducing the effects of) an important pathway in cancer progression known as mTOR. Preclinical studies of rapamycin in mice, as well as recent data using analogous drugs in human patients (rapalogs), suggest that mTOR blockade might be effective in the treatment of several cancers. In a recently completed study of rapamycin in dogs with cancer, a dose and schedule for rapamycin administration have been defined which appears to be safe and tolerable by most dogs.
Within this study, dogs will undergo surgical amputation of the affected limb. Dogs will return to Cummings Veterinary Medical Center every 3 weeks for 15 weeks for evaluation. On weeks 3, 6, 9 and 12, dogs will receive treatment carboplatin chemotherapy. After 15 weeks of Standard of Care, based upon initial study randomization, dogs will either receive oral rapamycin on a 4 day on/3 day off schedule for 4 months or will not be treated with any additional medications and simply be monitored every 8 weeks.
- Histologically or cytologically (inclusive of alkaline phosphatase positivity) confirmed osteosarcoma
- Measurable disease that is amenable to surgical removal via amputation (No evidence of metastasis based upon physical exam, chest x-rays, and abdominal ultrasound).
- Favorable performance status: Grade 0 or 1 (modified ECOG [Eastern Cooperative Oncology Group] criteria) - Briefly, Grade 0 means that the animal’s activity level is completely normal; Grade 1 allows for mild lethargy but the animal is still able to perform all “activities of daily living.”
- ONLY newly diagnosed dogs are eligible with no prior therapy (conventional or metronomic chemotherapy, ionizing radiation, bisphosphonates) for osteosarcoma
- Dogs receiving analgesics including NSAIDs, gabapentin, tramadol, or other will be eligible for study inclusion
- Informed owner consent for trial (approved by CSRC/IACUC) - Client’s informed consent includes permission for dogs to undergo full post-mortem examination (necropsy) if the dog dies while on study
- Weight < 25 kg (55 pounds)
- Dogs without measurable disease (appendicular osteosarcoma) at presentation to Tufts
- ANY prior therapy for osteosarcoma (conventional or metronomic chemotherapy, ionizing radiation, bisphosphonates)
- Concurrent medications deemed incongruent with this study; to be determined by NCI COTC investigators.
- Significant co-morbid illness, which includes but is not limited to renal or hepatic failure, history of congestive heart failure or clinical coagulopathy
- Creatinine > 3.0 mg/dL
- Bilirubin > 2.0 mg/dL or elevated bile acids
- HCT < 25%, platelets < 150,000 cells/ul
- Any hematologic/biochemical abnormality > grade 1 ( According to the Veterinary Cooperative Oncology Group – Common Terminology Criteria for Adverse Events [VCOG-CTCAE] v1.1 – which appears in Appendix II in the COTC protocol)
Costs associated with this study (including carboplatin and rapamycin administration and study-related evaluations will be covered by the study. In addition, $1,000 will be provided towards the cost of surgical amputation
For questions regarding the clinical trial, please email the clinical trials technician, Diane Welsh at: firstname.lastname@example.org
Status: Currently enrolling
Bisphosphonates, such as pamidronate and more recently zoledronate, are commonly used for palliation of pain related to malignant osteolysis. Acute systemic inflammatory responses, cardiac arrhythmias, ocular toxicity and significant elevations in pro-inflammatory cytokines have been observed in association with bisphosphonate therapy in humans, although the frequency is uncertain. The primary objective of this study is to investigate if there is an increase in biomarkers of inflammation and myocardial injury after zoledronate administration in dogs with malignant osteolysis. A secondary objective is to assess body temperature and to determine if there is an association between zoledronic acid-induced rise in temperature and elevation in inflammatory biomarkers.
- All dogs must be at least one year old on Day 0.
- All dogs must weigh at least 5kg on Day 0.
- All dogs must have complete baseline cancer staging involving physical exam, chemistry profile and urinalysis prior to enrollment.
- Dogs must have adequate organ function as indicated by standard laboratory tests: hematology (CBC), clinical chemistry and urinalysis.
- All dogs must have either radiographic or advanced imaging to confirm the presence of a lytic bone lesion.
- All dogs must be intended to receive intravenous zoledronate to alleviate associated bone pain as part of their therapeutic plan.
- Dogs that had received prior bisphosphonate (pamidronate or zoledronate) administration.
- Evidence of severe kidney dysfunction.
- Dogs that are receiving corticosteroids for at least 7 days prior to enrollment.
The study will cover the costs associated with one administration of one dose of zoledronate, three CBCs, and the costs of blood tests involved in the study. This amounts to a total financial benefit of approximately $550. The client will be responsible for all other costs associated with the cancer staging (initial consult, chemistry profile, urinalysis, and radiographic or other advanced imaging evidence of a lytic bone lesion) as well as any additional treatments with zoledronate or other cancer therapy during and after completion of the study. Each patient’s participation will allow us to gain information which will help in the side effect management of future dogs undergoing treatment with zoledronate.
Have a case?
Contact Drs. Michele Keyerleber or Molly Holmes at (508) 887-4682, Michele.Keyerleber@tufts.edu or Molly.Holmes@tufts.edu
Status: Currently enrolling
The goal of this study is to measure the presence of a blood marker, miRNA, in dogs with naturally occurring bone cancer (osteosarcoma) and compare these results to healthy unaffected dogs. We hypothesize that the presence of this biomarker will positively correlate with the presence of tumor and high expression levels may be associated with outcomes of disease-free interval and survival time in dogs with osteosarcoma. Approximately 10 mls (2 teaspoons) of blood will be collected from your dog’s vein via routine blood sampling. Blood collection ideally will occur both prior to and following removal of your dog’s tumor. This is a safe amount of blood that can be sampled in any dog greater than 5 kilograms.
Dogs with osteosarcoma weighing 5 kilograms (11 pounds) or greater
Your pet’s participation will allow us to gain information, which will help in the diagnosis/management/treatment of other dogs with this condition. You understand that your animal’s participation in this study may not alleviate or cure his/her ailment.
For questions regarding the clinical trial please email the clinical trials technician, Diane Welsh at: email@example.com