ECI-LYM-1 for Dogs with Newly Diagnosed B-Cell Lymphoma
Evaluation of the safety and efficacy of the combination of chemotherapy and ECI-LYM-1 to treat dogs with newly diagnosed B-cell lymphoma
The primary purpose of this study is to demonstrate the safety and efficacy of a combination therapeutic protocol, incorporating chemotherapy and immunotherapy (ECI-LYM-1) which utilizes an autologous tumor vaccine and also infusion of autologous tumor specific T-cells, in dogs with naturally-occurring B-cell lymphoma.
- Dogs 18kgs (40lbs) or larger
- Must have been diagnosed with B-cell lymphoma involving their peripheral lymph nodes that has not been previously treated with radiation therapy and/or chemotherapy, and/or steroids (including prednisone).
- Dogs must be in sufficiently good health (based on the pre-treatment medical history, physical examination, and laboratory analyses) and have no underlying cardiac disease that would preclude the use of doxorubicin.
- Male (either sexually intact or neutered) or female (either sexually intact or neutered) dogs that are not pregnant and not lactating
- Dogs less than 18kg
- Dogs with non-B-cell lymphoma
- Dogs already undergoing treatment for lymphoma or a secondary malignancy.
- Dogs with B-cell lymphoma currently receiving treatments with glucocorticoids or other cytotoxic agents
- Dogs with a secondary malignancy that is not in remission as determined by the clinical investigator.
What does enrollment into this trial involve?
All dogs will undergo lymph node removal, blood sample collection, and bone marrow aspirate (for confirmation of diagnosis and vaccine development) and three doses of doxorubicin chemotherapy for treatment of their lymphoma. Two weeks following the final doxorubicin treatment, a course of three vaccinations will be administered at weekly intervals. At the time of the last vaccination, a skin test will be performed to assess the immune response to the vaccine which will require 2 nights of hospitalization. Apheresis will be performed to extract tumor-specific T lymphocytes from the blood one week after the final vaccination. Your dog will remain hospitalized for two nights following this procedure and receive an additional skin test to assess their immune response to the vaccine. Low-dose, oral chemotherapy (cyclophosphamide) will be administered over 3 days at home in the week following apheresis. The T-cells extracted during apheresis will be expanded at ELIAS Animal Health and will be re-infused 1 week after apheresis. Low-dose IL-2 will be administered, starting 24 hours after the T cell infusion, and will continue for 5 total injections under the skin on an every other day basis. A post treatment follow up visit will occur on day 93.
Once informed consent is obtained and preliminary diagnosis and staging is performed, this trial provides full funding for all treatment-related costs including surgery and all subsequent re-evaluations while on trial, all necessary diagnostics (bloodwork, radiographs), treatment, vaccine administration, apheresis, T-cell infusion, and management of adverse events that are possibly attributed to therapy. The owner is responsible for the costs associated with the initial oncology consultation, lymph node aspirate, and diagnostic flow cytometry to confirm diagnosis.
For more information please contact Misty Bear, Clinical Trials Coordinator:
Phone: (785)532-3046, email:ClinicalTrials@vet.k-state.edu