Study to Determine the Efficacy and Safety of Alternating Rabacfosadine and Doxorubicin Treatments Against Multicentric Lymphoma in Previously Untreated Dogs
Jun 04, 2019
Lymphoma is one of the most common cancers in dogs. Current treatment options include various types of chemotherapy, including TANOVEA®-CA1 (rabacfosadine for injection), the first FDA conditionally approved drug to treat canine lymphoma. It is an intravenous chemotherapy agent that has been used both in normal dogs and in more than 600 dogs with cancer. The goal of this study is to evaluate the effectiveness and safety of rabacfosadine given once every 42 days alternating with doxorubicin given every 42 days.
Patient must be at least 1 year old
Histologic or cytologic diagnosis of lymphomas confirmed
Documentation of immunophenotype
Peripherally accessible and measurable disease
No prior antineoplastic therapy, including corticosteroids
Adequate organ function as indicated by:
Absolute neutrophil count > 2,000 cells/uL; Hematocrit > 25%; Platelet count > 75,000/uL: Serum creatinine <2.5 mg/dL; Bilirubin ≤ the upper normal limit; Transaminases ≤ 3 times the upper normal limit or if > 3 times the upper normal limit then serum bile acids must be ≤ the upper normal limit
General performance score of 0 or 1 on Day 0 (VCOG-CTCAE v1.1)
Received radiation therapy
Received long-acting corticosteroids within 4 weeks, or short acting corticosteroids within 1 week of Day 0
General performance score of > 2 on Day 0.
Pulmonary fibrosis or a history of chronic pulmonary disease that could lead to fibrosis, such as chronic bronchitis
West Highland White Terrier Breed
Concurrent malignancy or other serious systemic disorder which, in the Investigator’s opinion, could results in a life expectancy of less than 3 months.
Pregnant, lactating or intended for breeding.
Any other reason which according to the Investigator, would affect the safety of the dog or severely interfere with study procedures.
Currently enrolled in another clinical study
Owned by an Investigator or his/her staff or family
Any other reason which according to the Investigator, would affect the safety of the dog or interfere with study procedures
Rabacfosadine will be provided at no cost. You will be responsible for the costs of the initial examination and tests to determine eligibility to participate, the recheck examinations, blood tests, and ancillary medications.
Amber Tegtmeyer, DVM, Practice Limited to Medical Oncology