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Study to Determine the Efficacy and Safety of Alternating Rabacfosadine and Doxorubicin Treatments Against Multicentric Lymphoma in Previously Untreated Dogs

Jun 04, 2019

OBJECTIVE:

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.

ELIGIBILITY REQUIREMENTS:

  • 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)

EXCLUSION CRITERIA:

  • Received chemotherapy
  • 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

OWNER INCENTIVE:

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.

CONTACT:

Amber Tegtmeyer, DVM, Practice Limited to Medical Oncology
Phone: (732)747-3636

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