SAFETY AND EFFICACY OF TANOVEA™
Study to Determine the Safety and Efficacy of TANOVEA™ (Rabacfosadine for Injection) in Cats with Lymphoma
Craig A Clifford DVM, MS, DACVIM (Oncology), Kristen Kicenuik, DVM, DACVIM (Oncology), Christine Mullin, VMD, Diplomate ACVIM (Oncology), and Rebecca Risbon, VMD, DACVIM (Oncology)
Lymphoma is one of the most common cancers in cats. Chemotherapy is the treatment of choice, and multi-agent doxorubicin-containing protocols are often recommended. Rabacfosadine is a pro-drug of the nucleotide analog 9-(2-phophonylmethoxyethyl) guanine (PMEG) that selectively targets lymphoid cells and inhibits DNA synthesis. Recent studies in normal dogs and dogs with spontaneous lymphoma have demonstrated the safety and efficacy of rabacfosadine when administered according to a variety of dosing regimens. In previous work, rabacfosadine was administered to 4 healthy cats as a single dose at 0.25 mg/kg with no adverse effects.
The primary objective of this study is to determine the maximum tolerated dose, dose-limiting toxicities, safe starting dose, and pharmacodynamic effect of TANOVEA™ (rabacfosadine for injection) in cats with lymphoma. A secondary objective of this study is to assess the efficacy and determine progression-free survival in treated cats.
This is a non-placebo clinical trial, all cats will receive treatment. Treatment is given as an intravenous (IV) injection every 21 days for 5 treatments. Cats will undergo diagnostic testing including bloodwork, urinalysis, thoracic radiographs, needle aspirate or biopsy, possibly abdominal ultrasound prior to enrollment to ensure eligibility. After enrollment cats will undergo diagnostic testing including bloodwork, urinalysis, thoracic radiographs, possibly abdominal ultrasound.
· Age: At least 1 (one) year old
· Diagnosis: Cats must have a diagnosis of low, intermediate or high grade, lymphocytic or lymphoblastic lymphoma, cytologically or histologically confirmed in any anatomic site.
· Prior treatment: Prior surgery, radiotherapy, and/or chemotherapy are acceptable. There must be a two-week washout period between prior chemotherapy and Day 0 and a six-week washout period between radiotherapy and Day 0.
· General health: Cats must be free of severe underlying disease (including underlying pulmonary pathology), FeLV and FIV negative, and have an expected survival of at least 6 weeks. Cats must have adequate organ function as indicated by standard laboratory tests.
· Informed consent: The owner must have provided written, informed consent prior to enrolling in the study.
· Cats that have received chemotherapy within 2 weeks of Day 0.
· Cats that have received non-steroidal anti-inflammatory drugs (NSAIDS) within 72 hours of Day 0 while on the study, treatment with prednisone is acceptable.
· Cats that have received radiation therapy within 6 weeks of Day 0.
· Concurrent malignancy or other serious systemic disorder incompatible with this study.
Sponsor is providing rabacfosadine at no cost to owners
Partial funding is provided to cover some of the costs associated with treatment. Cost of pre-enrollment testing and initial consultation fee are client responsibility.
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