Protocol for the Combined Use of TANOVEA™-CA1 (Rabacfosadine for Injection) and Asparaginase in Dogs with Relapsed Lymphoma

Study Objective: 
TANOVEA™-CA1 (rabacfosadine for injection) has significant activity against both naïve and relapsed canine lymphoma; however, response rates are lower in relapsed dogs that have been previously treated with other cytotoxic drugs, and the number of prior treatments has been shown to correlate with outcome. Asparaginase is a commonly used antineoplastic drug that can potentiate the activity of other anti-lymphoma therapies and has non-overlapping toxicities. This study will evaluate the safety and efficacy of a combined asparaginase and rabacfosadine regimen when used in dogs with lymphoma that have relapsed following treatment with a doxorubicin-based chemotherapy protocol.
Eligibility Requirements: 
  •  At least 1 year old on Day 0.
  • At least 5.0 kg on Day 0.
  • Histologic or cytologic diagnosis of lymphoma with immunophenotype available
  • Relapsed following at least 1 prior doxorubicin-based chemotherapy regimen
  • Adequate organ function: ANC >2,01500 cells/μl; hematocrit >25%; platelets > 5075,000/μl; creatinine <2.5 mg/dl; bilirubin ≤ the upper normal limit; ALT≤ 3 X upper normal limit or if > 3 X upper normal limit serum bile acids must be ≤ the upper normal limit.
  • Performance status of either 0 or 1 on Day 0, according to the modified ECOG Performance Scheme (Veterinary and Comparative Oncology, 2011).
  •  Signed Owner Informed Consent. 
Exclusion Criteria: 
  • Received chemotherapy within 1 week of Day 0.
  • Previous pulmonary pathology that may predispose to fibrosis.
  • Concurrent malignancy or other serious systemic disorder incompatible with this study.
  • Patient is on homeopathic/alternative therapies within 1 day of Day 0. Supplements such as chondroitin sulphate, vitamins, essential fatty acids and glucosamine are permitted.
  • Received bleomycin.
  • West Highland White Terrier Breed
Compensation: 
This is a partially funded trial, the rabacfosadine will be provided at no cost to the client. The client will be responsible for all other costs.
Location of Trial: 
Norwalk, CT

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