Biodynamic Testing of Chemotherapy Sensitivity in Dogs Receiving Gemcitabine for Cutaneous T-cell Lymphoma
Dr. Michael Childress
Epitheliotropic cutaneous T-cell lymphoma (ETCL) in dogs is a skin cancer for which few effective therapies exist. The chemotherapy drug gemcitabine is commonly used to treat humans with this cancer. Although gemcitabine has been shown to be well-tolerated in dogs, its use as a treatment for dogs with ETCL has not been described. In this clinical trial, we will enroll 10 dogs with ETCL to test the efficacy of gemcitabine against this cancer. In addition, we will test the ability of a novel tissue imaging technology, biodynamic imaging (BDI), to predict the responsiveness of ETCL to gemcitabine. We have shown in previous studies BDI predicts the response of primary nodal lymphomas in dogs to chemotherapy with approximately 80-90% accuracy. This will be the first time that BDI is used to predict the response of canine ETCL to a chemotherapy drug. All dogs enrolled in this study will undergo biopsy of one or more skin tumors at the time of trial entry to provide tissue for BDI. All dogs will then receive 6 gemcitabine infusions over a period of 8 weeks while participating in this study.
Eligibility for Dogs to Participate in the Study:
- Histopathologically-confirmed ETCL (tumors diagnosed outside of Purdue must undergo pathology review at the Purdue Animal Disease Diagnostic Laboratory (ADDL) before dogs can be enrolled)
- Dogs with any stage of disease are eligible. However, dogs must have at least 2 grossly apparent ETCL lesions, one of which must be suitable for biopsy to provide tissue for BDI.
- No chemotherapy or radiotherapy in the past 2 weeks. Dogs must not have received any corticosteroids for at least 7 days prior to study enrollment.
- Expected survival of at least 2 months with treatment
- Absence of serious comorbid disease
- Non-epitheliotropic cutaneous T-cell lymphoma or other cutaneous lymphomas
- Disease lesions too limited for biopsy
- Organ dysfunction considered likely to affect tolerability of sedation/biopsy or gemcitabine:
- Hematocrit <25%
- Neutrophils <2,500/ml
- Platelets <50,000/ml
- Creatinine ≥2.1 mg/dl
- Increased bilirubin
- Serum ALT >4X normal without concurrent increase in ALP
- Evidence of hepatic synthetic failure
- Clinically evident coagulopathy
- Serious cardiorespiratory disease
- Prior chemotherapy or radiotherapy within past 14 days
- Prior prednisone or other glucocorticoids within past 7 days
- Body weight <15 kg
- Pet owners will be responsible for $100 towards the cost of initial office visit and clinical evaluation to determine their dog’s eligibility for participation in the study (normal cost approximately $450).
- Pet owners will be responsible for $25 for each gemcitabine treatment given to their dog while it is enrolled in the study, up to a maximum of 6 treatments (normal cost approximately $200 per treatment).
Trial Start Date:
For Questions, Please Call:
Ms. Sarah Lahrman, RVT, or Dr. Michael Childress at (765) 494-1107