COTC027: Preclinical Comparison of Two Hypomethylating Nucleosides in Tumor-Bearing Dogs

Patient Disease:

Canine Lymphoma or Solid Tumor

Study Name:

Purpose of the study:

To identify a maximally tolerated dose (MTD) of two hypomethylating nucleosides, TdCyd and Aza-TdC, in tumor-bearing dogs. A secondary goal is to evaluate the metabolism of the drugs as well as the effects on the tumor.

Primary Eligibility Criteria:

Weight at least 15 kg (33 lb)
Histologically or cytologically confirmed diagnosis of lymphoma or solid tumor other than mast cell tumor, soft tissue sarcoma, or cutaneous hemangiosarcoma
Adequate blood work
Two-week washout from chemotherapy or radiation therapy, or 7-day washout from steroids or L-asparaginase
Pets must come to CSU for all visits related to the clinical trial

Study Protocol:

Prior to starting treatment, dogs will undergo lymph node aspirates, tumor biopsies, +/- bone marrow aspirate (lymphoma dogs only)
Study drug given orally on Days 1-5 & 8-12; owners responsible for administration at home on Days 2-5 & 9-11
Visits required on Days 1, 8, 12, 15, & 22 for physical exam, tumor measurements, blood work/urinalysis, and study blood collection; at some visits, lymph node aspirates and tumor biopsies +/- bone marrow aspirates will be performed; chest x-rays and abdominal ultrasound will be performed on Day 22
If your dog is responding to treatment at the Day 22 visit, he/she is eligible to stay on the study and continue to receive the study drug for an additional 22 days
Your dog will need to come to the hospital for appointments on days 8, 10, 15, and 22 of this second cycle

Owner Responsibilities:

You are responsible for the initial testing to determine study eligibility and any other tests recommended by your pet’s oncologist
You are expected to make and keep all appointments associated with the study
You must be comfortable administering oral medications to your dog

Financial Incentives:

All costs related to the study are covered, including the chest x-rays and abdominal ultrasound prior to enrollment and during the study, exam fees, blood and urine tests, lymph node aspirates, tumor biopsies, bone marrow aspirates, and the cost of the study drug
$1000 credit given to pet’s account at the VTH at time of study withdrawal to be put towards additional treatments

If you have further questions about any of our clinical trials, please submit an online consult form. Your consult will then be directed to our trials team. Requests are typically returned within 5 business days.