VDC-1101 Succinate for Injection and Prednisone in Canine Lymphoma

Purpose

The goal of this study is to evaluate VDC-1101 when administered to dogs with lymphoma as a single infusion once every 21 days with concurrent low-dose prednisone is being conducted to evaluate the efficacy and safety of this dosage and protocol.

Background

Lymphoma is one of the most common cancers in dogs. Current treatment options include various types of chemotherapy; however, there are no approved drugs for lymphoma in dogs, very few dogs are cured and most will relapse. New drugs remain needed to treat both newly diagnosed lymphoma and drug resistant forms of disease. VDC-1101 is an intravenous chemotherapy agent that has been used both in normal dogs and in more than 80 dogs with cancer. It has been shown to induce remission in 60 to 100% of dogs with lymphoma. The current study seeks to further define the activity and safety of VDC-1101 in dogs with lymphoma when given once every 21 days with concurrent low-dose prednisone. Data from this study will be used to help in the design of the pivotal clinical study protocol with the intent of registering VDC-1101 for use in dogs with lymphoma.

Inclusion Criteria

  • Dogs with confirmed lymphoma
  • Dogs must be at least 1 year old
  • Dogs must weigh over 5.0 kg
  • Dogs with good function of liver and kidneys
  • Dogs with acceptable blood cell counts
  • Dogs free of severe underlying disease

Exclusion Criteria

  • Dogs that have received chemotherapy within 1 week of Day 0.
  • Dogs that have received radiation therapy within 6 weeks of Day 0.
  • Pulmonary fibrosis or a history of chronic pulmonary disease that could lead to fibrosis, such as chronic bronchitis.
  • Concurrent malignancy or other serious systemic disorder incompatible with this study.
  • Dogs that are receiving homeopathic/alternative therapies for their cancer. These should be discontinued on Day -1.
  • Dogs that have received bleomycin
  • West Highland White Terrier dogs, which have a genetic predisposition towards idiopathic pulmonary fibrosis

Study Design

Initially your dog will undergo a series of diagnostic tests, which may include blood tests, urinalysis, a fine needle aspirate of a representative lymph node, and chest x-rays. The results of these initial tests will determine if your dog is eligible to enter this clinical trial. These tests are part of the routine testing done in patients with lymphoma, and may be performed even if you decide that your dog will not participate. Your dog will be sent home with oral prednisone, to be administered every other day. Your dog will then receive an injection of VDC-1101 every 3 weeks for up to 5 treatments. Rechecks will be required 1 week after the first treatment, and possibly 1 week following the second treatment, depending on whether side effects are noted or not. This study is not randomized and there is no placebo group – all dogs will receive VDC‑1101.

Client Compensation

  • Clients participating in will receive VDC-1101 at no cost.

Client Cost

  • Responsible for the costs of the initial examination and tests to insure eligibility to participate, the recheck examinations, chemotherapy administration fee, blood tests, and additional medications.