CSU Animal Cancer Center Clinical Trial

Patient Disease:
Canine patients with malignant melanoma.

Study Name:
NHS-IL2-IL12 in Canine Melanoma

Purpose of the Study:
There are many forms of cancer where standard forms of treatment (surgery, radiation therapy, chemotherapy) are not useful, or stop working after they have been used. 2 novel forms of immunotherapy, NHS-IL12 and NHS-IL2-IL12, are designed to deliver powerful immune-stimulating hormones specifically to tumor tissue. These treatment have shown promise in many mouse models of cancer and in some dogs with melanoma, when delivered directly into tumor tissue.

The goals of the current study are to determine the best dose of NHS-IL12 and NHS-IL2-IL12 to give subcutaneously to dogs with melanoma, and then to determine the anti-tumor effects of these treatments.

Patient Entry Criteria:
Certain criteria determine patient eligibility. Dogs with biopsy-accessible malignant melanoma may be eligible to participate. They must weigh more than 22 poundsPatients must be free of other severe diseases. Dogs must undergo some diagnostic testing prior to starting the study to ensure that they are eligible. They must have good function of liver and kidneys and have acceptable blood cell counts. Previous surgery, chemotherapy, immunotherapy or radiation therapy is allowed; however, a 4-week withdrawal period is required. Concurrent chemotherapy, immunotherapy or radiation therapy is not allowed. Owners must consent to a postmortem examination (autopsy) if their pet dies or is euthanized within 2 weeks of treatment.

Owner Responsibilities:
The owner is financially responsible for costs associated with the diagnosis and staging of the disease (such as blood tests, chest X-rays, biopsy) to determine the pet’s eligibility for enrollment in this study. The owner is expected to make and keep all appointments according to the study protocol.

Financial Incentives:
Clients participating in this study will be given special financial considerations. Specifically, the study will pay for study-related blood work, urinalyses, biopsies, and other diagnostics according to the study protocol for the specific type of cancer, and all costs related to the investigational treatment and follow-up evaluations. The owner is responsible for all other costs relating to care including the cost of diagnosing and staging my pet’s cancer prior to entering the study (approximately $500). Additionally, the cost of treating significant side effects, if they occur, will be defrayed (up to $5000.00).

Please contact our Consultation Coordinator at (970) 297-4195 if you are interested in learning more about clinical trials.