CSU Animal Cancer Center Clinical Trial

Patient Disease:
Canine patients with B-cell lymphoma.

Study Name:
Canine B-Cell Lymphoma GS 9219 3-arm study.

Purpose of the Study:
Current treatment options available for lymphoma include various combinations of injectable chemotherapy that usually include the drugs doxorubicin, vincristine and cyclophosphamide.  While clinical remission can be induced using chemotherapy, drug resistant relapse is common.  In a previous study in pet dogs with lymphoma treated with GS-9219, we observed dramatic anti-lymphoma activity.  This previous study demonstrated the safety and efficacy of GS-9219 in pet dogs with lymphoma when administered according to a variety of dosing regimens.  However, the optimal dosing regimen has not been conclusively identified.  In the current study, dogs with lymphoma that have come out of remission after chemotherapy treatment will be randomized to 1 of 3 different dosing regimens.  While we know from previous studies in normal laboratory dogs and in client-owned dogs with lymphoma, GS-9219 at the doses to be used in this study is well tolerated.  However, this drug is still investigational and you need to be aware that this drug could cause unknown side-effects.  A small percentage of treated dogs (approximately 5%) have developed pulmonary fibrosis (scarring of the lungs), which can be life-threatening.  We will monitor your dog closely in order to quickly determine if your dog is having problems and treat him/her as they occur.

The purpose of this study is to evaluate 3 different dosing schedules of GS-9219 in dogs with lymphoma.

Patient Entry Criteria:
There are certain criteria to determine if a patient will qualify for this study.  To be eligible, dogs must;

• Have a confirmed diagnosis of B-cell lymphoma.
• Weigh at least 10.0 kg (22 lbs).
• Have received at least one but no more than one prior doxorubicin-based treatment regimen for lymphoma.
• Have relatively normal blood values.
• Not have received chemotherapy within 3 weeks, radiation therapy within 6 weeks, or corticosteroids within 72 hours of starting this study.
• Not have radiographic or clinical evidence of significant pulmonary disease.
• Not have any serious systemic disorder incompatible with this study.
• Discontinue any homeopathic/alternative therapies for their lymphoma.

Owner Responsibilities:
The owner is expected to make and keep all appointments.  The owner is financially responsible for the initial visit and standard staging tests, including blood tests and B cell/T cell testing (if not already performed) prior to entering the study (approximately $200)..  The owner must be committed to making and keeping 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 all costs related to GS-9219 treatment and follow-up evaluations.  Additionally, an $800 Veterinary Medical Center credit will be applied to the owner’s account to defray the costs of alternate treatments. A portion of the $800 alternative treatment fee can be used to offset the initial diagnosis and staging fee. Additionally, the cost of treating significant side-effects from GS-9219, if they were to occur, will be defrayed (up to $5,000).

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