Trial for dogs with metastatic apocrine gland anal sac adenocarcinoma
Localized delivery of nanoparticle conjugated cisplatin in dogs with naturally-occurring metastatic apocrine gland anal sac adenocarcinoma.
Purpose and Brief Study Description:
Apocrine gland anal sac adenocarcinoma (AGASACA) is a malignant tumor arising from the secretory epithelium of the walls of the anal sacs. AGASACA displays aggressive biologic behavior and is both locally invasive and highly metastatic, frequently spreading to the lymph nodes early in the course of the disease. Multiple treatment methods have been utilized in the management of AGASACA, including surgery, radiation therapy, chemotherapy, electrochemotherapy, and various combinations thereof. However, there is currently no widely-accepted standard of care therapy for canine AGASACA, other than surgical resection of the primary tumor followed by an adjuvant therapy, such as chemo. One chemotherapeutic agent, cisplatin, is postulated to have potential benefit, but in its naïve form, it has some significant side-effects. Reformulation of cisplatin as a nanoparticle should improve targeting to the primary tumor site and lymph nodes. This then allows for the use of smaller doses of the cisplatin, thereby reducing side-effects while enhancing efficacy.
The primary purpose of this study is to demonstrate the feasibility of localized subcutaneous administration of a nanoparticle formulation of cisplatin, and to demonstrate that this modified formulation accumulates in tumor tissue and local lymph nodes.
Dogs of any breed, age, sex, weighing a minimum of 10kg (22lbs) must be diagnosed cytologically and/or histopathologically with apocrine gland anal sac adenocarcinoma, metastatic to the caudal abdominal lymph nodes. Complete disease staging is required prior to study enrollment, which includes chest x-rays, abdominal ultrasound, blood work, and urinalysis. Prior surgery, chemotherapy, corticosteroids, NSAIDs, and/or radiation therapy is allowable if reoccurrence or progression is documented at the time of study enrollment. Concurrent chemotherapy, corticosteroids, NSAIDs, and/or radiation therapy are not allowable, but post-operative chemotherapy and/or radiation therapy are allowed.
What does enrollment into this trial involve?
All dogs enrolled in this study will receive a single dose of nanoparticle cisplatin chemotherapy administered subcutaneously to the primary tumor and draining lymph nodes. Blood will be collected immediately prior to this dose and then at 0.5, 1, 2, 3, 4, 12, 24, 48, 72 and 96 hours post administration. Surgery will be performed to remove the primary tumor and the local draining lymph nodes on day 5 of the study. Tissues will be submitted for both histopathologic evaluation and pharmacokinetic analysis. The study is completed after study day 21 (or sooner if your dog is removed from the study), and an oncology clinician will discuss additional treatment options with the owner.
The study covers the cost of the nanoparticle conjugated cisplatin, blood work, urinalysis and recheck exam for dogs enrolled. Any adverse events arising as a result of the study drug administration up to $750.00, as well as surgery up to $2000.00 will be covered by the study. Owner is responsible for the costs associated with initial pre-enrollment diagnostic work-up and staging.