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Feasibility and safety of intra-tumoral carboplatin delivery in canine oral tumors using a novel iontophoretic delivery system

Purpose

To evaluate the safety and feasibility of treating oral tumors in dogs using a novel iontophoretic system to deliver chemotherapy directly to the tumor site.

Background

Canine oral tumors come in many forms and can vary widely in prognosis, depending on tumor location, tumor type, tumor size, and presence of metastatic spread. The two most common cancerous tumor types are malignant melanoma and squamous cell carcinoma. For these cancers, the best outcomes are achieved if surgeons can remove all the tumor with clean margins. Factors such as tumor location, tumor size and invasion of adjacent structures such as bone affect whether or not surgical removal is feasible.  Radiation therapy is recommended after surgery when the tumor is incompletely excised or in some occasions in gross (visible) disease, where surgery is not feasible. Systemic chemotherapy alone hasn’t been effective at treating oral tumors in dogs. Carboplatin is the most common drug used and the one that has shown some efficacy when the disease has spread.  Chemotherapy is usually part of a multimodal treatment protocol; either starting after surgery to address metastatic disease or given concurrently with radiation therapy as a radio-sensitizer.

In this study, we’re testing a medical device that can deliver chemotherapy drugs directly to the tumor. We hope that by delivering treatment straight to the tumor site, we can increase the effectiveness of chemotherapy. This could be important, especially in cases where surgery isn’t a good option. The device used in this study has been used successfully in other cancers, but has never been tried before in dogs with oral cancer.

This study is funded by Focal Medical.

Eligibility

  • Diagnosis of oral malignant melanoma or squamous cell carcinoma
  • Presence of macroscopic (gross) oral mass that is at least 1.5 cm in diameter in all directions
  • Weight at least 33 lbs. (15 kgs)
  • Accessible location of tumor for device placement and smooth and flat location for secure counter electrode placement

Exclusion Criteria

  • Diagnosis of oral tumor other than malignant melanoma or squamous cell carcinoma
  • Presence of life-threatening comorbidities
  • Expected survival < 4 weeks without treatment
  • Previous local or systemic antineoplastic treatments (radiation therapy, chemotherapy, local surgery)

Study Design

This study takes place at the Animal Cancer Care and Research Center (ACCRC) in Roanoke, VA.

This study will enroll dogs diagnosed with either oral malignant melanoma or squamous cell carcinoma, weighing at least 33 lbs./15 kgs, who are otherwise healthy. Dogs will have a screening visit, including a CT scan, paid for by the study. One dog will be enrolled as a control, undergoing systemic chemotherapy, rather than intra-tumoral treatment. The rest of the enrolled dogs will receive intra-tumoral treatment. For all dogs, treatment will take place as quickly as feasible after the screening visit.

The recheck schedule is below, and shows what procedures will be performed at each recheck:

visit schedule

Compensation

The costs of all study-related procedures, including the screening exam and CT scan, the experimental treatment, and all study recheck visits, are covered by the study. If any study-related complications occur, the study will cover the cost of treatment (up to $1,500). If these funds are not used for treating complications, up to $1,500 will be made available as a clinic credit upon completion of the study for any additional therapy the owner wishes to pursue for their dog. Clinic credit must be used at the Animal Cancer Care and Research Center for the enrolled pet.

Initial diagnostic examinations such as biopsy, fine needle aspirates of lymph nodes of the head, chest x-rays or abdominal ultrasound are not covered by the study.

Contact

Dr. Ilektra Athanasiadi, Radiation Oncology 
Phone: 540-526-2300

Mindy Quigley, Clinical Trials Coordinator
Phone: 540-231-1363 | Email: mindyq@vt.edu

If your query is urgent, please call the Animal Cancer Care and Research Center on (540) 526-2300.