Now Enrolling Dogs with Invasive Bladder Cancer
Principle Investigator
Description
NC State Medical Oncology is enrolling patients for a clinical trial of an experimental immunotherapy for the treatment of bladder cancer. The primary purpose of this study is to investigate the safety and immune-stimulating properties of a novel therapy being developed at NCSU.
Testing Requirements
8-day study (Monday – Monday) at NC State Veterinary Hospital
• Bladder immunotherapy under general anesthesia, day 1 (Mon)
• Hospitalized for observation, days 1 – 3 (Mon – Wed)
• Return for outpatient evaluation, days 4 (Thurs) and 8 (Mon)
• Multiple blood and urine samples collected over study period
• Quality of life questionnaires collected on days 1 and 8 (Mon, Mon)
Pre-staging, immunotherapy and monitoring provided at no cost
No placebo group – all dogs receive immunotherapy treatment
Re-enrollment for additional immunotherapy doses is possible
Incentives
Staging at no cost ( 1 week prior to treatment):
• CBC, chemistry panel, urinalysis
• Urine culture
• Urine cytology (only if needed)
• Focused urinary tract ultrasound
IL-12 therapy at no cost including:
• Hospitalization
• Anesthesia
• Repeat bloodwork
Enrollment Start
10/21/2023
Enrollment Finish
10/21/2024
Eligibility
Male or female dog, any breed, weighing at least 8 kg (17.6 lbs.)
Urothelial cell carcinoma (UCC; also called transitional cell carcinoma)
• Diagnosis via either cytology and BRAF test; or biopsy/histology
• Muscle-invasive mass in bladder on ultrasound imaging
• Metastatic UCC (e.g., lymph nodes, lungs) is permitted
Patients can be untreated, or have received prior therapy
• One month or more since last radiation or chemotherapy dose
• No other immunotherapy or prednisone treatment allowed
• Non-steroidal anti-inflammatory drugs (NSAIDs) are permitted
Exclusions
Criteria that exclude participation
• Bloodwork abnormalities incompatible with immunotherapy
• Poor quality of life due to cancer (e.g., urinary obstruction)
Flyer
Contact
For additional information please contact the Clinical Studies Core at: cvmclinicalstudies@ncsu.edu or 919-515-3634.
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