Tumor Paint for Solid Tumors—Phase 2
Use of a "tumor paint" a bioconjugate composed of the tumor targeting peptide chlorotoxin (Ctx) conjugated to a near infra-red fluorophore to identify tumor tissue
Purpose of Study
For many types of cancer, surgery is the primary treatment and the surgeon’s ability to remove all of the tumor, and nothing more, is directly related to survival of the patient. Blaze Bioscience, Inc. is developing a drug called Tumor Paint to “paint” a tumor while it is still in the patient. This paint, along with a special imaging device, allows the surgeon to see the tumor so they can completely remove the cancerous tissue while sparing surrounding healthy tissue. This technology will be particularly helpful in human brain, prostate and breast cancers.
The goals of Phase 1 of this study were to determine the binding capability of Tumor Paint to different cancer cells, to assess the Tumor Paint signal in various tumor types and to determine the ideal dose for dogs. 28 dogs were entered into Phase 1 of this study and no serious side effects were noted.
Study goals for Phase 2 are to:
Goal 1: Evaluate the ability to view not only the tumor but the surrounding cancer cells during surgery using an imaging device that can “see” Tumor Paint.
Goal 2: Focus specifically on how Tumor Paint binds to soft tissue sarcomas, mammary tumors, lung tumors and brain tumors.
Information gained from this trial will lead to further human clinical trials, as well as future studies in pets with cancer, paving the way for new cancer treatments for both humans and animals. Enrolled dogs will receive state of the art therapy to remove their solid tumors. Upon study completion owners will receive a $1,000.00 credit towards their pet’s bill.
Enrolled dogs need to have a diagnosed, malignant, solid tumor that can be surgically removed. They must have a life expectancy greater than six weeks and may not have any evidence of metastasis (beyond lymph nodes) or be pregnant or lactating. They will need to spend eight hours at the WSU-VTH on injection day and may be required to have blood samples taken at least three times after the Tumor Paint injection. As surgical removal of the tumor is part of the study, eligible dogs must also be deemed healthy enough to undergo anesthesia and surgery.
Enrolled dogs will be given a physical examination and blood and urine will be collected to make sure they are healthy enough to proceed with the trial. Once they pass the physical exam, participating dogs will receive an injection of Tumor Paint. Blood may be drawn at specific time points after the Tumor Paint injection to see how much Tumor Paint is circulating throughout the bloodstream. Between 24 and 72 hours after injection the dog will be anesthetized and undergo surgery to have their tumor removed. They will need to stay in the VTH intensive care unit for normal, post-surgical monitoring until their surgeon says they are ready to return home.
Owners are responsible for the costs associated with the diagnosis of their dog's cancer as well as surgery and anesthesia costs beyond the money credited by the study. Owners may also responsible for the costs of additional hospitalization, medications and procedures associated with unforeseen complications.
For more information please contact:
Valorie Wiss, Clinical Studies Coordinator
Dr. Janean Fidel