This is a feasibility study in patients with localized or metastatic soft tissue sarcoma undergoing surgery to determine how sarcoma in situ responds to injected microdoses of anti-cancer therapeutics.
This is a single arm, pilot study designed to test the feasibility of using the CIVO (Comparative In Vivo Oncology) system in patients with soft tissue sarcoma accessible for percutaneous injection. Patients who are scheduled for surgical biopsy or tumor resection surgery will be injected 4 to 72 hours prior to surgery using the CIVO device. Minute volumes (up to 8.3 microliters) of saline (negative control) or microdoses of anti-cancer agents will be percutaneously injected in a columnar fashion through each of 8 needles into a single solid tumor. Following the patient's biopsy surgery or tumor resection surgery, the injected portion and a small uninjected portion will be used to determine the in situ drug response in the tumor. None of the data from this evaluation will be shared with patients or used to make clinical decisions. Study clinicians will have access to the patient's health record for 1 year after the study to monitor patient treatment responses. Such information will be used to help evaluate the correlation between clinical response and tumor response assessed via CIVO.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
BASIC_SCIENCE
Masking
NONE
Enrollment
23
This is a feasibility study in patients with localized or metastatic soft tissue sarcoma undergoing surgery to determine how sarcoma in situ responds to injected microdoses of anti-cancer therapeutics.
Feasibility of assessing drug response to precise local injection of anti-cancer drugs using Presage's CIVO device in soft tissue sarcoma patients undergoing surgery.
Monter Cancer Center (Northwell Health)
Lake Success, New York, United States
OHSU Knight Cancer Institute
Portland, Oregon, United States
Fred Hutchinson Cancer Research Center/Seattle Cancer Care Alliance (SCCA)/University of Washington
Seattle, Washington, United States
Quantification of fraction of cells positive for apoptosis and drug target engagement biomarkers around injected drugs
Analysis will be performed to determine if there is a difference in responses caused by each drug versus the vehicle control
Time frame: 4-72 hours after microinjection
Number of patients with adverse events related to pain
Relationship of AE to study device or study procedure will be determined using an AE Relatedness Grading System.
Time frame: up to 28 days after microinjection
Coefficient of variation and intra-class correlation coefficient of fraction of cells around injected drug in multiple tumor planes
Analysis will be performed for fraction of cells positive for apoptosis and drug target engagement biomarkers
Time frame: 4-72 hours after microinjection
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