Neoplasms

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Neoplasms, Connective and Soft Tissue

Neoplasms by Histologic Type

Soft Tissue Sarcoma

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Alkylating Agents

Protein Kinase Inhibitors

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 enlarged solid tumor.

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.

Multiple drug microinjection

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.

CIVO device

Gary Deutsch, MD

Kenneth Gundle, MD

Seth Pollack, MD

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.

Precise Local Injection of Anti-cancer Drugs Using Presage's CIVO Device in Soft Tissue Sarcoma

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.

Analysis will be performed to determine if there is a difference in responses caused by each drug versus the vehicle control

Relationship of AE to study device or study procedure will be determined using an AE Relatedness Grading System.

Analysis will be performed for fraction of cells positive for apoptosis and drug target engagement biomarkers

Spots Global Cancer Trial Database for multiple drug microinjection