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

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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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.

Conditions
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Soft Tissue Sarcoma Adult

Intervention / Treatment
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* Drug: Multiple drug microinjection
* Device: CIVO device


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 18 years of age or over. At least one suspected soft tissue sarcoma tumor that is considered by the investigator to be: (1) accessible for percutaneous injection and (2) at least 2.5 cm in shortest dimension for patients undergoing an incisional biopsy, or at least 3 cm in shortest dimension for patients undergoing an excisional biopsy/tumor resection. Tumors should not be selected if the Investigator believes them to be necrotic or exhibit signs of radiation-induced fibrosis. Prior surgical evaluation and plan for surgical biopsy or surgery to remove the tumor being injected. ECOG performance status of 0-2 (or a Karnofsky performance status of >50%) Labs required for enrollment (prior to microinjection): Absolute neutrophil count > 1000/mm3 Platelet count > 50,000/mm3 Hematocrit > 25% Creatinine <3.0 mg/dl Total Bilirubin <4.0 mg/dl Bilirubin <4.0 mg/dl, SGOT ≤ 1.5 times the upper limit of normal PT and PTT ≤ 1.5 times the upper limit of normal Exclusion Criteria: Subjects with active fungal, viral, or bacterial infections. Pregnant women. Inability to give informed consent. Current treatment with anticoagulation such as warfarin or low-molecular-weight heparin. Tumors near critical structures such as those located near or in the brain or spine. This assessment will be determined by the treating clinician.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Basic Science
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Multiple drug microinjection<br>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. | Drug: Multiple drug microinjection<br>* 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.<br>* Other names: Saline;Device: CIVO device<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 4-72 hours after microinjection | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | 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 | 4-72 hours after microinjection | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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in vivo drug sensitivity, personalized medicine, precision oncology, in vivo oncology, soft tissue sarcoma, chemotherapy, microinjection, microdosing, tumor microenvironment, multiplexed immunohistochemistry