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

September 22, 2021 updated by: Presage Biosciences

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.

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

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

Enrollment (Actual)

23

Phase

  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • New York
      • Lake Success, New York, United States, 11042
        • Monter Cancer Center (Northwell Health)
    • Oregon
      • Portland, Oregon, United States, 97239
        • OHSU Knight Cancer Institute
    • Washington
      • Seattle, Washington, United States, 98109
        • Fred Hutchinson Cancer Research Center/Seattle Cancer Care Alliance (SCCA)/University of Washington

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: BASIC_SCIENCE
  • Allocation: NA
  • Interventional Model: SINGLE_GROUP
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: Multiple drug microinjection
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
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.
Other Names:
  • Saline
  • Aldesleukin
  • Gemcitabine
  • Pembrolizumab
  • Doxorubicin
  • Bortezomib
  • Durvalumab
  • Docetaxel
  • Atezolizumab
  • Nivolumab
  • Ipilimumab
  • Eribulin
  • Avelumab
  • Interferon gamma
  • Interferon alfa-2B
  • Trabectedin
  • Olaratumab
  • Larotrectinib
  • Entrectinib
  • Avapritinib
Device: CIVO device
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.

What is the study measuring?

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
Time Frame: 4-72 hours after microinjection
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
Time Frame: up to 28 days after microinjection
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
Time Frame: 4-72 hours after microinjection
Analysis will be performed for fraction of cells positive for apoptosis and drug target engagement biomarkers
4-72 hours after microinjection

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Presage Biosciences

Collaborators

Northwell Health
Oregon Health and Science University
University of Washington
Fred Hutchinson Cancer Center

Investigators

  • Principal Investigator: Gary Deutsch, MD, Northwell Health
  • Principal Investigator: Kenneth Gundle, MD, Oregon Health & Science University (OHSU)
  • Principal Investigator: Seth Pollack, MD, Fred Hutchinson Cancer Research Center/SCCA

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

December 15, 2016

Primary Completion (ACTUAL)

July 22, 2021

Study Completion (ACTUAL)

September 22, 2021

Study Registration Dates

First Submitted

January 22, 2017

First Submitted That Met QC Criteria

February 14, 2017

First Posted (ACTUAL)

February 17, 2017

Study Record Updates

Last Update Posted (ACTUAL)

September 24, 2021

Last Update Submitted That Met QC Criteria

September 22, 2021

Last Verified

September 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • PRS-2

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

Yes

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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