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

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ClinicalTrials.gov Identifier: NCT03056599
Recruitment Status : Recruiting
First Posted : February 17, 2017
Last Update Posted : October 2, 2018
Sponsor:
Collaborators:
Fred Hutchinson Cancer Research Center
University of Washington
Northwell Health
Oregon Health and Science University
Information provided by (Responsible Party):
Presage Biosciences

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Soft Tissue Sarcoma Adult Drug: Multiple drug microinjection Device: CIVO device Phase 1

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 one to three days 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. 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  (Clinical Trial)
Estimated Enrollment : 12 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Basic Science
Official Title: 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.
Actual Study Start Date : December 15, 2016
Estimated Primary Completion Date : December 31, 2019
Estimated Study Completion Date : December 31, 2019

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Multiple drug microinjection
Patients who are scheduled for surgical biopsy or tumor resection surgery will be injected one to three days 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:
  • Doxorubicin
  • Docetaxel
  • Gemcitabine
  • Interferon gamma
  • Pembrolizumab
  • Ipilimumab
  • Interferon alfa-2B
  • Bortezomib
  • Aldesleukin
  • Trabectedin
  • Eribulin
  • Olaratumab
  • Atezolizumab
  • Durvalumab
  • Avelumab
  • Nivolumab
  • Saline

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.




Primary Outcome Measures :
  1. Quantification of fraction of cells positive for apoptosis and drug target engagement biomarkers around injected drugs [ Time Frame: 1-3 days after microinjection ]
    Analysis will be performed to determine if there is a difference in responses caused by each drug versus the vehicle control


Secondary Outcome Measures :
  1. 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.

  2. Coefficient of variation and intra-class correlation coefficient of fraction of cells around injected drug in multiple tumor planes [ Time Frame: 1-3 days after microinjection ]
    Analysis will be performed for fraction of cells positive for apoptosis and drug target engagement biomarkers



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03056599


Contacts
Contact: Presage Clinical Operations Team 800-530-5404 clinops@presagebio.com

Locations
United States, New York
Monter Cancer Center (Northwell Health) Recruiting
Lake Success, New York, United States, 11042
Contact: Sharon Fox         
Principal Investigator: Gary Deutsch, MPH, MD         
Sub-Investigator: Robert Maki, MD, PHD         
Sub-Investigator: Tony Philip, MD         
Sub-Investigator: Mee-young Lee, NP         
Sub-Investigator: Shamsah Lakhani, PA         
Sub-Investigator: Priscila Goncalves, MD         
Sub-Investigator: Eran Ben-Levi, MD         
Sub-Investigator: Daniel Ramirez, MD         
Sub-Investigator: Brian Burke, MD         
Sub-Investigator: Howard Goodman, MD         
United States, Oregon
OHSU Knight Cancer Institute Recruiting
Portland, Oregon, United States, 97239
Contact: Sierra Bertolone-Smith         
Principal Investigator: Kenneth Gundle, MD         
United States, Washington
Fred Hutchinson Cancer Research Center Recruiting
Seattle, Washington, United States, 98109
Contact: Taylor Hain         
Principal Investigator: Seth Pollack, MD         
University of Washington Recruiting
Seattle, Washington, United States, 98195
Contact: Taylor Hain         
Sub-Investigator: Darin Davidson, MD         
Sub-Investigator: Matthew Thompson, MD         
Sponsors and Collaborators
Presage Biosciences
Fred Hutchinson Cancer Research Center
University of Washington
Northwell Health
Oregon Health and Science University
Investigators
Principal Investigator: Seth Pollack, MD Fred Hutchinson Cancer Research Center

Responsible Party: Presage Biosciences
ClinicalTrials.gov Identifier: NCT03056599     History of Changes
Other Study ID Numbers: PRS-2
First Posted: February 17, 2017    Key Record Dates
Last Update Posted: October 2, 2018
Last Verified: September 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: Yes
Device Product Not Approved or Cleared by U.S. FDA: Yes
Pediatric Postmarket Surveillance of a Device Product: No
Product Manufactured in and Exported from the U.S.: No

Keywords provided by Presage Biosciences:
in vivo drug sensitivity
personalized medicine
precision oncology
in vivo oncology
soft tissue sarcoma
chemotherapy
microinjection
microdosing

Additional relevant MeSH terms:
Sarcoma
Neoplasms, Connective and Soft Tissue
Neoplasms by Histologic Type
Neoplasms
Pembrolizumab
Atezolizumab
Interferons
Antineoplastic Agents
Interferon-alpha
Interferon-gamma
Antiviral Agents
Anti-Infective Agents
Immunologic Factors
Physiological Effects of Drugs