Working…
COVID-19 is an emerging, rapidly evolving situation.
Get the latest public health information from CDC: https://www.coronavirus.gov.

Get the latest research information from NIH: https://www.nih.gov/coronavirus.
ClinicalTrials.gov
ClinicalTrials.gov Menu
Trial record 1 of 1 for:    CIVO | Soft Tissue Sarcoma
Previous Study | Return to List | Next Study

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03056599
Recruitment Status : Recruiting
First Posted : February 17, 2017
Last Update Posted : February 7, 2020
Sponsor:
Collaborators:
Fred Hutchinson Cancer Research Center
University of Washington
Northwell Health
Oregon Health and Science University
Information provided by (Responsible Party):
Presage Biosciences

Tracking Information
First Submitted Date  ICMJE January 22, 2017
First Posted Date  ICMJE February 17, 2017
Last Update Posted Date February 7, 2020
Actual Study Start Date  ICMJE December 15, 2016
Estimated Primary Completion Date June 30, 2020   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: February 14, 2017)
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
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: February 14, 2017)
  • 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.
  • 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
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Precise Local Injection of Anti-cancer Drugs Using Presage's CIVO™ Device in Soft Tissue Sarcoma
Official Title  ICMJE 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.
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.
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  ICMJE Interventional
Study Phase  ICMJE Phase 1
Study Design  ICMJE Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Basic Science
Condition  ICMJE Soft Tissue Sarcoma Adult
Intervention  ICMJE
  • 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.
Study Arms  ICMJE 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.
Interventions:
  • Drug: Multiple drug microinjection
  • Device: CIVO device
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: March 29, 2019)
24
Original Estimated Enrollment  ICMJE
 (submitted: February 14, 2017)
12
Estimated Study Completion Date  ICMJE June 30, 2020
Estimated Primary Completion Date June 30, 2020   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: Presage Clinical Operations Team 800-530-5404 clinops@presagebio.com
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03056599
Other Study ID Numbers  ICMJE PRS-2
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
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
Product Manufactured in and Exported from the U.S.: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party Presage Biosciences
Study Sponsor  ICMJE Presage Biosciences
Collaborators  ICMJE
  • Fred Hutchinson Cancer Research Center
  • University of Washington
  • Northwell Health
  • Oregon Health and Science University
Investigators  ICMJE
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
PRS Account Presage Biosciences
Verification Date February 2020

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP