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

Primary Purpose

Soft Tissue Sarcoma Adult

Status

Completed

Phase

Phase 1

Locations

United States

Study Type

Interventional

Intervention

Multiple drug microinjection

CIVO device

About this trial

This is an interventional basic science trial for Soft Tissue Sarcoma Adult focused on measuring in vivo drug sensitivity, personalized medicine, precision oncology, in vivo oncology, soft tissue sarcoma, chemotherapy, microinjection, microdosing, tumor microenvironment, multiplexed immunohistochemistry

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

Monter Cancer Center (Northwell Health)
OHSU Knight Cancer Institute
Fred Hutchinson Cancer Research Center/Seattle Cancer Care Alliance (SCCA)/University of Washington

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Multiple drug microinjection

Arm Description

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.

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

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.

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

Full Information

NCT ID

NCT03056599

First Posted

January 22, 2017

Last Updated

September 22, 2021

Sponsor

Presage Biosciences

Collaborators

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

1. Study Identification

Unique Protocol Identification Number

NCT03056599

Brief Title

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

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.

Study Type

Interventional

2. Study Status

Record Verification Date

September 2021

Overall Recruitment Status

Completed

Study Start Date

December 15, 2016 (Actual)

Primary Completion Date

July 22, 2021 (Actual)

Study Completion Date

September 22, 2021 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Presage Biosciences

Collaborators

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

4. Oversight

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.

Data Monitoring Committee

Yes

5. Study Description

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 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Soft Tissue Sarcoma Adult

Keywords

in vivo drug sensitivity, personalized medicine, precision oncology, in vivo oncology, soft tissue sarcoma, chemotherapy, microinjection, microdosing, tumor microenvironment, multiplexed immunohistochemistry

7. Study Design

Primary Purpose

Basic Science

Study Phase

Phase 1

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

N/A

Enrollment

23 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Multiple drug microinjection

Arm Type

Experimental

Arm Description

Intervention Type

Drug

Intervention Name(s)

Multiple drug microinjection

Other Intervention Name(s)

Doxorubicin, Docetaxel, Gemcitabine, Interferon gamma, Pembrolizumab, Ipilimumab, Interferon alfa-2B, Bortezomib, Aldesleukin, Trabectedin, Eribulin, Olaratumab, Atezolizumab, Durvalumab, Avelumab, Nivolumab, Larotrectinib, Entrectinib, Avapritinib, Saline

Intervention Description

Intervention Type

Device

Intervention Name(s)

CIVO device

Intervention Description

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 Measure Information:

Title

Quantification of fraction of cells positive for apoptosis and drug target engagement biomarkers around injected drugs

Description

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

Time Frame

4-72 hours after microinjection

Secondary Outcome Measure Information:

Title

Number of patients with adverse events related to pain

Description

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

Time Frame

up to 28 days after microinjection

Title

Coefficient of variation and intra-class correlation coefficient of fraction of cells around injected drug in multiple tumor planes

Description

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

Time Frame

4-72 hours after microinjection

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility 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.

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Gary Deutsch, MD

Organizational Affiliation

Northwell Health

Official's Role

Principal Investigator

First Name & Middle Initial & Last Name & Degree

Kenneth Gundle, MD

Organizational Affiliation

Oregon Health & Science University (OHSU)

Official's Role

Principal Investigator

First Name & Middle Initial & Last Name & Degree

Seth Pollack, MD

Organizational Affiliation

Fred Hutchinson Cancer Research Center/SCCA

Official's Role

Principal Investigator

Facility Information:

Facility Name

Monter Cancer Center (Northwell Health)

City

Lake Success

State/Province

New York

ZIP/Postal Code

11042

Country

United States

Facility Name

OHSU Knight Cancer Institute

City

Portland

State/Province

Oregon

ZIP/Postal Code

97239

Country

United States

Facility Name

Fred Hutchinson Cancer Research Center/Seattle Cancer Care Alliance (SCCA)/University of Washington

City

Seattle

State/Province

Washington

ZIP/Postal Code

98109

Country

United States

12. IPD Sharing Statement

Plan to Share IPD

Citations:

PubMed Identifier

32299817

Citation

Gundle KR, Deutsch GB, Goodman HJ, Pollack SM, Thompson MJ, Davis JL, Lee MY, Ramirez DC, Kerwin W, Bertout JA, Grenley MO, Sottero KHW, Beirne E, Frazier J, Dey J, Ellison M, Klinghoffer RA, Maki RG. Multiplexed Evaluation of Microdosed Antineoplastic Agents In Situ in the Tumor Microenvironment of Patients with Soft Tissue Sarcoma. Clin Cancer Res. 2020 Aug 1;26(15):3958-3968. doi: 10.1158/1078-0432.CCR-20-0614. Epub 2020 Apr 16.

Results Reference

derived

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

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