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

NCT03056599 | Completed Phase 1 DMC FDA Drug FDA Device

• 1 other identifier: PRS-2
• Study Type: interventional
• Target: 23
• Locations: 1 country
• Sites: 3

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.

Conditions

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

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (2)

• Number of patients with adverse events related to pain

  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

  4-72 hours after microinjection

Study Arms (1)

Multiple drug microinjection

EXPERIMENTAL

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; Device: CIVO device

Interventions

Multiple drug microinjection DRUG

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.

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

Multiple drug microinjection

CIVO device 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.

Multiple drug microinjection

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Presage Biosciences: lead
• Fred Hutchinson Cancer Center: collaborator
• University of Washington: collaborator
• Northwell Health: collaborator
• Oregon Health and Science University: collaborator

Study Sites (3)

Monter Cancer Center (Northwell Health)

Lake Success, New York, 11042, United States

Location

OHSU Knight Cancer Institute

Portland, Oregon, 97239, United States

Location

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

Seattle, Washington, 98109, United States

Location

Related Publications (1)

• 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.

  PMID: 32299817 DERIVED

MeSH Terms

Conditions

Sarcoma

Interventions

Doxorubicin; Docetaxel; Gemcitabine; Interferon-gamma; pembrolizumab; Ipilimumab; Interferon alpha-2; Bortezomib; aldesleukin; Trabectedin; eribulin; olaratumab; atezolizumab; durvalumab; avelumab; Nivolumab; larotrectinib; entrectinib; avapritinib; Sodium Chloride

Condition Hierarchy (Ancestors)

Neoplasms, Connective and Soft Tissue; Neoplasms by Histologic Type; Neoplasms

Intervention Hierarchy (Ancestors)

Daunorubicin; Anthracyclines; Naphthacenes; Polycyclic Aromatic Hydrocarbons; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Polycyclic Compounds; Aminoglycosides; Glycosides; Carbohydrates; Taxoids; Cyclodecanes; Cycloparaffins; Hydrocarbons, Alicyclic; Diterpenes; Terpenes; Heterocyclic Compounds; Deoxycytidine; Cytidine; Pyrimidine Nucleosides; Pyrimidines; Heterocyclic Compounds, 1-Ring; Interferons; Cytokines; Intercellular Signaling Peptides and Proteins; Peptides; Amino Acids, Peptides, and Proteins; Macrophage-Activating Factors; Lymphokines; Proteins; Biological Factors; Antibodies, Monoclonal, Humanized; Antibodies, Monoclonal; Antibodies; Immunoglobulins; Immunoproteins; Blood Proteins; Serum Globulins; Globulins; Interferon-alpha; Interferon Type I; Boronic Acids; Acids, Noncarboxylic; Acids; Inorganic Chemicals; Boron Compounds; Pyrazines; Dioxoles; Tetrahydroisoquinolines; Isoquinolines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Chlorides; Hydrochloric Acid; Chlorine Compounds; Sodium Compounds

Study Officials

• 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

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 22, 2017
• First Posted: February 17, 2017
• Study Start: December 15, 2016
• Primary Completion: July 22, 2021
• Study Completion: September 22, 2021
• Last Updated: September 24, 2021

Record last verified: 2021-09

Data Sharing

• IPD Sharing: Will not share

Locations

US (3)