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Soft Tissue Sarcoma AdultPhase 1NCT03056599

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

A Phase 1 study testing Multiple drug microinjection and CIVO device in people with Soft Tissue Sarcoma Adult, run by Presage Biosciences at 3 sites in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Soft Tissue Sarcoma Adult
What is being tested?
Multiple drug microinjection and CIVO device
Could I receive a placebo?
No, everyone receives an active treatment
How many people
23 participants
Where
3 sitesUnited States
Study dates
15 Dec 2016to 22 Sep 2021
Phase
Phase 1
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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
Show all 12Show fewer
  • 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

Who cannot join

  • 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.

Trial locations and contacts

3 sites in 1 country.

United States3 sites

  • Monter Cancer Center (Northwell Health)

    Lake Success, New York, 11042

  • OHSU Knight Cancer Institute

    Portland, Oregon, 97239

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

    Seattle, Washington, 98109

Other trials in United States

About this study

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.

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.

Read the 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.

Being tested
Multiple drug microinjection, CIVO device
Keywords
in vivo drug sensitivity, personalized medicine, precision oncology, in vivo oncology, soft tissue sarcoma, chemotherapy, microinjection, microdosing, tumor microenvironment, multiplexed immunohistochemistry
Medical subject headings
Sarcoma

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Multiple drug microinjectionDrug

    Also called Doxorubicin, Docetaxel, Gemcitabine, Interferon gamma

    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.

  • CIVO deviceDevice

    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 groups in NCT03056599
Study groupRoleWhat they receive
Multiple drug microinjectionExperimentalPatients 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.
Receives: Drug: Multiple drug microinjection; Device: CIVO device

What is being measured

The primary outcome is the main question the study is designed to answer.

  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

    Measured: 4-72 hours after microinjection

Secondary outcomes (2)

  1. 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.

    Measured: up to 28 days after microinjection

  2. 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

    Measured: 4-72 hours after microinjection

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted17 Feb 2017
  2. Study start15 Dec 2016
  3. Primary completion22 Jul 2021
  4. Study completion22 Sep 2021

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 1
Primary purpose
Basic science
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
23 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03056599
Sponsor's protocol ID
PRS-2
Status last verified
Sep 2021
First submitted
22 Jan 2017
Last updated
24 Sep 2021
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
Yes
Individual data sharing
No

Publications

  • 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.

    PubMed 32299817

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing Multiple drug microinjection and CIVO device in people with Soft Tissue Sarcoma Adult, run by Presage Biosciences at 3 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 12 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 24 Sep 2021. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 3 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Quantification of fraction of cells positive for apoptosis and drug target engagement biomarkers around injected drugs (time frame: 4-72 hours after microinjection). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03056599, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Sep 2021.

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