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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

23 participants

Study Classification

INTERVENTIONAL

Study Start Date

2016-12-15

Study Completion Date

2021-09-22

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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Soft Tissue Sarcoma Adult

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

NONE

Study Groups

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Multiple drug microinjection

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.

Group Type EXPERIMENTAL

Multiple drug microinjection

Intervention Type 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.

CIVO device

Intervention Type 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.

Interventions

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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.

Intervention Type DRUG

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.

Intervention Type DEVICE

Other Intervention Names

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

Eligibility Criteria

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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.

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No