Precise Local Injection of Anti-cancer Drugs Using Presage's CIVO Device in Soft Tissue Sarcoma
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|ClinicalTrials.gov Identifier: NCT03056599|
Recruitment Status : Completed
First Posted : February 17, 2017
Last Update Posted : September 24, 2021
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|Condition or disease||Intervention/treatment||Phase|
|Soft Tissue Sarcoma Adult||Drug: Multiple drug microinjection Device: CIVO device||Phase 1|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||23 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Primary Purpose:||Basic Science|
|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.|
|Actual Study Start Date :||December 15, 2016|
|Actual Primary Completion Date :||July 22, 2021|
|Actual Study Completion Date :||September 22, 2021|
Experimental: 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.
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.
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.
- Quantification of fraction of cells positive for apoptosis and drug target engagement biomarkers around injected drugs [ Time Frame: 4-72 hours after microinjection ]Analysis will be performed to determine if there is a difference in responses caused by each drug versus the vehicle control
- 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: 4-72 hours after microinjection ]Analysis will be performed for fraction of cells positive for apoptosis and drug target engagement biomarkers
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|Ages Eligible for Study:||18 Years and older (Adult, Older Adult)|
|Sexes Eligible for Study:||All|
|Accepts Healthy Volunteers:||No|
- 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
- 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.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03056599
|United States, New York|
|Monter Cancer Center (Northwell Health)|
|Lake Success, New York, United States, 11042|
|United States, Oregon|
|OHSU Knight Cancer Institute|
|Portland, Oregon, United States, 97239|
|United States, Washington|
|Fred Hutchinson Cancer Research Center/Seattle Cancer Care Alliance (SCCA)/University of Washington|
|Seattle, Washington, United States, 98109|
|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|
|Responsible Party:||Presage Biosciences|
|Other Study ID Numbers:||
|First Posted:||February 17, 2017 Key Record Dates|
|Last Update Posted:||September 24, 2021|
|Last Verified:||September 2021|
|Individual Participant Data (IPD) Sharing Statement:|
|Plan to Share IPD:||No|
|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|
in vivo drug sensitivity
in vivo oncology
soft tissue sarcoma
Neoplasms, Connective and Soft Tissue
Neoplasms by Histologic Type
Molecular Mechanisms of Pharmacological Action