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

Soft Tissue Sarcoma Adult Clinical Trial

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.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03056599
• Other study ID #: PRS-2
• Status: Completed
• Phase: Phase 1
• Start date: December 15, 2016
• Est. completion date: September 22, 2021

Study information

• Verified date: September 2021
• Source: Presage Biosciences
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 23
• Est. completion date: September 22, 2021
• Est. primary completion date: July 22, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Sarcoma
• Soft Tissue Sarcoma Adult

Intervention

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.

Locations

Country	Name	City	State
United States	Monter Cancer Center (Northwell Health)	Lake Success	New York
United States	OHSU Knight Cancer Institute	Portland	Oregon
United States	Fred Hutchinson Cancer Research Center/Seattle Cancer Care Alliance (SCCA)/University of Washington	Seattle	Washington

Sponsors (5)

Lead Sponsor	Collaborator
Presage Biosciences	Fred Hutchinson Cancer Research Center, Northwell Health, Oregon Health and Science University, University of Washington

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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.	up to 28 days after microinjection
Secondary	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	4-72 hours after microinjection