Clinical Trials Logo

Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT03056599
Other study ID # PRS-2
Secondary ID
Status Completed
Phase Phase 1
First received
Last updated
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
Health authority
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.

Study Design


Related Conditions & MeSH terms


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
See also
  Status Clinical Trial Phase
Active, not recruiting NCT04577014 - Retifanlimab (Anti-PD-1 Antibody) With Gemcitabine and Docetaxel in Patients With Advanced Soft Tissue Sarcoma Phase 1/Phase 2
Recruiting NCT04656262 - Low Dose Continuous Cyclophosphamide vs Standard Doxorubicin in Advanced Sarcoma Elderly Patients Phase 3
Recruiting NCT03077178 - Impact of Locoregional Treatment of Soft Tissue Sarcoma on Status of Patients Aged 70 Years and Over N/A
Not yet recruiting NCT06110650 - A Study of Surufatinib in the Treatment of Advanced Soft Tissue Sarcoma N/A
Terminated NCT03735758 - Quality of Life in Patients With Non-adipocyte Soft Tissue Sarcoma Under Palliative Chemotherapy or Pazopanib Phase 4
Not yet recruiting NCT03951571 - Efficacy and Safety of Anlotinib in Adjuvant Therapy for High-grade Soft Tissue Sarcoma Phase 2
Enrolling by invitation NCT03134742 - Radiation Effects on Bone
Not yet recruiting NCT06252727 - Fluorescent Aided Resection and Evaluation of Soft Tissue Sarcomas (FLARES) Phase 1
Recruiting NCT04617327 - Pre-operative RadiothErapy for Soft Tissue SarcOmas N/A
Recruiting NCT06385288 - Blood and Tissue Extraction for Immunological Examinations During Neoadjuvant Therapy of Soft Tissue Sarcomas N/A
Recruiting NCT05116254 - Sarcomas and DDR-Inhibition; a Combined Modality Study Phase 1
Active, not recruiting NCT03526679 - Lenvatinib and Eribulin in Advanced Soft Tissue Sarcoma Phase 1/Phase 2
Recruiting NCT04008238 - Prospective Identification of Predictive Biomarkers of Trabectedin Efficacy in Non-L Soft-tissue Sarcoma Patients N/A
Recruiting NCT04095208 - Combination of Nivolumab Plus Relatlimab in Patients With Advanced or Metastatic Soft-tissue Sarcoma: a Proof-of-concept Randomized Phase II Study Phase 2
Recruiting NCT04330456 - Combined Treatment of Patients With Soft Tissue Sarcoma Including Preoperative Stereotactic Radiation Therapy and Postoperative Conformal Radiation Therapy N/A
Completed NCT03833037 - Study of a Cohort of Cases of Synovial Sarcoma Treated in the Orthopedic Surgery and Traumatology Department of the Hospital de Sant Pau Between 1983 and 2016
Recruiting NCT05961761 - Propranolol and Pembrolizumab in Advanced Soft Tissue Sarcoma Patients Phase 2
Recruiting NCT06273852 - A Study of the Intratumoral Microdose Administration of PBA-0405 in Patients With Solid Tumors Early Phase 1
Recruiting NCT05182164 - Combination of Pembrolizumab and Cabozantinib in Patients With Advanced Sarcomas Phase 2
Withdrawn NCT03104335 - Apatinib for Advanced Soft Tissue Sarcoma Patients: a Phase 2, Multicenter Trial Phase 2