Soft Tissue Sarcoma Adult
Conditions
Keywords
in vivo drug sensitivity, personalized medicine, precision oncology, in vivo oncology, soft tissue sarcoma, chemotherapy, microinjection, microdosing, tumor microenvironment, multiplexed immunohistochemistry
Brief 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.
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.
Interventions
DRUGMultiple 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.
DEVICECIVO 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.
Sponsors
Fred Hutchinson Cancer Center
University of Washington
Northwell Health
Oregon Health and Science University
Presage Biosciences
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
BASIC_SCIENCE
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Quantification of fraction of cells positive for apoptosis and drug target engagement biomarkers around injected drugs | 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 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Number of patients with adverse events related to pain | 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 | 4-72 hours after microinjection | Analysis will be performed for fraction of cells positive for apoptosis and drug target engagement biomarkers |
Countries
United States
Outcome results
None listed