Clinical trial NCT03056599: Precise Local Injection of Anti-cancer Drugs Using Presage's CIVO Device in Soft Tissue Sarcoma
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.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Soft Tissue Sarcoma Adult
Keywords: in vivo drug sensitivity
personalized medicine
precision oncology
in vivo oncology
soft tissue sarcoma
chemotherapy
microinjection
microdosing
tumor microenvironment
multiplexed immunohistochemistry
Lead sponsor: Presage Biosciences
Sponsor class: INDUSTRY
Collaborators: name: Fred Hutchinson Cancer Center
name: University of Washington
name: Northwell Health
name: Oregon Health and Science University
First posted: 2017-02-17
Enrollment: 23
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: BASIC_SCIENCE

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Quantification of fraction of cells positive for apoptosis and drug target engagement biomarkers around injected drugs
timeFrame: 4-72 hours after microinjection
Secondary outcomes:
measure: Number of patients with adverse events related to pain
timeFrame: up to 28 days after microinjection
measure: Coefficient of variation and intra-class correlation coefficient of fraction of cells around injected drug in multiple tumor planes
timeFrame: 4-72 hours after microinjection
Other outcomes:
Locations:
city: Lake Success
country: United States
facility: Monter Cancer Center (Northwell Health)
state: New York
city: Portland
country: United States
facility: OHSU Knight Cancer Institute
state: Oregon
city: Seattle
country: United States
facility: Fred Hutchinson Cancer Research Center/Seattle Cancer Care Alliance (SCCA)/University of Washington
state: Washington
Study officials:
affiliation: Northwell Health
name: Gary Deutsch, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Oregon Health & Science University (OHSU)
name: Kenneth Gundle, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Fred Hutchinson Cancer Research Center/SCCA
name: Seth Pollack, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Gundle KR, Deutsch GB, Goodman HJ, Pollack SM, Thompson MJ, Davis JL, Lee MY, Ramirez DC, Kerwin W, Bertout JA, Grenley MO, Sottero KHW, Beirne E, Frazier J, Dey J, Ellison M, Klinghoffer RA, Maki RG. Multiplexed Evaluation of Microdosed Antineoplastic Agents In Situ in the Tumor Microenvironment of Patients with Soft Tissue Sarcoma. Clin Cancer Res. 2020 Aug 1;26(15):3958-3968. doi: 10.1158/1078-0432.CCR-20-0614. Epub 2020 Apr 16.