Description:
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.
Title
- Brief Title: 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.
Clinical Trial IDs
- ORG STUDY ID:
PRS-2
- NCT ID:
NCT03056599
Conditions
- Soft Tissue Sarcoma Adult
Interventions
| Drug | Synonyms | Arms |
|---|
| Multiple drug microinjection | Doxorubicin, Docetaxel, Gemcitabine, Interferon gamma, Pembrolizumab, Ipilimumab, Interferon alfa-2B, Bortezomib, Aldesleukin, Trabectedin, Eribulin, Olaratumab, Atezolizumab, Durvalumab, Avelumab, Nivolumab, Larotrectinib, Entrectinib, Avapritinib, Saline | Multiple drug microinjection |
Purpose
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.
Trial Arms
| Name | Type | Description | Interventions |
|---|
| Multiple drug microinjection | Experimental | 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. | - Multiple drug microinjection
|
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.
| Maximum Eligible Age: | N/A |
| Minimum Eligible Age: | 18 Years |
| Eligible Gender: | All |
| Healthy Volunteers: | No |
Primary Outcome Measures
| Measure: | Quantification of fraction of cells positive for apoptosis and drug target engagement biomarkers around injected drugs |
| Time Frame: | 4-72 hours after microinjection |
| Safety Issue: | |
| Description: | Analysis will be performed to determine if there is a difference in responses caused by each drug versus the vehicle control |
Secondary Outcome Measures
| Measure: | Number of patients with adverse events related to pain |
| Time Frame: | up to 28 days after microinjection |
| Safety Issue: | |
| Description: | Relationship of AE to study device or study procedure will be determined using an AE Relatedness Grading System. |
| Measure: | 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 |
| Safety Issue: | |
| Description: | Analysis will be performed for fraction of cells positive for apoptosis and drug target engagement biomarkers |
Details
| Phase: | Phase 1 |
| Primary Purpose: | Interventional |
| Overall Status: | Recruiting |
| Lead Sponsor: | Presage Biosciences |
Trial Keywords
- in vivo drug sensitivity
- personalized medicine
- precision oncology
- in vivo oncology
- soft tissue sarcoma
- chemotherapy
- microinjection
- microdosing
- tumor microenvironment
- multiplexed immunohistochemistry
Last Updated
February 12, 2021
