Clinical trial · Interventional
Precise Local Injection of Anti-cancer Drugs Using Presage's CIVO Device in Soft Tissue Sarcoma
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.
NCT03056599CI-TRIAL-00054067completedPhase 1ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Soft Tissue Sarcoma Adult | Soft Tissue Sarcoma | ONTOLOGY_EXACT | 0.85 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| CIVO device | Device | — | UNRESOLVED |
| Multiple drug microinjection | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Multiple drug microinjection
- description
- 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.
- interventionNames
- Drug: Multiple drug microinjection
- Device: CIVO device
Primary outcomes (1)
- measure
- Quantification of fraction of cells positive for apoptosis and drug target engagement biomarkers around injected drugs
- timeFrame
- 4-72 hours after microinjection
- description
- Analysis will be performed to determine if there is a difference in responses caused by each drug versus the vehicle control
Secondary outcomes (2)
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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.
References
Publications (1)
- DERIVEDGundle 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. PMID 32299817