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Precise Local Injection of Anti-cancer Drugs Using Presage's CIVO™ Device in Soft Tissue Sarcoma

NCT03056599

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.

Related Conditions:
  • Soft Tissue Sarcoma
Recruiting Status:

Recruiting

Phase:

Phase 1

Trial Eligibility

Document

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

DrugSynonymsArms
Multiple drug microinjectionDoxorubicin, Docetaxel, Gemcitabine, Interferon gamma, Pembrolizumab, Ipilimumab, Interferon alfa-2B, Bortezomib, Aldesleukin, Trabectedin, Eribulin, Olaratumab, Atezolizumab, Durvalumab, Avelumab, Nivolumab, SalineMultiple 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 one to three days 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. 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

NameTypeDescriptionInterventions
Multiple drug microinjectionExperimentalPatients who are scheduled for surgical biopsy or tumor resection surgery will be injected one to three days 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:1-3 days 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:1-3 days 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

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