Clinical Trials /

Implantable Microdevice for the Delivery of Drugs and Their Effect on Tumors in Patients With Metastatic or Recurrent Sarcoma

NCT04199026

Description:

This early phase I trial studies the side effects of implanting and removing a microdevice in patients with sarcomas that have spread to other places in the body (metastatic) or have come back (recurrent). Microdevices are rice-sized devices that are implanted into tumor tissue and are loaded with 10 different drugs that are delivered at very small doses, or "microdoses," which may only affect a very small, local area inside the tumor. The purpose of this study is to determine which drugs delivered in the microdevice affect tumor tissue in patients with sarcomas.

Related Conditions:
  • Sarcoma
Recruiting Status:

Not yet recruiting

Phase:

Early Phase 1

URL:

https://clinicaltrials.gov/show/NCT04199026

Trial Eligibility

Document

Title

  • Brief Title: Implantable Microdevice for the Delivery of Drugs and Their Effect on Tumors in Patients With Metastatic or Recurrent Sarcoma
  • Official Title: Pilot Trial of an Implantable Microdevice for In Vivo Drug Sensitivity Testing in Patients With Sarcomas

Clinical Trial IDs

  • ORG STUDY ID: 2019-0171
  • SECONDARY ID: NCI-2019-05820
  • SECONDARY ID: 2019-0171
  • SECONDARY ID: P30CA016672
  • SECONDARY ID: R01CA180279
  • NCT ID: NCT04199026

Conditions

  • Metastatic Sarcoma
  • Recurrent Sarcoma
  • Resectable Sarcoma

Interventions

DrugSynonymsArms
DoxorubicinAdriablastin, Hydroxydaunomycin, Hydroxyl Daunorubicin, HydroxyldaunorubicinDevice Feasibility (microdevice, surgery)
Doxorubicin Hydrochloride5,12-Naphthacenedione, 10-[(3-amino-2,3,6-trideoxy-alpha-L-lyxo-hexopyranosyl)oxy]-7,8, 9,10-tetrahydro-6,8,11-trihydroxy-8-(hydroxyacetyl)-1-methoxy-, hydrochloride, (8S-cis)- (9CI), ADM, Adriacin, Adriamycin, Adriamycin Hydrochloride, Adriamycin PFS, Adriamycin RDF, ADRIAMYCIN, HYDROCHLORIDE, Adriamycine, Adriblastina, Adriblastine, Adrimedac, Chloridrato de Doxorrubicina, DOX, DOXO-CELL, Doxolem, Doxorubicin HCl, Doxorubicin.HCl, Doxorubin, Farmiblastina, FI 106, FI-106, hydroxydaunorubicin, RubexDevice Feasibility (microdevice, surgery)
Everolimus42-O-(2-Hydroxy)ethyl Rapamycin, Afinitor, Certican, RAD 001, RAD001, Votubia, ZortressDevice Feasibility (microdevice, surgery)
GanitumabAMG 479, Anti-IGF-1R Human Monoclonal Antibody AMG-479Device Feasibility (microdevice, surgery)
IfosfamideAsta Z 4942, Asta Z-4942, Cyfos, Holoxan, Holoxane, Ifex, IFO, IFO-Cell, Ifolem, Ifomida, Ifomide, Ifosfamidum, Ifoxan, IFX, Iphosphamid, Iphosphamide, Iso-Endoxan, Isoendoxan, Isophosphamide, Mitoxana, MJF 9325, MJF-9325, Naxamide, Seromida, Tronoxal, Z 4942, Z-4942Device Feasibility (microdevice, surgery)
IrinotecanDevice Feasibility (microdevice, surgery)
PazopanibGW786034Device Feasibility (microdevice, surgery)
Polyethylene GlycolGlycol, polyethylene, PEG, Poly(oxyethylene), Polyethylene Glycol 400, Polyethylene Glycol 8000, POLYETHYLENE GLYCOL, UNSPECIFIED, Polyethylene OxideDevice Feasibility (microdevice, surgery)
TemozolomideCCRG-81045, Imidazo[5,1-d]-1,2,3,5-tetrazine-8-carboxamide, 3, 4-dihydro-3-methyl-4-oxo-, M & B 39831, M and B 39831, Methazolastone, RP-46161, SCH 52365, Temcad, Temodal, Temodar, Temomedac, TMZDevice Feasibility (microdevice, surgery)
TemsirolimusCCI-779, CCI-779 Rapamycin Analog, Cell Cycle Inhibitor 779, Rapamycin Analog, Rapamycin Analog CCI-779, ToriselDevice Feasibility (microdevice, surgery)
VincristineLEUROCRISTINE, VCR, VincrystineDevice Feasibility (microdevice, surgery)

Purpose

This early phase I trial studies the side effects of implanting and removing a microdevice in patients with sarcomas that have spread to other places in the body (metastatic) or have come back (recurrent). Microdevices are rice-sized devices that are implanted into tumor tissue and are loaded with 10 different drugs that are delivered at very small doses, or "microdoses," which may only affect a very small, local area inside the tumor. The purpose of this study is to determine which drugs delivered in the microdevice affect tumor tissue in patients with sarcomas.

Detailed Description

      PRIMARY OBJECTIVES:

      I. Assess the safety of drug delivery microdevice (microdevice) placement and removal in
      subjects undergoing resection of sarcoma.

      II. Determine the technical feasibility of microdevice placement and removal with intact
      surrounding tissue in subjects undergoing resection of a sarcoma.

      SECONDARY OBJECTIVE:

      I. Use the intratumoral cellular response to evaluate individual agents and/or drug
      combinations released from the microdevice reservoirs to assess the relative drug efficacy
      across all individual agents or drug combinations tested using the microdevice technology.

      EXPLORATORY OBJECTIVES:

      I. Evaluate the microdevice performance for its capacity to predict Response Evaluation
      Criteria in Solid Tumors (RECIST) response in the subset of patients that receive systemic
      chemotherapies as part of their standard-of-care or clinical trial treatments. II. Determine
      genomic, transcriptomic, and proteomic predictive biomarkers from resected specimens that
      correlate with local (i.e. microdevice-based) and systemic drug response. III. Determine, at
      a single-cell level, proteomic traits associated with chemosensitivity versus (vs.)
      resistance using mathematical notions of network robustness and fragility.

      OUTLINE:

      Patients undergo percutaneous implantation of up to 3 drug delivery microdevices up to 2 days
      before standard of care surgery. Patients receive doxorubicin hydrochloride, ifosfamide,
      vincristine, irinotecan, temozolomide, pazopanib, everolimus, polyethylene glycol, ganitumab,
      and temsirolimus via the microdevice in the absence of unacceptable toxicity. At the time of
      surgery 2 days later, patients have the drug delivery microdevice(s) removed. Conditions
      Conditions: Metastatic Sarcoma Recurrent Sarcoma

Trial Arms

NameTypeDescriptionInterventions
Device Feasibility (microdevice, surgery)ExperimentalPatients undergo percutaneous implantation of up to 3 drug delivery microdevices up to 2 days before standard of care surgery. Patients receive doxorubicin hydrochloride, ifosfamide, vincristine, irinotecan, temozolomide, pazopanib, everolimus, polyethylene glycol, ganitumab, and temsirolimus via the microdevice in the absence of unacceptable toxicity. At the time of surgery 2 days later, patients have the drug delivery microdevice(s) removed.
  • Doxorubicin
  • Doxorubicin Hydrochloride
  • Everolimus
  • Ganitumab
  • Ifosfamide
  • Irinotecan
  • Pazopanib
  • Polyethylene Glycol
  • Temozolomide
  • Temsirolimus
  • Vincristine

Eligibility Criteria

        Inclusion:

          -  Patients with a biopsy-confirmed recurrent or metastatic sarcoma for which surgery is
             indicated as a standard of care.

          -  10 years of age or older

          -  Documented, signed, dated informed consent to participate in the microdevice study

          -  ECOG performance status of </= 2

        Exclusion:

          -  Subjects who do not wish to undergo surgical resection, or those who are high-risk or
             not candidates for surgical resection

          -  Age < 10 years old

          -  Women of childbearing potential without a negative pregnancy test; or women who are
             lactating

          -  Allergies or prior adverse drug reactions to any of the drugs loaded within the
             microdevice.
Maximum Eligible Age:N/A
Minimum Eligible Age:10 Years
Eligible Gender:All
Healthy Volunteers:No

Primary Outcome Measures

Measure:Determination of the safety and technical feasibility of microdevice insertion/removal, as assessed by adverse events by CTCAE 5.0.
Time Frame:Up to 1 year
Safety Issue:
Description:Assess the safety of microdevice placement and removal in subjects undergoing resection of sarcoma.

Secondary Outcome Measures

Measure:Determine the drug antineoplastic drug effects observed in the adjacent tumor tissues following exposure to drug micro-doses released by each microdevice reservoir.
Time Frame:Up to 1 year
Safety Issue:
Description:The degree of cell apoptosis and cell proliferation observed in the adjacent tumor tissues will be compared for the placebo control (i.e. PEG) to gauge the antineoplastic effect elicited by each of the drug micro-doses released by the respective microdevice reservoirs.

Details

Phase:Early Phase 1
Primary Purpose:Interventional
Overall Status:Not yet recruiting
Lead Sponsor:M.D. Anderson Cancer Center

Last Updated

March 6, 2020