[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100377783":3},{"organization":4,"armGroups":7,"interventions":26,"overallOfficials":179,"centralContacts":183,"locations":189,"responsibleParty":208,"collaborators":210,"id":214,"slug":215,"hasResults":216,"nctId":217,"briefTitle":218,"officialTitle":219,"acronym":124,"eligibilityCriteria":220,"healthyVolunteers":216,"sex":221,"minAge":222,"maxAge":124,"enrollmentInfo":223,"targetDuration":124,"studyType":226,"phases":227,"briefSummary":229,"conditions":230,"keywords":124,"overallStatus":192,"whyStopped":124,"lastUpdateSubmitDate":234,"lastUpdatePostDateStruct":235,"startDateStruct":238,"completionDateStruct":240,"leadSponsor":242,"locationsCount":243},{"fullName":5,"class":6},"M.D. Anderson Cancer Center","OTHER",[8],{"label":9,"type":10,"description":11,"interventionNames":12},"Device Feasibility (microdevice, surgery)","EXPERIMENTAL","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.",[13,14,15,16,17,18,19,20,21,22,23,24,25],"Drug: Doxorubicin","Drug: Doxorubicin Hydrochloride","Device: Drug Delivery Microdevice","Drug: Everolimus","Biological: Ganitumab","Drug: Ifosfamide","Drug: Irinotecan","Drug: Pazopanib","Drug: Polyethylene Glycol","Drug: Temozolomide","Drug: Temsirolimus","Procedure: Therapeutic Conventional Surgery","Drug: Vincristine",[27,37,65,72,83,90,121,125,130,141,157,167,172],{"type":28,"name":29,"description":30,"armGroupLabels":31,"otherNames":32},"DRUG","Doxorubicin","Given via microdevice",[9],[33,34,35,36],"Adriablastin","Hydroxydaunomycin","Hydroxyl Daunorubicin","Hydroxyldaunorubicin",{"type":28,"name":38,"description":30,"armGroupLabels":39,"otherNames":40},"Doxorubicin Hydrochloride",[9],[41,42,43,44,45,46,47,48,49,50,51,52,53,54,55,56,57,58,59,60,61,62,63,64],"5,12-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","Rubex",{"type":66,"name":67,"description":68,"armGroupLabels":69,"otherNames":70},"DEVICE","Drug Delivery Microdevice","Undergo percutaneous implantation of drug delivery microdevice",[9],[71],"Microdevice",{"type":28,"name":73,"description":30,"armGroupLabels":74,"otherNames":75},"Everolimus",[9],[76,77,78,79,80,81,82],"42-O-(2-Hydroxy)ethyl Rapamycin","Afinitor","Certican","RAD 001","RAD001","Votubia","Zortress",{"type":84,"name":85,"description":30,"armGroupLabels":86,"otherNames":87},"BIOLOGICAL","Ganitumab",[9],[88,89],"AMG 479","Anti-IGF-1R Human Monoclonal Antibody AMG-479",{"type":28,"name":91,"description":30,"armGroupLabels":92,"otherNames":93},"Ifosfamide",[9],[94,95,96,97,98,99,100,101,102,103,104,105,106,107,108,109,110,111,112,113,114,115,116,117,118,119,120],"Asta 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-4942",{"type":28,"name":122,"description":30,"armGroupLabels":123,"otherNames":124},"Irinotecan",[9],null,{"type":28,"name":126,"description":30,"armGroupLabels":127,"otherNames":128},"Pazopanib",[9],[129],"GW786034",{"type":28,"name":131,"description":30,"armGroupLabels":132,"otherNames":133},"Polyethylene Glycol",[9],[134,135,136,137,138,139,140],"Glycol, polyethylene","PEG","Poly(oxyethylene)","Polyethylene Glycol 400","Polyethylene Glycol 8000","POLYETHYLENE GLYCOL, UNSPECIFIED","Polyethylene Oxide",{"type":28,"name":142,"description":30,"armGroupLabels":143,"otherNames":144},"Temozolomide",[9],[145,146,147,148,149,150,151,152,153,154,155,156],"CCRG-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","TMZ",{"type":28,"name":158,"description":30,"armGroupLabels":159,"otherNames":160},"Temsirolimus",[9],[161,162,163,164,165,166],"CCI-779","CCI-779 Rapamycin Analog","Cell Cycle Inhibitor 779","Rapamycin Analog","Rapamycin Analog CCI-779","Torisel",{"type":168,"name":169,"description":170,"armGroupLabels":171,"otherNames":124},"PROCEDURE","Therapeutic Conventional Surgery","Undergo standard of care surgery",[9],{"type":28,"name":173,"description":30,"armGroupLabels":174,"otherNames":175},"Vincristine",[9],[176,177,178],"LEUROCRISTINE","VCR","Vincrystine",[180],{"name":181,"affiliation":5,"role":182},"Joseph Ludwig, MD","PRINCIPAL_INVESTIGATOR",[184],{"name":185,"role":186,"phone":187,"phoneExt":124,"email":188},"Joseph A Ludwig, MD","CONTACT","713-792-3626","jaludwig@mdanderson.org",[190],{"facility":191,"status":192,"city":193,"state":194,"zip":195,"country":196,"countryCode":197,"cosmosGeoPoint":198,"geoPoint":203,"contacts":204},"M D Anderson Cancer Center","RECRUITING","Houston","Texas","77030","United States","US",{"type":199,"coordinates":200},"Point",[201,202],-95.36327,29.76328,{"lat":202,"lon":201},[205,207],{"name":206,"role":186,"phone":187,"phoneExt":124,"email":188},"Joseph A. Ludwig",{"name":206,"role":182,"phone":124,"phoneExt":124,"email":124},{"type":209,"investigatorFullName":124,"investigatorTitle":124,"investigatorAffiliation":124,"oldNameTitle":124,"oldOrganization":124},"SPONSOR",[211],{"name":212,"class":213},"National Cancer Institute (NCI)","NIH","100377783","implantable-microdevice-for-the-delivery-of-drugs-and-their-effect-on-tumors-in-patients-with-metastatic-or-recurrent-sarcoma-100377783",false,"NCT04199026","Implantable Microdevice for the Delivery of Drugs and Their Effect on Tumors in Patients With Metastatic or Recurrent Sarcoma","Pilot Trial of an Implantable Microdevice for In Vivo Drug Sensitivity Testing in Patients With Sarcomas","Inclusion:\n\n* Patients with a biopsy-confirmed recurrent or metastatic sarcoma for which surgery is indicated as a standard of care.\n* 10 years of age or older\n* Documented, signed, dated informed consent to participate in the microdevice study\n* Eastern Cooperative Oncology Group (ECOG) performance status of =\\\u003C 2\n\nExclusion:\n\n* Subjects who do not wish to undergo surgical resection, or those who are high-risk or not candidates for surgical resection\n* Age \\\u003C 10 years old\n* Women of childbearing potential without a negative pregnancy test; or women who are lactating\n* Allergies or prior adverse drug reactions to any of the drugs loaded within the microdevice.","ALL","10 Years",{"count":224,"type":225},20,"ESTIMATED","INTERVENTIONAL",[228],"NA","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.",[231,232,233],"Metastatic Sarcoma","Recurrent Sarcoma","Resectable Sarcoma","2026-02-17",{"date":236,"type":237},"2026-02-19","ACTUAL",{"date":239,"type":237},"2025-02-25",{"date":241,"type":225},"2028-12-31",{"name":5,"class":6},1]