[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100286313":3},{"organization":4,"armGroups":7,"interventions":15,"overallOfficials":34,"centralContacts":38,"locations":44,"responsibleParty":62,"collaborators":64,"id":68,"slug":69,"hasResults":70,"nctId":71,"briefTitle":72,"officialTitle":73,"acronym":33,"eligibilityCriteria":74,"healthyVolunteers":70,"sex":75,"minAge":76,"maxAge":33,"enrollmentInfo":77,"targetDuration":33,"studyType":80,"phases":81,"briefSummary":83,"conditions":84,"keywords":33,"overallStatus":47,"whyStopped":33,"lastUpdateSubmitDate":87,"lastUpdatePostDateStruct":88,"startDateStruct":91,"completionDateStruct":93,"leadSponsor":95,"locationsCount":96},{"fullName":5,"class":6},"M.D. Anderson Cancer Center","OTHER",[8],{"label":9,"type":10,"description":11,"interventionNames":12},"Treatment (brentuximab vedotin)","EXPERIMENTAL","Patients receive brentuximab vedotin IV over 30 minutes on day 1. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.",[13,14],"Drug: Brentuximab Vedotin","Other: Laboratory Biomarker Analysis",[16,29],{"type":17,"name":18,"description":19,"armGroupLabels":20,"otherNames":21},"DRUG","Brentuximab Vedotin","Given IV",[9],[22,23,24,25,26,27,28],"ADC SGN-35","Adcetris","Anti-CD30 Antibody-Drug Conjugate SGN-35","Anti-CD30 Monoclonal Antibody-MMAE SGN-35","Anti-CD30 Monoclonal Antibody-Monomethylauristatin E SGN-35","cAC10-vcMMAE","SGN-35",{"type":6,"name":30,"description":31,"armGroupLabels":32,"otherNames":33},"Laboratory Biomarker Analysis","Correlative studies",[9],null,[35],{"name":36,"affiliation":5,"role":37},"Anne S Tsao","PRINCIPAL_INVESTIGATOR",[39],{"name":40,"role":41,"phone":42,"phoneExt":33,"email":43},"Anne S. Tsao","CONTACT","713-792-6363","astsao@mdanderson.org",[45],{"facility":46,"status":47,"city":48,"state":49,"zip":50,"country":51,"countryCode":52,"cosmosGeoPoint":53,"geoPoint":58,"contacts":59},"M D Anderson Cancer Center","RECRUITING","Houston","Texas","77030","United States","US",{"type":54,"coordinates":55},"Point",[56,57],-95.36327,29.76328,{"lat":57,"lon":56},[60,61],{"name":40,"role":41,"phone":42,"phoneExt":33,"email":33},{"name":40,"role":37,"phone":33,"phoneExt":33,"email":33},{"type":63,"investigatorFullName":33,"investigatorTitle":33,"investigatorAffiliation":33,"oldNameTitle":33,"oldOrganization":33},"SPONSOR",[65],{"name":66,"class":67},"National Cancer Institute (NCI)","NIH","100286313","phase-2-brentuximab-vedotin-in-treating-patients-with-cd30-malignant-mesothelioma-that-cannot-be-removed-by-surgery-100286313",false,"NCT03007030","Brentuximab Vedotin in Treating Patients With CD30+ Malignant Mesothelioma That Cannot Be Removed by Surgery","Phase II Trial of Adcetris (Brentuximab Vedotin) in CD30+ Malignant Mesothelioma","Inclusion Criteria:\n\n* Voluntary written informed consent before performance of any study-related procedure not part of normal medical care, with the understanding that consent may be withdrawn by the subject at any time without prejudice to future medical care\n* Female subject is either: a. post-menopausal for at least one year before the screening visit; or b. surgically sterilized; or c. willing to use an acceptable method of birth control (i.e., a hormonal contraceptive, intra-uterine device, diaphragm with spermicide, condom with spermicide, or abstinence) for the duration of the study and at least 6 months after the last dose of brentuximab vedotin\n* Male subject, even if surgically sterilized (i.e., status postvasectomy), agrees to use an acceptable barrier method for contraception (condom with a spermicidal agent), or completely abstain from heterosexual intercourse during the entire study treatment period through 6 months after the last dose of brentuximab vedotin\n* Absolute neutrophil count (ANC) \\> 1500\u002Fmm\\^3\n* Platelets \\> 100,000\u002Fmm\\^3\n* Hemoglobin (Hgb) \\> 8.5 g\u002FdL\n* Total bilirubin =\\\u003C 1.5 x upper limit of normal (ULN)\n* Serum glutamic-oxaloacetic transaminase (SGOT) (aspartate aminotransferase \\[AST\\]) and serum glutamate pyruvate transaminase (SGPT) (alanine aminotransferase \\[ALT\\]) \\\u003C 3 x ULN; AST and\u002For ALT may be up to 5 X ULN if with known liver metastases (mets)\n* Calculated creatinine clearance must be \\>= 30 mL\u002Fminute\n* Eastern Cooperative Oncology Group (ECOG) performance status 0-2\n* Pathologic diagnosis of malignant mesothelioma (any primary site is acceptable, any histology is acceptable)\n* Have unresectable malignant mesothelioma (any histology)\n* Positive CD30+ immunohistochemical expression\n* Any line of prior therapy - patients may be chemo-naive or chemo-refractory (any line)\n* Patients must have measurable disease by modified Response Evaluation Criteria in Solid Tumors (RECIST) or RECIST; examinations for assessment of measurable disease must have been completed within 28 days prior to registration\n\nExclusion Criteria:\n\n* Radiation therapy to more than 25% of the bone marrow; whole pelvic radiation is considered to be over 25%\n* Prior allogeneic bone marrow or organ transplantation\n* Female subject who is pregnant or breast-feeding; confirmation that the subject is not pregnant must be established by a negative serum beta-human chorionic gonadotropin (B-hCG) pregnancy test result obtained during screening; pregnancy testing is not required for post-menopausal or surgically sterilized women\n* Patient has received other investigational drugs with 14 days before enrollment\n* Serious medical or psychiatric illness likely to interfere with participation in this clinical study\n* No prior history of malignancy within 2 years, unless cured of a skin cancer or a stage I-III solid tumor; no prior hematologic malignancy within 3 years\n* Known hypersensitivity to brentuximab vedotin components\n* Persons who are incarcerated at time of enrollment (e.g., prisoners) or likely to become incarcerated during the study","ALL","18 Years",{"count":78,"type":79},55,"ESTIMATED","INTERVENTIONAL",[82],"PHASE2","This phase II trial studies how well brentuximab vedotin works in treating patients with CD30 positive (+) malignant mesothelioma that cannot be removed by surgery. Monoclonal antibodies, such as brentuximab vedotin, may interfere with the ability of tumor cells to grow and spread.",[85,86],"CD30-Positive Neoplastic Cells Present","Malignant Mesothelioma","2026-05-13",{"date":89,"type":90},"2026-05-15","ACTUAL",{"date":92,"type":90},"2017-04-05",{"date":94,"type":79},"2027-05-01",{"name":5,"class":6},1]