[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100517333":3},{"organization":4,"armGroups":7,"interventions":14,"overallOfficials":22,"centralContacts":27,"locations":36,"responsibleParty":65,"collaborators":31,"id":68,"slug":31,"hasResults":69,"nctId":70,"briefTitle":71,"officialTitle":72,"acronym":73,"eligibilityCriteria":74,"healthyVolunteers":69,"sex":75,"minAge":76,"maxAge":77,"enrollmentInfo":78,"targetDuration":31,"studyType":81,"phases":82,"briefSummary":84,"conditions":85,"keywords":88,"overallStatus":39,"whyStopped":31,"lastUpdateSubmitDate":94,"lastUpdatePostDateStruct":95,"startDateStruct":98,"completionDateStruct":100,"leadSponsor":102,"locationsCount":103},{"fullName":5,"class":6},"Allegheny Singer Research Institute (also known as Allegheny Health Network Research Institute)","OTHER",[8],{"label":9,"type":10,"description":11,"interventionNames":12},"Treatment Arm - intracavitary tocilizumab","EXPERIMENTAL","Four incremental weekly intra-cavitary doses of tocilizumab starting at 0.5μg\u002FmL and increasing to 1.6μg\u002FmL, 5μg\u002FmL and 50μg\u002FmL once a week over four weeks.",[13],"Drug: Tocilizumab",[15],{"type":16,"name":17,"description":18,"armGroupLabels":19,"otherNames":20},"DRUG","Tocilizumab","Each patient will receive four incremental weekly intra-cavitary doses of tocilizumab starting at 0.5μg\u002FmL and increasing to 1.6μg\u002FmL, 5μg\u002FmL and 50μg\u002FmL once a week over four weeks.",[9],[21],"Actemra",[23],{"name":24,"affiliation":25,"role":26},"Patrick Wagner, MD","Director of Complex General Surgical Oncology","PRINCIPAL_INVESTIGATOR",[28,33],{"name":24,"role":29,"phone":30,"phoneExt":31,"email":32},"CONTACT","412-359-3731",null,"patrick.wagner@ahn.org",{"name":34,"role":29,"phone":30,"phoneExt":31,"email":35},"AHN Clinical Trial Contact","clinicaltrials@ahn.org",[37],{"facility":38,"status":39,"city":40,"state":41,"zip":42,"country":43,"countryCode":44,"cosmosGeoPoint":45,"geoPoint":50,"contacts":51},"Allegheny Health Network Cancer Institute","RECRUITING","Pittsburgh","Pennsylvania","15213","United States","US",{"type":46,"coordinates":47},"Point",[48,49],-79.99589,40.44062,{"lat":49,"lon":48},[52,53,55,56,59,61,63],{"name":24,"role":29,"phone":30,"phoneExt":31,"email":32},{"name":54,"role":29,"phone":30,"phoneExt":31,"email":35},"AHN Clinical Trials Contact",{"name":24,"role":26,"phone":31,"phoneExt":31,"email":31},{"name":57,"role":58,"phone":31,"phoneExt":31,"email":31},"Catherine Lewis, MD, PhD","SUB_INVESTIGATOR",{"name":60,"role":58,"phone":31,"phoneExt":31,"email":31},"Stephanie Baltaji, MD",{"name":62,"role":58,"phone":31,"phoneExt":31,"email":31},"David Bartlett, MD",{"name":64,"role":58,"phone":31,"phoneExt":31,"email":31},"Alexander Shannon, MD",{"type":26,"investigatorFullName":66,"investigatorTitle":67,"investigatorAffiliation":5,"oldNameTitle":31,"oldOrganization":31},"Patrick Wagner, MD, FACS","Investigator","100517333",false,"NCT06016179","Tocilizumab Delivered Via Pleural and Peritoneal Catheters in Patients With Advanced Metastatic Cancer","Phase I Intra-patient Dose Escalation Study of the IL-6 Receptor Antagonist Tocilizumab Delivered Via Pleural and Peritoneal Catheters in Patients With Pleural Effusion or Peritoneal Ascites Due to Metastatic Cancer","RIOT2","Inclusion Criteria:\n\n1. Males or females ages 18-89 years\n2. Female patients must have a negative pregnancy test and agree to use contraception. Female patients receiving tocilizumab should maintain adequate contraceptive measures during and for a minimum of 90 days after the last dose of tocilizumab. Male patients receiving tocilizumab should maintain adequate contraceptive measures during and for a minimum of 60 days after the last dose of tocilizumab.\n3. Biopsy-proven diagnosis of malignancy with cytologic or radiographic evidence of malignant pleural effusion or ascites\n4. Scheduled to undergo standard-of-care pleural or peritoneal drainage catheter placement\n5. ECOG 0-2\n6. Able to read and understand consent in English and provide informed consent\n\nExclusion Criteria:\n\n1. Pediatric patients\n2. Laboratory abnormalities that indicate clinically significant inflammatory process AST\u002FSGOT \\> 2 times the upper limit of normal ALT\u002FSGPT \\> 2 times the upper limit of normal Total bilirubin \\> 2 times the upper limit of normal Creatinine \\> 2.5 mg\u002FdL Hemoglobin \\\u003C 7 mg\u002FdL White blood cell count \\\u003C 3,000\u002F mm3 Platelet count \\\u003C 70,000\u002Fmm3 Absolute neutrophil cell count \\\u003C 2,000 per mm3\n3. ECOG \\> 3\n4. Subjects who are unable to comply with study procedures including travel for weekly outpatient clinic visits\n5. Pregnant and lactating women\n6. Active immunotherapy within 30 days; concurrent chemotherapy or targeted therapy is permitted but for patients with a history of prior immunotherapy, the most recent dose should be \\>30 days prior to the first treatment visit\n7. Investigational drug use within 30 days prior to first treatment dose\n8. History of systemic autoimmune disease (CRS, GCA, PJIA, RA, and SJIA)\n9. Patient with known hypersensitivity to tocilizumab (IL-6)\n10. Active infection\n11. Medical contraindication or history of adverse reaction to acetaminophen or diphenhydramine","ALL","18 Years","89 Years",{"count":79,"type":80},12,"ESTIMATED","INTERVENTIONAL",[83],"PHASE1","The purpose of this study to find out if tocilizumab can be safely infused into chest or abdominal cavities of patients with malignancy ascites (MA) or malignant pleural effusions (MPE). Patients will have a total of 4 doses, one dose administered each week. Each dose will be greater than the previous one.",[86,87],"Malignant Pleural Effusion","Malignant Ascites",[86,87,17,89,90,91,92,93],"IL-6 receptor antagonist","peritoneal cavity","pleural cavity","intraperitoneal","intrapleural","2025-05-19",{"date":96,"type":97},"2025-05-22","ACTUAL",{"date":99,"type":97},"2024-01-30",{"date":101,"type":80},"2027-01",{"name":5,"class":6},1]