[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100520544":3},{"organization":4,"armGroups":7,"interventions":19,"overallOfficials":31,"centralContacts":35,"locations":43,"responsibleParty":127,"collaborators":25,"id":129,"slug":130,"hasResults":131,"nctId":132,"briefTitle":133,"officialTitle":134,"acronym":25,"eligibilityCriteria":135,"healthyVolunteers":131,"sex":136,"minAge":25,"maxAge":25,"enrollmentInfo":137,"targetDuration":25,"studyType":140,"phases":141,"briefSummary":143,"conditions":144,"keywords":148,"overallStatus":46,"whyStopped":25,"lastUpdateSubmitDate":151,"lastUpdatePostDateStruct":152,"startDateStruct":155,"completionDateStruct":157,"leadSponsor":159,"locationsCount":160},{"fullName":5,"class":6},"Memorial Sloan Kettering Cancer Center","OTHER",[8,15],{"label":9,"type":10,"description":11,"interventionNames":12},"Group 1","EXPERIMENTAL","Participants will receive oral β-glucan (40 mg\u002Fkg\u002Fday) for 14 days on, and 14 days off, beginning with vaccination #1 and continuing until vaccination #5 (\\~20 weeks), then only one 14-day cycle with each of vaccinations #6-#10.",[13,14],"Biological: OPT-821 (QS-21)","Dietary Supplement: oral β-glucan",{"label":16,"type":10,"description":17,"interventionNames":18},"Group 2","Participants will receive oral β-glucan (40 mg\u002Fkg\u002Fday) for 14 days on, and 14 days off, beginning with vaccination #1 and continuing until vaccination #7 (\\~52 weeks), then only one 14-day cycle with each of vaccinations #8-#10.",[13,14],[20,26],{"type":21,"name":22,"description":23,"armGroupLabels":24,"otherNames":25},"BIOLOGICAL","OPT-821 (QS-21)","Comprised of the immunological adjuvant OPT-821 (QS-21)",[9,16],null,{"type":27,"name":28,"description":29,"armGroupLabels":30,"otherNames":25},"DIETARY_SUPPLEMENT","oral β-glucan","Participants will be randomized to receive this agent in two different schedules",[9,16],[32],{"name":33,"affiliation":5,"role":34},"Brian Kushner, MD","PRINCIPAL_INVESTIGATOR",[36,40],{"name":33,"role":37,"phone":38,"phoneExt":25,"email":39},"CONTACT","1-833-MSK-KIDS","kushnerb@MSKCC.ORG",{"name":41,"role":37,"phone":38,"phoneExt":25,"email":42},"Fiorella Iglasias Cardenas, MD, MS","iglesiaf@mskcc.org",[44,61,72,83,95,106,116],{"facility":45,"status":46,"city":47,"state":48,"zip":49,"country":50,"countryCode":51,"cosmosGeoPoint":52,"geoPoint":57,"contacts":58},"Memorial Sloan Kettering at Basking Ridge (Consent only)","RECRUITING","Basking Ridge","New Jersey","07920","United States","US",{"type":53,"coordinates":54},"Point",[55,56],-74.54932,40.70621,{"lat":56,"lon":55},[59],{"name":33,"role":37,"phone":60,"phoneExt":25,"email":25},"833-675-5491",{"facility":62,"status":46,"city":63,"state":48,"zip":64,"country":50,"countryCode":51,"cosmosGeoPoint":65,"geoPoint":69,"contacts":70},"Memorial Sloan Kettering Monmouth (Consent Only)","Middletown","07748",{"type":53,"coordinates":66},[67,68],-74.11709,40.39428,{"lat":68,"lon":67},[71],{"name":33,"role":37,"phone":60,"phoneExt":25,"email":25},{"facility":73,"status":46,"city":74,"state":48,"zip":75,"country":50,"countryCode":51,"cosmosGeoPoint":76,"geoPoint":80,"contacts":81},"Memorial Sloan Kettering Bergen (Consent Only)","Montvale","07645",{"type":53,"coordinates":77},[78,79],-74.02292,41.04676,{"lat":79,"lon":78},[82],{"name":33,"role":37,"phone":60,"phoneExt":25,"email":25},{"facility":84,"status":46,"city":85,"state":86,"zip":87,"country":50,"countryCode":51,"cosmosGeoPoint":88,"geoPoint":92,"contacts":93},"Memorial Sloan Kettering Suffolk-Commack (Consent only)","Commack","New York","11725",{"type":53,"coordinates":89},[90,91],-73.29289,40.84288,{"lat":91,"lon":90},[94],{"name":33,"role":37,"phone":60,"phoneExt":25,"email":25},{"facility":96,"status":46,"city":97,"state":86,"zip":98,"country":50,"countryCode":51,"cosmosGeoPoint":99,"geoPoint":103,"contacts":104},"Memorial Sloan Kettering Westchester (Consent only)","Harrison","10604",{"type":53,"coordinates":100},[101,102],-73.71263,40.96899,{"lat":102,"lon":101},[105],{"name":33,"role":37,"phone":60,"phoneExt":25,"email":25},{"facility":107,"status":46,"city":86,"state":86,"zip":108,"country":50,"countryCode":51,"cosmosGeoPoint":109,"geoPoint":113,"contacts":114},"Memorial Sloan Kettering Cancer Center (All Protocol Activities)","10065",{"type":53,"coordinates":110},[111,112],-74.00597,40.71427,{"lat":112,"lon":111},[115],{"name":33,"role":37,"phone":60,"phoneExt":25,"email":25},{"facility":117,"status":46,"city":118,"state":86,"zip":119,"country":50,"countryCode":51,"cosmosGeoPoint":120,"geoPoint":124,"contacts":125},"Memorial Sloan Kettering Nassau (Consent Only)","Uniondale","11553",{"type":53,"coordinates":121},[122,123],-73.59291,40.70038,{"lat":123,"lon":122},[126],{"name":33,"role":37,"phone":60,"phoneExt":25,"email":25},{"type":128,"investigatorFullName":25,"investigatorTitle":25,"investigatorAffiliation":25,"oldNameTitle":25,"oldOrganization":25},"SPONSOR","100520544","phase-2-a-study-of-a-vaccine-in-combination-with-beta-glucan-in-people-with-neuroblastoma-100520544",false,"NCT06057948","A Study of a Vaccine in Combination With Beta-glucan in People With Neuroblastoma","Phase II Trial of a Bivalent Vaccine With the Immunological Adjuvant OPT-821 (QS-21), in Combination With Randomization of Oral β-glucan, for High-Risk Neuroblastoma","Inclusion Criteria:\n\n* Diagnosis of NB as defined by international criteria,102 i.e., histopathology (confirmed by the MSK Department of Pathology) or BM metastases plus high urine catecholamine levels, or positivity in MIBG scan.\n* HR-NB as defined by risk-related treatment guidelines and international criteria,102 i.e., metastatic\u002Fnon-localized disease with MYCN amplification (any age), metastatic disease \\>18 months old, MYCN-amplified localized disease (any age), or disease resistant to standard chemotherapy.\n* HR-NB (as defined above) and in 1) first CR at ≥ 6 months from initiation of immunotherapy using anti-GD2 antibody, or 2) second or subsequent CR (achieved after treatment for PD). CR is defined according to the International Neuroblastoma Response Criteria. Patients with positive MIBG scan but negative FDG-PET scan, and CR in BM, are eligible.\n* Patients with grade 3 toxicities or less using the Common Toxicity Criteria (Version 5.0) developed by the National Cancer Institute of the USA (CTCAE v5.0) related to hematologic, cardiac, neurological, pulmonary, renal, hepatic or gastrointestinal function as determined by blood tests or physical exam. Plus:\n\n  * Absolute neutrophil count (ANC) ≥ 500\u002Fmcl\n  * Absolute lymphocyte count ≥ 500\u002Fmcl\n* \\>21 and \\\u003C180 days between completion of systemic therapy and 1st vaccination.\n* A negative pregnancy test is required for patients with child-bearing capability\n* Signed informed consent indicating awareness of the investigational nature of this program.\n\nExclusion Criteria:\n\n* Patients with grade 4 hematologic, cardiac, neurological, pulmonary, renal, hepatic or gastrointestinal function as determined by blood tests or physical exam, using the Common Toxicity Criteria (Version 5.0) developed by the National Cancer Institute of the USA.\n* History of allergy to KLH, QS-21, OPT-821, or glucan\n* Prior treatment with this vaccine.\n* Active life-threatening infection requiring systemic therapy.\n* Inability to comply with protocol requirements.","ALL",{"count":138,"type":139},94,"ESTIMATED","INTERVENTIONAL",[142],"PHASE2","The purpose of this study is to test which treatment schedule of β-glucan with bivalent vaccine is more effective for participants with high-risk neuroblastoma that is in complete remission.",[145,146,147],"Neuroblastoma","High-risk Neuroblastoma","Metastatic Neuroblastoma",[145,146,147,149,5,150],"HR-NB","23-198","2026-06-04",{"date":153,"type":154},"2026-06-05","ACTUAL",{"date":156,"type":154},"2023-09-21",{"date":158,"type":139},"2027-03-21",{"name":5,"class":6},7]