[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100634975":3},{"organization":4,"armGroups":7,"interventions":20,"overallOfficials":26,"centralContacts":30,"locations":26,"responsibleParty":36,"collaborators":40,"id":47,"slug":48,"hasResults":49,"nctId":50,"briefTitle":51,"officialTitle":52,"acronym":53,"eligibilityCriteria":54,"healthyVolunteers":49,"sex":55,"minAge":56,"maxAge":26,"enrollmentInfo":57,"targetDuration":26,"studyType":60,"phases":61,"briefSummary":63,"conditions":64,"keywords":26,"overallStatus":66,"whyStopped":26,"lastUpdateSubmitDate":67,"lastUpdatePostDateStruct":68,"startDateStruct":71,"completionDateStruct":73,"leadSponsor":75,"locationsCount":26},{"fullName":5,"class":6},"University Hospital, Essen","OTHER",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"Arm A Control Group, standard of care trimodality treatment (neurosurgical resection + R(C)Tx)","ACTIVE_COMPARATOR","Standard of care trimodality treatment (neurosurgical resection + R(C)Tx) without additional vaccination",[13],"Other: Standard of care treatment without additional vaccination",{"label":15,"type":16,"description":17,"interventionNames":18},"Arm B, interventional arm, trimodality treatment and vaccination against herpes zoster","EXPERIMENTAL","Trimodality treatment and vaccination against herpes zoster",[19],"Biological: Additional vaccination against shingles (herpes zoster)",[21,27],{"type":22,"name":23,"description":24,"armGroupLabels":25,"otherNames":26},"BIOLOGICAL","Additional vaccination against shingles (herpes zoster)","Based on patient-preference patients receive autologous CMV-specific T-cells additionally to vaccination contra herpes zoster after completion of radio(chemo-)therapy. Patients included in the experimental arm shall be HLA typed. Up to 6 intravenous infusions of in vitro-expanded T cells at a dose of 2 × 107 cells\u002Fm2 body surface area every 2 to 4 weeks shall be administered after clinical assessment. Patients shall continue standard-of-care treatment with temozolomide if indicated. Where possible, administration of autologous T-cells shall be scheduled to fall between chemotherapy treatment weeks to avoid concurrent infusions",[15],null,{"type":6,"name":28,"description":28,"armGroupLabels":29,"otherNames":26},"Standard of care treatment without additional vaccination",[9],[31],{"name":32,"role":33,"phone":34,"phoneExt":26,"email":35},"Prof. Dr.med. Guberina","CONTACT","+492017232054","strahlentherapie@uk-essen.de",{"type":37,"investigatorFullName":38,"investigatorTitle":39,"investigatorAffiliation":5,"oldNameTitle":26,"oldOrganization":26},"PRINCIPAL_INVESTIGATOR","Nika Guberina","Prof. Dr.med.",[41,43,45],{"name":42,"class":6},"Karolinska Institutet",{"name":44,"class":6},"Leiden University Medical Center",{"name":46,"class":6},"Universitätsklinikum Hamburg-Eppendorf","100634975","phase-4-efficacy-of-zoster-vaccination-in-glioblastoma-patients-100634975",false,"NCT07546669","Efficacy of Zoster Vaccination in Glioblastoma Patients","Herpes Zoster Vaccine and Autologous CMV-specific T Cells as an Immunomodulatory Adjunct to Standard Neurosurgical Resection Radiochemotherapy in Glioblastoma","STARGATE","Inclusion Criteria:\n\nSubjects must meet all of the following inclusion criteria to be eligible for enrolment into the trial:\n\n* At least 18 years of age\n* Written informed consent of the subject\n* Life expectancy at least 3 months\n* Participants of child-bearing age must use effective contraception\n* Indication for definitive radiotherapy of glioblastoma or adjuvant radiation therapy of glioblastoma resection cavity according to interdisciplinary tumor board consensus and after radiation oncologists evaluation\n* Histopathologically proven glioblastoma\n* Incorporation of pre-neurochirurgical \u002F-treatment PET\u002FCT or\u002F and PET\u002FMRI findings into the radiation therapy plan if patient undergoes PET\u002FCT or\u002F and PET\u002FMRI\n\nExclusion Criteria:\n\nSubjects will not be included in the study if any of the following criteria apply. General Exclusion Criteria:\n\n* Subjects not able to give consent\n* Subject without legal capacity who is unable to understand the nature, scope, significance, and con- sequences of this clinical trial\n* Simultaneously participation in another clinical trial or participation in any clinical trial involving ad- ministration of an investigational medicinal product within 30 days prior to clinical trial beginning\n* Subjects with a physical or psychiatric condition which at the investigator's discretion may put the subject at risk may confound the trial results or may interfere with the subject's participation in this clinical trial\n* Known or persistent abuse of medication, drugs or alcohol\n* Contraindications for radiotherapy (including active inflammatory disease)\n* Known hypersensitivity against vaccine contra herpes zoster, or its constituents\n* Gliomatosis cerebri at time of enrollment on any imaging or proved by histopathology\n* Synchronous secondary malignancy\n\nExclusion criteria regarding special restrictions for females as the treatment procedures require the highest degree of safety for the child:\n\n* Current or planned pregnancy or nursing women\n* Females of child-bearing potential, who are not using and not willing to use medically reliable methods of contraception for the entire study duration (such as oral, injectable, or implantable contracep- tives, or intrauterine contraceptive devices) unless they are surgically sterilized \u002F hysterectomized or there are any other criteria considered sufficiently reliable by the investigator in individual cases\n\nIndication-specific exclusion criteria in order to guarantee the highest degree of safety of all treatment procedures from a medical point of view:\n\n* Primary infra-tentorial located glioblastoma (justification: specific subgroup of patients with different prognosis)\n* Significant comorbidities at baseline, which would prevent possible chemotherapy, including:\n\n  i. Platelet count \\\u003C 100\u002Fnl ii. Absolute neutrophil count (ANC) \\\u003C 1.5\u002Fnl iii. AST or ALT \\> 3 times the upper limit of normal iv. Total bilirubin above the normal range v. Serum creatinine \\> 1.7 mg\u002Fdl\n* Patients with clinically significant liver-, renal- or blood disorder\n* Patients with known additional significant neurological disease (e.g. primary seizure disorder\\*, de-mentia, progressive degenerative neurological disease, meningitis or encephalitis, hydrocephalus with increased intracranial pressure)\n* Patients with brain tumor-related epilepsy, seizure-free under antiepileptic therapy are eligible\n* Active implanted medical device (e.g. deep brain stimulators, spinal cord stimulators, vagus nerve stimulators, pacemakers, defibrillators and programmable shunts) or documented clinically signifi- cant arrhythmias\n* History of HIV infection","ALL","18 Years",{"count":58,"type":59},230,"ESTIMATED","INTERVENTIONAL",[62],"PHASE4","In modern practice a trimodality treatment has emerged as standard of care for histologically confirmed glioblastoma.\n\nWe hypothesize that the additional vaccination against herpes zoster, after surgical resection followed by irradiation therapy and chemotherapy of patients with glioblastoma will lead to a superior local control, overall and progression free survival. In an additional experimental setting based on patient preference the immunological effectiveness of the adoptive transfer of autologous polyclonal cytomegalovirus (CMV) specific T cells will be examined.",[65],"Glioblastoma (GBM)","NOT_YET_RECRUITING","2026-04-16",{"date":69,"type":70},"2026-04-23","ACTUAL",{"date":72,"type":59},"2027-01-02",{"date":74,"type":59},"2030-12-31",{"name":5,"class":6}]