[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100175882":3},{"organization":4,"armGroups":7,"interventions":16,"overallOfficials":29,"centralContacts":21,"locations":34,"responsibleParty":46,"collaborators":49,"id":53,"slug":54,"hasResults":55,"nctId":56,"briefTitle":57,"officialTitle":58,"acronym":21,"eligibilityCriteria":59,"healthyVolunteers":55,"sex":60,"minAge":61,"maxAge":21,"enrollmentInfo":62,"targetDuration":21,"studyType":65,"phases":66,"briefSummary":68,"conditions":69,"keywords":21,"overallStatus":71,"whyStopped":72,"lastUpdateSubmitDate":73,"lastUpdatePostDateStruct":74,"startDateStruct":77,"completionDateStruct":79,"leadSponsor":81,"locationsCount":63},{"fullName":5,"class":6},"University Hospital, Bonn","OTHER",[8],{"label":9,"type":10,"description":11,"interventionNames":12},"Treatment","EXPERIMENTAL","Brain radiotherapy concomitant to lomustine and liposomal cytarabine chemotherapy.",[13,14,15],"Radiation: Brain radiotherapy (WBRT alone, SRT\u002FSRS alone or WBRT plus SRT\u002FSRS)","Drug: Lomustine","Drug: Liposomal cytarabine",[17,22,26],{"type":18,"name":19,"description":11,"armGroupLabels":20,"otherNames":21},"RADIATION","Brain radiotherapy (WBRT alone, SRT\u002FSRS alone or WBRT plus SRT\u002FSRS)",[9],null,{"type":23,"name":24,"description":11,"armGroupLabels":25,"otherNames":21},"DRUG","Lomustine",[9],{"type":23,"name":27,"description":11,"armGroupLabels":28,"otherNames":21},"Liposomal cytarabine",[9],[30],{"name":31,"affiliation":32,"role":33},"Martin Glas, PD Dr.","Neurologische Universitaetsklinik Bonn","PRINCIPAL_INVESTIGATOR",[35],{"facility":32,"status":21,"city":36,"state":21,"zip":37,"country":38,"countryCode":39,"cosmosGeoPoint":40,"geoPoint":45,"contacts":21},"Bonn","53127","Germany","DE",{"type":41,"coordinates":42},"Point",[43,44],7.09549,50.73438,{"lat":44,"lon":43},{"type":33,"investigatorFullName":47,"investigatorTitle":48,"investigatorAffiliation":5,"oldNameTitle":21,"oldOrganization":21},"PD Dr. Martin Glas","Deputy Director Division of Clinical Neurooncology Unit",[50],{"name":51,"class":52},"Mundipharma Research GmbH & Co KG","INDUSTRY","100175882","phase-1-a-clinical-trial-to-assess-the-safety--efficacy-of-the-treatment-of-patients-with-metastasis-from-malignant-melanoma---treatment-consists-of-the-substances-lomustine-capsules--cytarabine-injected-into-an-area-near-the-spinal-cord-accompanied-by-radiotherapy-of-the-brain-100175882",false,"NCT01563614","A Clinical Trial to Assess the Safety & Efficacy of the Treatment of Patients With Metastasis From Malignant Melanoma - Treatment Consists of the Substances Lomustine (Capsules) & Cytarabine (Injected Into an Area Near the Spinal Cord), Accompanied by Radiotherapy of the Brain","Safety and Efficacy of Liposomal Cytarabine in Combination With Radiotherapy (RT) and Lomustine for the Treatment of Leptomeningeal Metastasis From Malignant Melanoma","Inclusion Criteria:\n\n* Malignant melanoma (including melanoma of unknown primary site, recurrent and pretreated systemic melanoma and\u002For melanoma with parenchymal CNS metastases) with leptomeningeal metastasis as demonstrated by a positive CSF (cerebrospinal liquor) cytology AND\u002FOR by the presence of characteristic signs and symptoms of leptomeningeal metastasis supported by an MRI scan indicating the presence of meningeal tumour\n* CSF flow abnormalities must be excluded\n* Males or females ≥ 18 years of age\n* Karnofsky Performance Status \\> 50%\n* Adequate organ function (adequate bone marrow reserve, adequate liver function, adequate renal function. adequate blood clotting)\n\nExclusion Criteria:\n\n* Unresected parenchymal brain metastases with a diameter \\> 3 cm\n* Prior non melanoma malignancy (unless adequately treated carcinoma in situ of the cervix or non melanoma skin cancer)\n* Prior intrathecal chemotherapy\n* Prior treatment with systemic cytarabine or nitrosureas\n* The patient ist pregnant or breast feeding\n* Severe, active co-morbidities","ALL","18 Years",{"count":63,"type":64},1,"ACTUAL","INTERVENTIONAL",[67],"PHASE1","The purpose of this trial is to test the safety and tolerance of the combination therapy with cytarabine, lomustine and radiotherapy in patients with leptomeningeal metastasis from malignant melanoma.",[70],"Leptomeningeal Metastasis From Malignant Melanoma","TERMINATED","No patients can be recruited for this trial anymore due to other therapeutical approaches that became available.","2016-04-18",{"date":75,"type":76},"2016-04-19","ESTIMATED",{"date":78,"type":21},"2012-03",{"date":80,"type":64},"2015-11",{"name":5,"class":6}]