[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100644426":3},{"organization":4,"armGroups":7,"interventions":17,"overallOfficials":34,"centralContacts":38,"locations":43,"responsibleParty":62,"collaborators":10,"id":64,"slug":65,"hasResults":66,"nctId":67,"briefTitle":68,"officialTitle":68,"acronym":10,"eligibilityCriteria":69,"healthyVolunteers":66,"sex":70,"minAge":71,"maxAge":10,"enrollmentInfo":72,"targetDuration":10,"studyType":75,"phases":10,"briefSummary":76,"conditions":77,"keywords":10,"overallStatus":46,"whyStopped":10,"lastUpdateSubmitDate":83,"lastUpdatePostDateStruct":84,"startDateStruct":87,"completionDateStruct":89,"leadSponsor":91,"locationsCount":92},{"fullName":5,"class":6},"M.D. Anderson Cancer Center","OTHER",[8],{"label":9,"type":10,"description":11,"interventionNames":12},"Single Arm",null,"Undergo tandem autologous transplantation with conditioning chemotherapy that includes gemcitabine, docetaxel, melphalan and carboplatin (GemDMC) followed by transplantation with carboplatin and etoposide (CE).",[13,14,15,16],"Drug: Gemcitabine (GEM)","Drug: Docetaxel","Drug: Melphalan","Drug: Carboplatin",[18,23,27,31],{"type":19,"name":20,"description":21,"armGroupLabels":22,"otherNames":10},"DRUG","Gemcitabine (GEM)","Give by Iv",[9],{"type":19,"name":24,"description":25,"armGroupLabels":26,"otherNames":10},"Docetaxel","Given by Iv",[9],{"type":19,"name":28,"description":29,"armGroupLabels":30,"otherNames":10},"Melphalan","Given by IV",[9],{"type":19,"name":32,"description":25,"armGroupLabels":33,"otherNames":10},"Carboplatin",[9],[35],{"name":36,"affiliation":5,"role":37},"Irtiza N Sheikh, MD","PRINCIPAL_INVESTIGATOR",[39],{"name":36,"role":40,"phone":41,"phoneExt":10,"email":42},"CONTACT","(832) 728-9791","isheikh1@mdanderson.org",[44],{"facility":45,"status":46,"city":47,"state":48,"zip":49,"country":50,"countryCode":51,"cosmosGeoPoint":52,"geoPoint":57,"contacts":58},"MD Anderson Cancer Center","RECRUITING","Houston","Texas","77030","United States","US",{"type":53,"coordinates":54},"Point",[55,56],-95.36327,29.76328,{"lat":56,"lon":55},[59,61],{"name":36,"role":40,"phone":60,"phoneExt":10,"email":42},"832-728-9791",{"name":36,"role":37,"phone":10,"phoneExt":10,"email":10},{"type":63,"investigatorFullName":10,"investigatorTitle":10,"investigatorAffiliation":10,"oldNameTitle":10,"oldOrganization":10},"SPONSOR","100644426","prospective-observational-study-of-outcomes-after-gemcitabine-docetaxel-melphalan-and-carboplatin-with-autologous-stem-cell-transplantation-in-pediatric-relapsedrefractory-germ-cell-tumors-100644426",false,"NCT07662018","Prospective Observational Study of Outcomes After Gemcitabine, Docetaxel, Melphalan, and Carboplatin With Autologous Stem Cell Transplantation in Pediatric Relapsed\u002FRefractory Germ Cell Tumors","Inclusion Criteria\n\n* Male or female participants, greater than 1 month of age up to 21 years old. Neonates (birth to 1 month of age) will not be enrolled on this protocol.\n* Participants with relapsed\u002Frefractory seminomatous or nonseminomatous GCT who undergo an autologous stem cell transplantation (ASCT) with conditioning therapy including gemcitabine, docetaxel, melphalan, carboplatin (GemDMC) for germ cell tumors\n* As part of our analysis, we will also include participants aged 0-21 years old who have previously underwent ASCT with GemDMC\n* Participants who receive the following regimen:\n\nHigh dose chemotherapy (HDC) course #1:\n\nGemcitabine\u002FDocetaxel\u002FMelphalan\u002FCarboplatin D-6 Admission and start hydration D-5 Gemcitabine 1,500 mg\u002Fm2 IV Docetaxel 275 mg\u002Fm2 IV D-4 Gemcitabine 1,500 mg\u002Fm2 IV Melphalan 20 mg\u002Fm2 IV Carboplatin 250 mg\u002Fm2 IV D-3 Gemcitabine 1,500 mg\u002Fm2 IV Melphalan 20 mg\u002Fm2 IV Carboplatin 250 mg\u002Fm2 IV D-2 Gemcitabine 1,500 mg\u002Fm2 IV Melphalan 20 mg\u002Fm2 IV Carboplatin 250 mg\u002Fm2 IV D-1 Rest D0 Stem Cell infusion\n\nFollowed by HDC course #2 consisting of:\n\nHigh-dose course #2: Carboplatin\u002FEtoposide D-6 Admission and start hydration D-5 to -3 Etoposide 750 mg\u002Fm2 IV Carboplatin 700 mg\u002Fm2 IV D-2 Rest D-1 Rest D0 Stem Cell infusion\n\nExclusion Criteria\n\n* Participants who do not or did not receive GemDMC as part of the conditioning regimen for an ASCT are not eligible for this study","ALL","21 Years",{"count":73,"type":74},30,"ESTIMATED","OBSERVATIONAL","To collect information about treatment outcomes in pediatric and adolescent patients with relapsed\u002Frefractory germ cells tumors who receive GemDMC with an ASCT.",[78,79,24,28,32,80,81,82],"Prospective Observational Study","Gemcitabine","Stem Cell Transplantation","Pediatric Relapsed","Refractory Germ","2026-06-17",{"date":85,"type":86},"2026-06-23","ACTUAL",{"date":88,"type":86},"2026-06-05",{"date":90,"type":74},"2033-12-31",{"name":5,"class":6},1]