[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100574502":3},{"organization":4,"armGroups":7,"interventions":20,"overallOfficials":35,"centralContacts":40,"locations":49,"responsibleParty":68,"collaborators":26,"id":70,"slug":71,"hasResults":72,"nctId":73,"briefTitle":74,"officialTitle":75,"acronym":26,"eligibilityCriteria":76,"healthyVolunteers":72,"sex":77,"minAge":26,"maxAge":78,"enrollmentInfo":79,"targetDuration":26,"studyType":82,"phases":83,"briefSummary":85,"conditions":86,"keywords":88,"overallStatus":52,"whyStopped":26,"lastUpdateSubmitDate":91,"lastUpdatePostDateStruct":92,"startDateStruct":95,"completionDateStruct":97,"leadSponsor":99,"locationsCount":100},{"fullName":5,"class":6},"Sun Yat-sen University","OTHER",[8,16],{"label":9,"type":10,"description":11,"interventionNames":12},"Phase Ia","EXPERIMENTAL","A phase Ia dose escalation study of temozolomide and vincristine at fixed doses and escalating doses of irinotecan (patients with wild-type UGT1A1 \\*6 (T\u002FT) genotype are eligible for dose escalation of irinotecan) for the treatment of relapsed\u002Frefractory pediatric solid tumors. The standard 3+3 patient enrollment design was adopted.",[13,14,15],"Drug: Irinotecan (CPT-11)","Drug: Temozolomide (TMZ)","Drug: Vincristine",{"label":17,"type":6,"description":18,"interventionNames":19},"Phase Ib","In the VIT regimen, irinotecan will be administered using the RP2D dose determined by Phase Ia, with an expansion to 9-12 additional patients to further explore efficacy and safety.",[13,14,15],[21,27,31],{"type":22,"name":23,"description":24,"armGroupLabels":25,"otherNames":26},"DRUG","Irinotecan (CPT-11)","Irinotecan will start at a dose of 50mg\u002Fm² and escalate to explore the maximum tolerated dose.",[9,17],null,{"type":22,"name":28,"description":29,"armGroupLabels":30,"otherNames":26},"Temozolomide (TMZ)","TMZ：100mg\u002Fm2\u002Fd，d1-5",[9,17],{"type":22,"name":32,"description":33,"armGroupLabels":34,"otherNames":26},"Vincristine","VCR: 1.5mg\u002Fm2\u002Fd(≯2mg), d1",[9,17],[36],{"name":37,"affiliation":38,"role":39},"Yizhuo Zhang","SunYat Sen University Cancer Center","PRINCIPAL_INVESTIGATOR",[41,45],{"name":37,"role":42,"phone":43,"phoneExt":26,"email":44},"CONTACT","02087342460","zhangyzh@sysucc.org.cn",{"name":46,"role":42,"phone":47,"phoneExt":26,"email":48},"Juan Juan","87342460","wangjuan@sysucc.org.cn",[50],{"facility":51,"status":52,"city":53,"state":54,"zip":55,"country":56,"countryCode":57,"cosmosGeoPoint":58,"geoPoint":63,"contacts":64},"Sun Yat-sen University Cancer Center","RECRUITING","Guangzhou","Guangdong","510060","China","CN",{"type":59,"coordinates":60},"Point",[61,62],113.25,23.11667,{"lat":62,"lon":61},[65],{"name":66,"role":42,"phone":67,"phoneExt":26,"email":44},"Yi-Zhuo Zhang","08602087342460",{"type":39,"investigatorFullName":37,"investigatorTitle":69,"investigatorAffiliation":5,"oldNameTitle":26,"oldOrganization":26},"Prof","100574502","phase-1-ugt1a1-genotype-drien-phase-i-study-of-irinotecan-in-vit-regimen-for-the-treatment-of-pediatric-rr-solid-tumors-100574502",false,"NCT06760117","UGT1A1 Genotype-drien Phase I Study of Irinotecan in VIT Regimen for the Treatment of Pediatric R\u002FR Solid Tumors","Phase I Study of Irinotecan Dose Adjustment Guided by UGT1A1*6 Genotype in VIT Regimen for the Treatment of Relapsed and Refractory Childhood Solid Tumors","Inclusion Criteria:\n\n1. Age \\\u003C 18 years.\n2. Relapsed and refractory childhood solid tumors (pathologically confirmed). Definition of relapsed and refractory patients: 1. Patients who fail to achieve GPR or CR after first-line treatment are defined as refractory; 2. Patients who achieve CR after first-line treatment but relapse after more than 1 month are defined as relapsed.\n3. Must have undergone UGT1A1\\*6 genotype testing (provided free of charge by Jiangsu Hengrui Medicine Co., Ltd.), with results being wild type (T\u002FT).\n4. Patients must be at least 3 weeks post the last myelosuppressive chemotherapy and at least 6 months post hematopoietic stem cell transplantation, 2 weeks post local radiotherapy, 6 months post craniospinal or extensive pelvic radiotherapy, or 6 weeks post extensive bone marrow radiotherapy.\n5. Must have at least one measurable lesion as defined by RECIST criteria;\n6. Karnofsky score (for ages \\> 10, see Annex I) or Lansky score (for ages ≤ 10, see Annex II) ≥ 50 points;\n7. Expected survival time ≥ 6 months;\n8. Patients must have fully recovered from all acute toxic effects of previous anticancer chemotherapy: a) Bone marrow suppression chemotherapy: at least 21 days post the last bone marrow suppressive chemotherapy; b) Hematopoietic growth factors: at least 14 days post the last dose of long-acting growth factor or 7 days post the last dose of short-acting growth factor;\n9. For patients known not to involve the BM: a) Absolute neutrophil count (ANC) ≥ 1.0×10⁹\u002FL; b) Non-transfused platelet count ≥ 100.0×10⁹\u002FL; c) Hemoglobin ≥ 80 g\u002FL;\n10. Liver and kidney functions must meet the following criteria: a) Total bilirubin (conjugated + unconjugated) ≤ 1.5× upper limit of normal (ULN) for age; b) Aspartate aminotransferase (AST) ≤ 2.5×ULN (≤ 110 U\u002FL); c) Glomerular filtration rate or creatinine clearance ≥ 70 mL\u002Fmin\u002F1.73 m² or corresponding age-normal serum creatinine; d) Serum albumin ≥ 20 g\u002FL.\n11. Capable of adhering to outpatient treatment, laboratory monitoring, and necessary clinical visits during the study period;\n12. Parents\u002Fguardians of children or adolescent subjects must be able to understand, consent to, and sign the informed consent form (ICF) and applicable child consent forms before initiating any protocol-related procedures; if parents\u002Fguardians agree, subjects must be capable of expressing consent (when applicable).\n\nExclusion Criteria:\n\n1. Patients who have previously received chemotherapy with irinotecan combined with temozolomide and vincristine, or patients who have progressed after receiving treatment with irinotecan or temozolomide;\n2. Patients receiving P450 enzyme-inducing antiepileptic drugs (antiepileptic drugs affect the clearance of irinotecan);\n3. During the study period, patients must not receive any other chemotherapy, radiotherapy, or granulocyte colony-stimulating therapy;\n4. Patients positive for hepatitis B surface antigen;\n5. Patients infected with HIV or syphilis;\n6. Patients who have previously undergone organ transplantation;\n7. Uncontrolled active systemic bacterial, viral, or fungal infections; Clostridium difficile infection requiring treatment;\n8. Patients allergic to dacarbazine or cephalosporin drugs;\n9. Patients requiring high-dose dexamethasone treatment;\n10. Patients with a severe history of neurological or psychiatric disorders, including epilepsy or autism.","ALL","18 Years",{"count":80,"type":81},39,"ESTIMATED","INTERVENTIONAL",[84],"PHASE1","Irinotecan is a commonly used salvage chemotherapy drug for children with relapsed and refractory solid tumors. Common dose-limiting toxicities of irinotecan include abdominal pain and diarrhea. Studies have shown that patients with UGT1A16 gene mutations have a higher incidence of these side effects, thereby limiting the dosage of irinotecan. The combination of irinotecan with temozolomide and vincristine is a common salvage chemotherapy regimen for children with relapsed and refractory solid tumors. Currently, the recommended dose of irinotecan is 50mg\u002Fm², but there is still significant room for improvement in the efficacy of VIT for these children. Whether patients with wild-type UGT1A16 can further increase the dosage of irinotecan, thereby enhancing the efficacy of the VIT regimen, is the focus of our research.",[87],"Pediatric Solid Tumor",[89,90],"UGT1A1 gene","irinotecan","2024-12-30",{"date":93,"type":94},"2025-01-06","ACTUAL",{"date":96,"type":94},"2022-01-01",{"date":98,"type":81},"2025-12",{"name":5,"class":6},1]