[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"neuroblastoma-in-children\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:neuroblastoma-in-children":26},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,3,0,[8,40,66],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":4,"eligibilityCriteria":15,"healthyVolunteers":11,"sex":16,"minAge":4,"maxAge":4,"enrollmentInfo":17,"targetDuration":4,"studyType":20,"phases":21,"briefSummary":23,"conditions":24,"keywords":4,"overallStatus":27,"whyStopped":4,"lastUpdateSubmitDate":28,"lastUpdatePostDateStruct":29,"startDateStruct":32,"completionDateStruct":34,"leadSponsor":36,"locationsCount":39},"100617454","phase-2-phase-ii-study-of-chidamide-dinutuximab-beta-irinotecan-temozolomide-for-refractoryrelapsed-neuroblastoma-in-children-100617454",false,"NCT07318831","Phase II Study of Chidamide-Dinutuximab Beta-Irinotecan-Temozolomide for Refractory\u002FRelapsed Neuroblastoma in Children","A Phase II Trial of Chidamide Combined With Dinutuximab Beta, Irinotecan, and Temozolomide for Refractory or Relapsed Neuroblastoma in Children","Inclusion Criteria:\n\n1. Patients with histologically diagnosed neuroblastoma, defined according to the International Neuroblastoma Risk Group (INRG) classification system or the Chinese expert consensus\u002Fguideline for pediatric neuroblastoma.\n2. Patients with relapsed or refractory neuroblastoma. Relapsed: any patient with recurrent neuroblastoma. Refractory: patients showing an inadequate response (partial response, minor response, or stable disease) to prior therapy, leading to progression.\n3. Prior treatment with epigenetic drugs (e.g., HDAC inhibitors, DNA methylation inhibitors) or GD2 monoclonal antibodies does not affect eligibility for this study.\n4. Presence of evaluable disease.\n5. Performance Status: Lansky score ≥50%, Karnofsky score ≥50%, or ECOG score ≤3.\n6. Life expectancy ≥12 weeks.\n7. Bone marrow function: Without bone marrow disease: Platelets ≥75×10⁹\u002FL, Absolute Neutrophil Count (ANC) ≥0.75×10⁹\u002FL, Hemoglobin ≥8 g\u002FdL (transfusion allowed). With bone marrow disease: Platelets ≥50×10⁹\u002FL, ANC ≥0.5×10⁹\u002FL, Hemoglobin ≥8 g\u002FdL (transfusion allowed).\n8. Renal function: No clinically significant proteinuria (morning urine dipstick \\\u003C2+). If proteinuria ≥2+ is detected, the protein-to-creatinine (Pr\u002FCr) ratio must be \\\u003C0.5 or 24-hour protein excretion must be \\\u003C0.5 g.\n9. Serum creatinine ≤1.5 × ULN; if higher, the calculated glomerular filtration rate (by radioisotope method) must be ≥60 mL\u002Fmin\u002F1.73 m².\n10. Hepatic function: AST or ALT ≤2.5 × ULN and total bilirubin ≤1.5 × ULN. In the presence of liver metastases: AST or ALT ≤5 × ULN and total bilirubin ≤2.5 × ULN.\n11. Cardiac function: Left ventricular shortening fraction ≥29% on echocardiogram.\n12. Coagulation: For patients not on anticoagulation therapy: INR ≤1.5 and APTT ≤1.5 × ULN. Anticoagulation is allowed if INR or APTT is within the therapeutic range (per institutional standards) and the patient has been on a stable dose for at least two weeks prior to study enrollment.\n13. Oxygen saturation \\>94% on room air.\n14. Ability to comply with the study visit schedule and other protocol requirements.\n\nExclusion Criteria:\n\n1. Patients with CTCAE v5.0 Grade 3 or higher toxicities involving hearing impairment, hematologic disorders, hepatic, or renal diseases.\n2. Patients with CTCAE v5.0 Grade 2 or higher neurotoxicity.\n3. Major surgical procedure within 14 days prior to the first dose of the study drug.\n4. Severe infection (requiring IV antibiotics, antifungals, or antivirals) within one week prior to treatment, or unexplained fever \\>38.5°C during screening or before the first dose.\n5. Congenital or acquired immunodeficiency, or active infectious diseases such as HIV or active hepatitis (with transaminase levels not meeting inclusion criteria; HBV DNA ≥1000 IU\u002FmL; HCV RNA ≥1000 IU\u002FmL). Chronic HBV carriers with HBV DNA \\\u003C2000 IU\u002FmL may be enrolled if they receive concurrent antiviral therapy during the trial.\n6. Any concomitant condition that, in the investigator's judgment, seriously jeopardizes patient safety, may confound the study results, or could impede the patient's completion of the study.","ALL",{"count":18,"type":19},27,"ESTIMATED","INTERVENTIONAL",[22],"PHASE2","This is a Phase II clinical trial investigating the effectiveness and safety of a four-drug combination-Chidamide, Dinutuximab Beta, Irinotecan, and Temozolomide-for children with relapsed or refractory neuroblastoma. The primary goal is to evaluate how well this regimen works to control the cancer, while the secondary goal is to closely monitor its safety and side effects in these young patients.",[25,26],"Neuroblastoma (NB)","Neuroblastoma in Children","RECRUITING","2026-06-02",{"date":30,"type":31},"2026-06-04","ACTUAL",{"date":33,"type":31},"2026-01-06",{"date":35,"type":19},"2028-12-31",{"name":37,"class":38},"Tianjin Medical University Cancer Institute and Hospital","OTHER",1,{"id":41,"slug":42,"hasResults":11,"nctId":43,"briefTitle":44,"officialTitle":44,"acronym":4,"eligibilityCriteria":45,"healthyVolunteers":11,"sex":16,"minAge":46,"maxAge":4,"enrollmentInfo":4,"targetDuration":4,"studyType":47,"phases":4,"briefSummary":48,"conditions":49,"keywords":4,"overallStatus":59,"whyStopped":4,"lastUpdateSubmitDate":60,"lastUpdatePostDateStruct":61,"startDateStruct":4,"completionDateStruct":4,"leadSponsor":63,"locationsCount":4},"100583143","expanded-access-protocol-for-the-use-of-sl-28-in-the-treatment-of-advanced-solid-tumors-100583143","NCT06872489","Expanded Access Protocol for the Use of SL-28 in the Treatment of Advanced Solid Tumors","Inclusion Criteria:\n\n* Subjects with locally advanced or metastatic solid tumor confirmed by histopathology;\n* Having at least one evaluable or measurable lesion according to the solid tumor response Evaluation Criteria (RECIST 1.1);\n* For patients with relapsed\u002Frefractory neuroblastoma with original diagnosis based on tumor histopathology, Karnofsky or Lansky performance status of ≥ 50%;\n* ECOG Performance Status from 0 or 3;\n* The expected survival time is more than 12 weeks;\n* 2 to 65+ old, gender is not limited;\n* The subjects gave informed consent to the study before participating in, and voluntarily signed informed consent;\n* Be able to comply with trial and follow-up procedures;\n* Adequate bone marrow and organ function;\n* Patients who have progressed, recurrent or refractory disease after first-line treatment (failure to obtain complete or partial remission after recent treatment);\n* Fertile women must agree to abstain from sex (abstaining from heterosexual intercourse)or use a highly effective method of contraception for at least one week from the time they sign an informed consent form until the last dose of the study drug.\n* The blood HCG test must be negative within 7 days before the start of the study treatment, and must be non-lactating;\n* For male patients whose partner is a woman of reproductive age, they must agree to abstain from sex for at least one week from signing the informed consent until the last dose of the study drug, or to use a highly effective method of contraception.\n* Immunotherapy: At least 42 days after completing any type of immunotherapy, including immune checkpoint;\n* Radiation therapy: 60 days should have elapsed in the case of completing radiation.\n* Cytokine therapy (e.g. G-CSF, GM-CSF, IL-6, IL-2): must be discontinued a minimum of 7 days prior to SL-28 therapy.\n\nExclusion Criteria:\n\n* Untreated or active primary central nervous system (CNS) tumor or metastasis;\n* Patients diagnosed of having primary and secondary immunodeficiencies;\n* Patients with disease of any major organ system that would compromise their ability to withstand therapy.\n* Arterial\u002Fvenous thrombosis events that occurred in the 12 months before enrollment, such as cerebrovascular accidents (including temporary ischemic attacks, cerebral hemorrhage, cerebral infarction), deep vein thrombosis, and pulmonary embolism;\n* Known allergy to any of the agents or their ingredients used in this study;\n* Patients who are on hemodialysis;\n* Pregnant or breast-feeding women; fertility patients who are unwilling or unable to take effective contraceptive measures;\n* Patients with untreated positive blood cultures or progressive infections.","2 Years","EXPANDED_ACCESS","This is an Expanded Access Program (EAP) that will give the participants access to the drug SL-28 before it is approved by the FDA. Participants in this study will have Advanced Solid Tumors who failed to respond to standard therapy (chemotherapy, immunotherapy) or developed progressive disease at any phase of standard therapy.\n\nResearchers think the SL-28 will be effective because SL-28 has a direct activity against different types of tumors.\n\nSL-28 is a cell-based therapy, based on leukocytes isolated from healthy donors and are activated through the proprietary process. After quality assessment (sterility, viable cell count, purity, and absence of infectious diseases), they are stored at -80°C until use. Upon need, the SL-28 is thawed, followed by checking their viability, count, and sterility. Adult and older adult patients aged 18 to 65+ who meet the eligibility criteria will be included in the study. Patients receive SL-28 IV once daily on days 1-5 and 8-12. Based on the patient's response, the need for additional injections will be evaluated. If improvements in the patient's condition are confirmed by MRI, further injections can continue on a rate 5 days a week.",[26,50,51,52,53,54,55,56,57,58],"Neuroblastoma, Recurrent, Refractory","Advanced Cancer","Advanced Malignant Neoplasm","Prostate Cancer Patients With Bone Metastasis","Lung Cancer Non-Small Cell Cancer (NSCLC)","Lung Cancer - Non Small Cell","Gastrointestinal Cancers","Head and Neck Cancer","Pancreatic Cancer","AVAILABLE","2025-07-17",{"date":62,"type":31},"2025-07-23",{"name":64,"class":65},"Second Life Therapeutics","INDUSTRY",{"id":67,"slug":68,"hasResults":11,"nctId":69,"briefTitle":70,"officialTitle":71,"acronym":4,"eligibilityCriteria":72,"healthyVolunteers":11,"sex":16,"minAge":46,"maxAge":73,"enrollmentInfo":74,"targetDuration":4,"studyType":20,"phases":76,"briefSummary":78,"conditions":79,"keywords":80,"overallStatus":27,"whyStopped":4,"lastUpdateSubmitDate":86,"lastUpdatePostDateStruct":87,"startDateStruct":89,"completionDateStruct":91,"leadSponsor":93,"locationsCount":39},"100567905","phase-1-safety-and-efficacy-of-systemic-allogenic-nk-cells-in-rr-neuroblastoma-100567905","NCT06674265","Safety and Efficacy of Systemic Allogenic NK Cells in R\u002FR Neuroblastoma","Evaluation of Safety and Efficacy Evaluation Post Intravenous Infusion of Activated NK Cells in Recurrent and Refractory High-risk Neuroblastoma Patients","Inclusion Criteria:\n\n1. High-risk neuroblastoma that is resistant to standard induction therapy based on COG (Children's Oncology Group) criteria (according to INRG criteria and having received at least 4 cycles of multi-drug induction chemotherapy, and not responding to conventional treatments).\n2. Evidence of relapse or progression of neuroblastoma after autologous peripheral blood stem cell transplantation or aggressive therapy.\n3. A minimum life expectancy of 6 months.\n4. Patients must have a pathological diagnosis of neuroblastoma and\u002For confirmation of tumor cells in the bone marrow with increased urinary catecholamines.\n5. Measurable residual disease based on imaging findings using Curie scoring or MIBG or PET imaging criteria (1: measurable tumor of at least 10 mm in one dimension on MRI or CT scan with positive uptake on I-123 MIBG scan (\"MIBG avid\") oOR 2): increased FDG uptake on 18F-FDG PET-CT or PET-MRI (\"PET avid\")).\n\n   \\-\n\nExclusion Criteria:\n\n1. Insufficient bone marrow function: Platelet count \\> 50,000\u002FµL, independent of transfusion (no platelet transfusion within one week). Absolute neutrophil count (ANC) maximum of 500 per microliter. Hemoglobin \\> 10 grams per deciliter.\n2. Insufficient liver function: Plasma bilirubin level more than 1.5 times the upper limit of normal (ULN). SGPT (ALT) at least three times the upper limit of normal (a level of 45 units per liter is considered the upper limit of normal).\n3. Insufficient kidney function: Creatinine clearance or estimated radioisotope GFR \\\u003C 70 ml\u002Fmin\u002F1.73m². Plasma creatinine level more than 1.5 times the upper limit of normal based on age\u002Fgender.\n4. Insufficient central nervous system function if seizures are present, entry into the study is not possible and if seizures are not well controlled with anticonvulsant drugs.\n\n3- Insufficient cardiovascular function Shortening fraction \\\u003C 27% by ECHO OR Ejection fraction \\\u003C 50% by ECHO or gated radionuclide study.\n\n4- Insufficient pulmonary function evidence of dyspnea at rest. Exercise intolerance. Chronic need for oxygen and room air pulse oximetry \\\u003C 94% if pulse oximetry evaluation is clinically indicated. Presence of current pleural or pericardial effusion.\n\n5- Inability to tolerate new treatment due to emergency conditions. 6- Elevated catecholamines (more than twice the ULN) or sole involvement of bone marrow (bone marrow positive for NB as the only evaluable disease without confirmatory pathology report).\n\n7- Receiving 0.5 mg\u002Fkg\u002Fday of systemic steroids (equivalent to prednisone) for at least 7 days before enrollment.\n\n8- Receiving CYP3A4 inducers or inhibitors at least 7 days before study enrollment.\n\n9- Diagnosis of any other malignancy alongside the diagnosis of neuroblastoma. 10- Diarrhea \\> Grade 2 (4 to 6 stools per day). 11- Significant illness not covered by exclusion criteria but interfering with the study process or increasing the intensity of treatment with NK cells.\n\n12- Participation in another clinical trial. 13- Severe impairment of major organ functions, such as renal, cardiac, hepatic, neurological, pulmonary, or gastrointestinal toxicity above Grade 2 according to the National Cancer Institute's Common Terminology Criteria for Adverse Events version 5.0 (CTC v5.0).\n\n14- Inability to comply with protocol requirements. 15- Lack of confirmed and signed consent by the patient's guardians. 16- Evidence of HIV disease (Human Immunodeficiency Virus) or positive serology for HIV.","16 Years",{"count":75,"type":19},10,[77],"PHASE1","The goal of this clinical trial is to assess safety and efficacy of systemic injection of allogenic NK cells in patients with refractory\u002Frecurrent high-risk neuroblastoma.\n\nIs the injection of allogenic nk cells safe in patients with R\u002FR high-risk neuroblastoma? Is the injection of allogenic nk cells effective in patients with R\u002FR high-risk neuroblastoma? We will compare the NK cell administration group with a control group that receives conventional treatment to determine whether the intervention is safe and effective",[50,25,26],[81,82,83,84,85],"Neuroblastoma","High-Risk Neuroblastoma","Natural Killer Cell","Nk Cell","adrenal gland","2025-04-05",{"date":88,"type":31},"2025-04-09",{"date":90,"type":31},"2024-11-10",{"date":92,"type":19},"2026-11",{"name":94,"class":65},"Marzieh Ebrahimi"]