[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"olfactory-neuroblastoma\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:olfactory-neuroblastoma":24},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,3,0,[8,45,81],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":13,"acronym":4,"eligibilityCriteria":14,"healthyVolunteers":11,"sex":15,"minAge":16,"maxAge":17,"enrollmentInfo":18,"targetDuration":4,"studyType":21,"phases":4,"briefSummary":22,"conditions":23,"keywords":26,"overallStatus":32,"whyStopped":4,"lastUpdateSubmitDate":33,"lastUpdatePostDateStruct":34,"startDateStruct":37,"completionDateStruct":39,"leadSponsor":41,"locationsCount":44},"100420472","a-natural-history-study-of-children-and-adults-with-olfactory-neuroblastoma-100420472",false,"NCT04755205","A Natural History Study of Children and Adults With Olfactory Neuroblastoma","* INCLUSION CRITERIA:.\n* Subjects with histologically documented olfactory neuroblastoma.\n* Age \\>= 3 years old.\n* Ability of subject to understand and the willingness to sign a written consent document\n\nEXCLUSION CRITERIA:\n\nPregnant women are excluded from this study because of more than minimal risk activities (imaging studies with contrast, biopsies) pertaining to enrollment.","ALL","3 Years","120 Years",{"count":19,"type":20},525,"ESTIMATED","OBSERVATIONAL","Background:\n\nOlfactory neuroblastoma (ONB) is a rare cancer. It grows from tissue in the upper part of the nose cavity, related to the sense of smell and can affect a person s sense of smell. Researchers want to better understand the health problems of people with ONB. This may help them design better treatment and supportive care studies.\n\nObjective:\n\nTo better understand ONB-the course of the disease, tumor characteristics, response to treatments, and management of the treatment.\n\nEligibility:\n\nPeople ages 3 years and older who have ONB. They must enroll in NIH studies #19-C-0016 and #18-DC-0051.\n\nDesign:\n\nParticipants will be screened with a medical history and medical record review.\n\nParticipants do not have to visit NIH.\n\nParticipants will give a blood sample. They will complete surveys to assess their emotional and physical wellbeing and needs. Leftover tissue from biopsies and surgeries will be collected.\n\nParticipants will take smell tests. They will smell items and answer questions about them.\n\nParticipants may take taste tests. They will get plastic taste strips that they will move around their mouth to determine the taste.\n\nParticipants may have a physical exam. Their performance status may be assessed.\n\nParticipants may give blood, saliva, urine, and nasal secretion samples.\n\nParticipants may have computed tomography and\u002For magnetic resonance imaging scans.\n\nParticipants may have one or more tumor biopsies.\n\nParticipants will talk to the research team about the results of their medical record\u002Ftests evaluation. The team will recommend how to best manage and treat their disease.\n\nParticipants may give samples and complete surveys every 12 months. Their medical records will be reviewed every year. They will be monitored for the rest of their life.",[24,25],"Olfactory Neuroblastoma","Esthesioneuroblastoma",[27,28,29,30,31],"esthesioneuroblastoma","nasal cavity tumor","pediatric onb","adult onb","Natural History","RECRUITING","2026-06-27",{"date":35,"type":36},"2026-06-30","ACTUAL",{"date":38,"type":36},"2022-06-02",{"date":40,"type":20},"2029-12-31",{"name":42,"class":43},"National Cancer Institute (NCI)","NIH",1,{"id":46,"slug":47,"hasResults":11,"nctId":48,"briefTitle":49,"officialTitle":50,"acronym":4,"eligibilityCriteria":51,"healthyVolunteers":11,"sex":15,"minAge":52,"maxAge":17,"enrollmentInfo":53,"targetDuration":4,"studyType":55,"phases":56,"briefSummary":58,"conditions":59,"keywords":68,"overallStatus":32,"whyStopped":4,"lastUpdateSubmitDate":73,"lastUpdatePostDateStruct":74,"startDateStruct":76,"completionDateStruct":78,"leadSponsor":80,"locationsCount":44},"100552955","phase-1-212pbvmt-alpha-net-in-metastatic-or-inoperable-somatostatin-receptor-positive-gastrointestinal-neuroendocrine-tumors-pheochromocytomaparagangliomas-small-cell-lung-renal-cell-and-head-and-neck-cancers-100552955","NCT06479811","[212Pb]VMT-Alpha-NET in Metastatic or Inoperable Somatostatin-Receptor Positive Gastrointestinal Neuroendocrine Tumors, Pheochromocytoma\u002FParagangliomas, Small Cell Lung, Renal Cell, and Head and Neck Cancers","Phase I Trial of [212Pb]VMT-Alpha-NET in Metastatic or Inoperable Somatostatin-Receptor Positive Gastrointestinal Neuroendocrine Tumors, Pheochromocytoma\u002FParagangliomas, Small Cell Lung, Renal Cell, and Head and Neck Cancers","* INCLUSION CRITERIA:\n* Participants must have histopathologically confirmed gastrointestinal neuroendocrine tumors (GI NET), pheochromocytoma\u002Fparaganglioma (PPGL), small cell lung cancers (SCLC), kidney cancers (KC), or Head \\& Neck cancers (nasopharyngeal carcinoma \\[NPC\\], olfactory neuroblastoma \\[ONB\\], sinonasal neuroendocrine carcinoma \\[SNEC\\]) that are metastatic or inoperable per Standard of Care. Note: for KC, all histopathologies of kidney cancers are eligible as long as it is a primary renal neoplasm.\n* Required prior therapies:\n* GI NET, PPGL, H\\&N: no specific prior therapy is needed.\n* SCLC: At least one prior line of standard of care systemic treatment such as chemotherapy and\u002For immunotherapy.\n* KC: Renal cell carcinoma (RCC) participants should have received at least one line of prior therapy in the metastatic setting and should have received at least one Programmed cell death protein 1 (PD1) \u002F Programmed death-ligand 1 (PDL1)-targeted immune checkpoint inhibitor as well as one agent targeting the VEGF pathway. Participants with fumarate hydratase (FH) deficient RCC should have received at least one prior line of systemic therapy (such as bevacizumab plus erlotinib). No prior therapy is needed for participants with other histologic subtypes.\n* Have NOT received prior systemic radioligand therapy for definitive therapeutic purposes. Prior external beam radiation therapy is allowed.\n* History of disease progression by imaging (e.g., RECIST 1.1) or clinically (defined as increase in severity or frequency of symptoms related to disease) within the past 36 months prior to the first dose of \\[203Pb\\]VMT-Alpha-NET.\n* Evidence of somatostatin receptors (SSTR) expression on at least 50% of the radiographically identifiable (i.e., visible on an anatomic scan such as CT or magnetic resonance imaging \\[MRI\\]) tumor, as indicated by a positive (uptake qualitatively identifiable as above the local background) on SSTR PET scan.\n* Age \\>= 18 years.\n* ECOG performance status \\\u003C=1.\n* Participants must have adequate organ and marrow function as defined below:\n\n  * Leukocytes: 3,000\u002Fmicroliter\n  * Absolute Neutrophil Count: 1,500\u002Fmicroliter\n  * Platelets 100,000\u002Fmicroliter\n  * Hemoglobin \\>= 9.0 g\u002FdL\n  * Total bilirubin: within normal institutional limits. Note: \\\u003C= 5 X institutional upper limit of normal (ULN) if bilirubin elevation is due to a benign process such as Gilbert syndrome\n  * AST: \\\u003C= 2.5 X institutional ULN\n  * ALT: \\\u003C= 2.5 X institutional ULN\n  * Creatinine: within normal institutional limits\n\nOR\n\n* Calculated creatinine clearance (glomerular filtration rate (eGFR): \\>= 60 mL\u002Fmin\u002F1.73 m\\^2 for participants with creatinine levels above institutional normal\n\n  * Participants with treated brain metastases are eligible if follow-up brain imaging after central nervous system (CNS)-directed therapy shows no evidence of progression at screening.\n  * Participants with new or progressive brain metastases or leptomeningeal disease are eligible as long as the participant is asymptomatic and not requiring medication for symptom control from the brain lesions at screening.\n  * Participants seropositive for human immunodeficiency virus (HIV) must:\n* be on effective anti-retroviral therapy; and\n* have an undetectable viral load at screening.\n\n  * Participants seropositive for hepatitis B virus (HBV), must have HBV viral load undetectable at screening.\n  * Participants seropositive for hepatitis C virus (HCV) must:\n* received curative treatment; and\n* have an undetectable HCV viral load at screening.\n\n  * Individuals of child-bearing potential (IOCBP) and individuals who can father children must agree to use an effective method of contraception (barrier, hormonal, intrauterine device \\[IUD\\], surgical sterilization, abstinence) at study entry and up to 6 months after the last dose of the study agent(s).\n  * Nursing participants must be willing to discontinue nursing from study treatment initiation through 6 months after the last dose of the study agents.\n  * The ability of the participant to understand and the willingness to sign a written informed consent document.\n\nEXCLUSION CRITERIA:\n\n* Any investigational agents should be stopped at least 28 days prior to the first dose of \\[203Pb\\]VMT-Alpha-NET.\n* Systemic therapy should be stopped at least 28 days prior to the first dose of \\[203Pb\\]VMT-Alpha-NET (participants with prior systemic therapies for their malignancy only, except participants with SCLC).\n* Systemic therapy should be stopped at least 14 days prior to the first dose of \\[203Pb\\]VMT-Alpha-NET (participants with SCLC only).\n* History of allergic reactions attributed to compounds of similar chemical or biologic composition to VMT-Alpha-NET.\n* Positive Beta human chorionic gonadotropin (Beta-HCG) serum or urine pregnancy test performed in IOCBP at screening.\n* QTc \\> 450 ms on electrocardiogram (EKG) at screening. Note: Framingham correction for QTc will be used\n* History of or detection at screening of active\u002Funtreated secondary malignancy except nonmelanoma skin cancer and carcinoma in situ of the uterine cervix.\n* Uncontrolled intercurrent illness, factors, evaluated by medical history and physical exam which would potentially increase in the risk of the participant.","18 Years",{"count":54,"type":20},120,"INTERVENTIONAL",[57],"PHASE1","Background:\n\nSome cancers have high levels of proteins called somatostatin receptors (SSTRs) on the surface of the tumors. These tumors can be in the lung, head and neck, digestive tract, kidneys, and in or near the adrenal glands. Researchers want to know if drug treatments that target SSTRs can help shrink these types of tumors.\n\nObjective:\n\nTo test a study drug (\\[212Pb\\]VMT-Alpha-NET) in people with tumors that have SSTRs.\n\nEligibility:\n\nPeople aged 18 years and older with tumors of the lung, kidneys, head and neck, digestive tract, or adrenal glands that have SSTRs. Their tumors must have spread to other organs and cannot be removed with surgery.\n\nDesign:\n\nParticipants will be screened. They will have a physical exam with blood and urine tests. They will have imaging scans and a test of their heart function. A sample of tumor tissue may be collected if one is not already available.\n\n\\[212Pb\\]VMT-Alpha-NET is given through a tube attached to a needle inserted into a vein. The drug will be given on the first day of four 8-week cycles. Participants will stay in the hospital for a few nights after each dose. They will have blood tests once a week during each cycle.\n\nSome participants will also get a related study drug (\\[203Pb\\]VMT-Alpha-NET). They will receive this drug a few days before the first 2 cycles. At 4, 24, and 48 hours after each infusion, they will have whole body scans. These scans will show where the study drug went in their body.\n\nFollow-up visits will continue up to 6 years after the last treatment.",[60,61,25,24,62,63,64,65,66,67],"Sinonasal Neuroendocrine Carcinoma","Nasopharyngeal Carcinoma","Somatostatin Receptor Positive","Small Cell Lung Cancers","Pheochromocytoma\u002FParagangliomas","Kidney Cancers","Head and Neck Tumors","Gastrointestinal Neuroendocrine Tumors",[69,70,71,72],"212Pb","Targeted alpha Therapy","Image-Guided Dosimetry","VMT-alpha-NET","2026-06-11",{"date":75,"type":36},"2026-06-12",{"date":77,"type":36},"2025-08-19",{"date":79,"type":20},"2032-01-01",{"name":42,"class":43},{"id":82,"slug":83,"hasResults":11,"nctId":84,"briefTitle":85,"officialTitle":86,"acronym":87,"eligibilityCriteria":88,"healthyVolunteers":11,"sex":15,"minAge":52,"maxAge":4,"enrollmentInfo":89,"targetDuration":4,"studyType":55,"phases":91,"briefSummary":93,"conditions":94,"keywords":95,"overallStatus":32,"whyStopped":4,"lastUpdateSubmitDate":97,"lastUpdatePostDateStruct":98,"startDateStruct":100,"completionDateStruct":102,"leadSponsor":104,"locationsCount":44},"100535698","phase-2-efficacy-and-safety-of-induction-chemotherapy-for-olfactory-neuroblastoma-esicon-100535698","NCT06255210","Efficacy and Safety of Induction Chemotherapy for Olfactory Neuroblastoma (ESICON)","Efficacy and Safety of Induction Chemotherapy for Olfactory Neuroblastoma: a Prospective Umbrella Clinical Study","ESICON","Inclusion Criteria:\n\n1. Patients with pathologically confirmed olfactory neuroblastoma;\n2. Age ≥ 18 years old;\n3. Dulguerov stage T2-T4;\n4. Patients who signed the informed consent forms;\n5. No distant metastasis.\n\nExclusion Criteria:\n\n1. Patients with uncontrolled concurrent diseases that the researchers believe will interfere with treatment;\n2. Any situation in which the patient may interfere with the compliance or safety during the study;\n3. Severe neurological or mental illness, including dementia and seizures;\n4. Uncontrolled active infection;\n5. Pregnant or lactating women;\n6. Persons without personal freedom and independent capacity for civil conduct;\n7. Other situations that are not suitable for joining the group.",{"count":90,"type":20},25,[92],"PHASE2","The goal of this clinical trial is to learn about the induction chemotherapy efficacy in olfactory neuroblastoma. The main question it aims to answer is: wether olfactory neuroblastoma patients with different pathology subtypes apply to different induction chemotherapy schemes. Participants will be treated with different chemotherapy schemes, to evaluate the tumor remission rate and long term survival.",[24],[96],"Induction Chemotherapy","2024-02-04",{"date":99,"type":36},"2024-02-13",{"date":101,"type":20},"2024-03-01",{"date":103,"type":20},"2030-03-01",{"name":105,"class":106},"Hongmeng Yu","OTHER"]