[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"neuroblastoma-recurrent\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:neuroblastoma-recurrent":26},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,5,0,[8,43,112,134,161],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":4,"eligibilityCriteria":15,"healthyVolunteers":11,"sex":16,"minAge":4,"maxAge":17,"enrollmentInfo":18,"targetDuration":4,"studyType":21,"phases":22,"briefSummary":24,"conditions":25,"keywords":27,"overallStatus":30,"whyStopped":4,"lastUpdateSubmitDate":31,"lastUpdatePostDateStruct":32,"startDateStruct":35,"completionDateStruct":37,"leadSponsor":39,"locationsCount":42},"100599503","phase-2-a-phase-ii-study-with-a-safety-run-in-of-the-addition-of-n-803-to-a-chemoimmunotherapy-backbone-for-the-treatment-of-patients-with-relapsed-or-refractory-neuroblastoma-100599503",false,"NCT07085338","A Phase II Study With a Safety Run-In of the Addition of N-803 to a Chemoimmunotherapy Backbone for the Treatment of Patients With Relapsed or Refractory Neuroblastoma","A Phase II Study With a Safety Run-In of the Addition of N-803, a Novel IL-15 Super-Agonist, to a Chemoimmunotherapy Backbone for the Treatment of Patients With Relapsed or Refractory Neuroblastoma","Inclusion Criteria:\n\nAge\n\n\\- Patients must be \\\u003C 30 at the time of enrollment on study.\n\nDiagnosis\n\n\\- Patients must have had histologic verification of neuroblastoma or demonstration of neuroblastoma cells in the bone marrow with elevated urinary or serum catecholamines \\[i.e., \\> 2 x upper limit of normal (ULN)\\], at the time of initial diagnosis.\n\nDisease Risk Group\n\n* Patients must have high-risk neuroblastoma according to COG risk classification at the time of study registration. Patients whose disease was initially considered low or intermediate risk but were then reclassified as high-risk neuroblastoma prior to enrollment are also eligible.\n\nResponse to Prior Therapy (using INRC definitions)\n\n\\- Patients must have at least ONE (recurrent\u002Fprogressive, refractory, or persistent) of the following:\n\n* Recurrent\u002Fprogressive disease after the diagnosis of high-risk neuroblastoma at any time prior to enrollment regardless of response to frontline therapy. (Note that this excludes patients initially considered low or intermediate risk that progressed to high-risk disease but have not progressed after the diagnosis of high-risk neuroblastoma).\n* Refractory disease: A best overall response of no response\u002Fstable disease since diagnosis of high-risk neuroblastoma AND after at least 4 cycles of induction therapy.\n* Persistent disease: A best overall response of partial response since diagnosis of high-risk neuroblastoma AND after at least 4 cycles of induction therapy\n\nSites of Disease\n\n\\- Patients must have at least ONE of the following (lesions may have received prior radiation therapy if they meet the other criteria listed below) based on institutional assessment:\n\nBone Sites\n\n• MIBG avid tumors: patients must meet one of the following criteria:\n\na. Patients with recurrent\u002Fprogressive or refractory disease: i. Must have at least one MIBG avid bone site on planar imaging OR ii. Must have \\> 2 lesions on SPECT\u002FCT. A biopsy is not required unless the above imaging criteria are not met\n\nb. Patients with persistent disease: i. If a patient has 3 or more MIBG avid bone lesions, then no biopsy is required.\n\nii. If a patient has only 1 or 2 MIBG avid bone lesion sites, then biopsy confirmation of neuroblastoma and\u002For ganglioneuroblastoma in at least one MIBG avid site present at the time of enrollment is required. Bone lesions may be biopsied at any time point prior to enrollment.\n\n* For MIBG non-avid tumors, patients must have at least an FDG-PET avid site and meet the following criteria:\n\n  1. Biopsy confirmation of neuroblastoma and\u002For ganglioneuroblastoma at any time prior to enrollment of at least one FDG-PET avid site.\n\n     Bone Marrow\n\n     \\- Any amount of tumor cells in the bone marrow (including neuroblasts, mature and maturing ganglion cells) done at the time of study enrollment based on routine morphology and\u002For immunohistochemistry in at least one sample from bilateral aspirates and biopsies. NOTE: Patients with bone marrow disease only will be eligible if they have more than 5% disease involvement (documented neuroblastoma cells) in at least one sample from bilateral bone marrow biopsies.\n\n     Soft Tissue Sites\n\n     \\- At least one soft tissue lesion that meets criteria for a TARGET lesion as defined by:\n* SIZE: Lesion can be accurately measured in at least one dimension with a longest diameter ≥ 10 mm, or for discrete lymph nodes ≥ 15mm on short axis. Lesions meeting size criteria will be considered measurable.\n* In addition to size, a lesion needs to meet ONE of the following criteria except for patients with parenchymal CNS lesions which will only need to meet size criteria:\n\n  a. For MIBG avid tumors: lesion must be MIBG avid and meet one of the following criteria: i. For patients with recurrent\u002Fprogressive or refractory disease: no biopsy is required ii. For patients with persistent disease:\n* If a patient has 3 or more MIBG avid soft tissue lesions, then no biopsy is required.\n* If a patient has only 1 or 2 MIBG avid soft tissue lesion sites) then biopsy confirmation of neuroblastoma and\u002For ganglioneuroblastoma in at least one MIBG avid site present at the time of enrollment is required. Soft tissue lesions may be biopsied at any time point prior to enrollment.\n\n  b. For MIBG non-avid tumors patient must have at least one FDG avid site and meet the following criteria: i. Biopsy confirmation of neuroblastoma and\u002For ganglioneuroblastoma from a lesion at any time prior to enrollment of at least one FDG-PET avid site.\n\nii. At least one non-target soft tissue lesion that is not measurable but had a biopsy positive for neuroblastoma and\u002For ganglioneuroblastoma at any time prior to enrollment OR is MIBG avid on planar imaging.\n\nPerformance Status\n\n\\- Patients must have Lansky (≤16 years) or Karnofsky (\\>16 years) score of ≥50 (Appendix I).\n\nNote: Patients who are unable to walk because of paralysis, but who are up in a wheelchair, will be considered ambulatory for the purpose of assessing the performance score.\n\nPrior Therapy\n\n\\- Patients must have fully recovered from the acute toxic effects of all prior chemotherapy, immunotherapy, or radiotherapy prior to study registration. Patients must not have received the therapies indicated below within the specified time prior to registration on this study as follows:\n\nTable 2: Prior Therapies List Type of Therapy Specified Time Period Additional Comments Myelosuppressive Chemotherapy ≤ 14 days This includes cytotoxic agents given on a low dose metronomic regimen as well as retinoids.\n\nBiologic Antineoplastic (anti-neoplastic agents)1 ≤ 7 days Monoclonal Antibodies ≤ 7 days or 3 half-lives whichever is longer, but no longer than 30 days (with recovery of any associated toxicities).\n\nCellular Therapy (e.g., modified T cells, NK cells, dendritic cells, etc.) ≤ 21 days and with recovery of all associated toxicities Radiation Small port radiation ≤ 7 days Large field radiation therapy ≤ 12 weeks i.e., total body irradiation, craniospinal, whole abdominal, total lung, \\> 50% marrow space Other Substantial Bone Marrow Radiation ≤ 6 weeks 131I-MIBG therapy ≤ 6 weeks Hematopoietic Stem Cell Transplant Autologous Stem Cell Infusion Following Myeloablative Therapy ≤ 6 weeks Patients who have received an autologous stem cell infusion to support non-myeloablative therapy (such as 131I-MIBG) are eligible at any time as long as they meet the other criteria for eligibility.\n\nAny other investigational agents (covered under another IND) ≤ 14 days\n\n1. Anti-cancer agents not known to be myelosuppressive (e.g., not associated with reduced platelet or ANC counts)\n\n   Concomitant Therapy Restrictions\n\n   \\- Patients must not have received the concomitant medications indicated below within the specified time prior to study enrollment or planned treatment start date on this study as follows:\n\n   • No other anti-cancer agents or radiotherapy at the time of study registration or while on study.\n\n   • No short-acting hematopoietic growth factors within 7 days of blood draw documenting eligibility and no long-acting hematopoietic growth factors within 14 days of blood draw documenting eligibility.\n\n   • Patients must not have received 0.5 mg\u002Fkg\u002Fday (prednisone equivalent) doses of systemic steroids for at least 7 days prior to study enrollment.\n\n   • Inhaled steroids are permitted to treat reactive airways\n\n   • \\\u003C 2mg\u002Fkg of hydrocortisone or equivalent is permitted as blood product premedication to avoid allergic reactions.\n\n   • Physiologic hydrocortisone dosing is permitted for patients with known adrenal insufficiency.\n   * The use of dexamethasone as an antiemetic is not permitted.\n   * Irinotecan is a substrate for CYP3A4 (major) and CYP2B6 (major). Patients who have received drugs that are strong inducers or inhibitors of CYP3A4 within 7 days prior to study enrollment are not eligible. The use of strong inducers or inhibitors of CYP3A4 (Appendix II) and CYP2B6 (e.g., carbamazepine) should be avoided for the duration of protocol therapy. Consult drug information references for further information. In addition, concomitant use of BCRP inhibitors (cyclosporine, eltrombopag, gefitinib), and UGT1A1 inhibitors (diclofenac, ketoconazole, probenecid, silibinin, nilotinib, and atazanavir) should be avoided due to potential increased risk of irinotecan toxicity.\n\n     * Moderate inducers or inhibitors of CYP3A4 (Appendix II) should also be avoided during protocol therapy if reasonable alternatives exist.\n\n   Organ Function Requirements\n\n   Hematologic Function:\n\n   \\- Patients must meet the following hematologic criteria for enrollment regardless of bone marrow disease involvement:\n   1. ANC ≥750\u002FμL, (no short-acting hematopoietic growth factors ≤ 7 days of blood draw documenting eligibility and no long-acting hematopoietic growth factors ≤ 14 days of blood draw documenting eligibility); and\n   2. Platelet count ≥ 75,000\u002FμL, transfusion independent (no platelet transfusions ≤ 7 days of blood draw documenting eligibility).\n\n   Renal Function\n\n   a. Patients must have adequate renal function defined as age-adjusted serum creatinine ≤1.5 ULN for age (see below):\n\n   Table 3: Age-Adjusted Serum Creatinine Age Maximum Serum Creatine (mg\u002FdL) Male Female\n\n1 to \\\u003C 2 years 0.6 0.6 2 to \\\u003C 6 years 0.8 0.8 6 to \\\u003C 10 years 1 1 10 to \\\u003C 13 years 1.2 1.2 13 to \\\u003C 16 years 1.5 1.4 \\> 16 years 1.7 1.4\n\nLiver Function\n\n1. Total bilirubin ≤ 1.5 x ULN for age; and,\n2. SGPT (ALT) ≤ 225 U\u002FL (≤ 5x ULN). Note that for ALT, the upper limit of normal for all sites is defined as 45 U\u002FL.\n\nCardiac Function\n\n1. Shortening fraction of ≥ 27% by ECHO, or\n2. Ejection fraction of ≥ 50% by ECHO or gated radionuclide study.\n\nPulmonary Function\n\nNo evidence of dyspnea at rest, no exercise intolerance.\n\nAdequate Central Nervous System Function\n\n1. Patients with a history of CNS disease must have no clinical or radiological evidence of active CNS disease at the time of study enrollment\n2. Patients with seizure disorders may be enrolled if seizures are well controlled on anti-seizure medications\n3. CNS toxicity ≤ Grade 2\n\n   Reproductive Function\n\n   \\- All post-menarchal females must have a negative serum or urine beta-HCG ≤ 7 days prior to registration. Male and female subjects of reproductive age and childbearing potential must agree to use two acceptable methods of birth control (i.e., intra-uterine device, diaphragm with spermicide, condom with spermicide, or abstinence) or to abstain from heterosexual intercourse for the duration of their participation in the study.\n\n   Central Nervous System (CNS)\n\n   \\- Patients with a history of intraparenchymal or leptomeningeal based CNS disease must have no clinical or radiological evidence of active CNS disease at the time of study enrollment.\n\n   \\- Patients with skull-based tumors with direct intracranial extension are eligible if there are no neurologic signs or symptoms related to the lesion.\n\n   Exclusion Criteria:\n\n   \\- Pregnancy, breast feeding, or unwillingness to use effective contraception during the study will not be entered on this study due to risks of fetal and teratogenic adverse events. Females of childbearing potential must have a negative pregnancy test to be eligible for this study.\n\n   \\- Patients who, in the opinion of the investigator, may not be able to comply with the safety monitoring requirements of the study.\n\n   \\- Patients with disease of any major organ system that would compromise their ability to withstand therapy.\n\n   \\- Patients who have undergone a prior allogeneic stem cell or solid organ transplant.\n\n   \\- Patients who are on hemodialysis.\n\n   \\- Patients with an active or uncontrolled infection. Patients on prolonged antifungal therapy are still eligible if they are culture negative, afebrile, and meet other organ function criteria.\n\n   \\- Known history of human immunodeficiency virus (HIV) infection, hepatitis B, or hepatitis C. Testing is not required in the absence of clinical findings or suspicions.\n\n   \\- Patients who require or are likely to require pharmacologic doses of systemic corticosteroids while receiving treatment on this study are ineligible. The only exception is for patients known to require 2 mg\u002Fkg or less of hydrocortisone (or an equivalent dose of an alternative corticosteroid) as premedication for blood product administration in order to avoid allergic transfusion reactions. The use of conventional doses of inhaled steroids for the treatment of reactive airway disease is permitted, as is the use of physiological doses of steroids for patients with known adrenal insufficiency.\n\n   \\- Patients on any other immunosuppressive medications (e.g., cyclosporine, tacrolimus) are not eligible.\n\n   \\- Patients must not have received enzyme-inducing anticonvulsants including phenytoin, phenobarbital, or carbamazepine for at least 7 days prior to study enrollment. Patients receiving non-enzyme inducing anticonvulsants such as gabapentin, valproic acid, or levetiracetam will be eligible.\n\n   \\- Patients who have received drugs that are strong inducers or inhibitors of CYP3A4 within 7 days prior to study enrollment are not eligible.\n\n   \\- Patients must not have been diagnosed with myelodysplastic syndrome or with any malignancy other than neuroblastoma.\n\n   \\- Patients with symptoms of congestive heart failure are not eligible.\n\n   \\- Patients must not have \\> Grade 2 diarrhea.\n\n   \\- Patients with a history of progressive disease while receiving therapy per ANBL1221 (irinotecan\u002Ftemozolomide\u002Fdinutuximab\u002FGMCSF).\n\n   \\- Patients with a history of Grade 4 allergic reactions to anti-GD2 antibodies or reactions that required permanent discontinuation of the anti-GD2 therapy are not eligible.\n\n   \\- Patients with elevated catecholamines (i.e., \\> 2 x ULN) only and no evidence of disease are NOT eligible for this study.","ALL","30 Years",{"count":19,"type":20},54,"ESTIMATED","INTERVENTIONAL",[23],"PHASE2","The study participant is being asked to take part in this research study because the participant has been diagnosed with neuroblastoma that did not fully respond to previous treatment (refractory), or it has returned after treatment (relapsed).\n\nPrimary Aims\n\n* To evaluate if the administration of N-803 in combination with irinotecan, temozolomide, hu14-18K322A, and GM-CSF in patients with relapsed\u002Frefractory neuroblastoma is feasible and tolerable\n* To determine if the response rate of N-803 with irinotecan, temozolomide, hu14.18K322A and GM-CSF in patients with relapsed\u002Frefractory neuroblastoma is superior to the combination of irinotecan, temozolomide, hu14.18K322A, and GM-CSF\n\nSecondary Aims\n\n* To describe the toxicity profile of N-803 administered with irinotecan, temozolomide, hu14.18K322A and GM-CSF\n* To evaluate and compare the progression free survival (PFS) and overall survival (OS) of and between patients receiving irinotecan, temozolomide, hu14.18K322A and GM-CSF with and without N-803",[26],"Neuroblastoma Recurrent",[28,29],"relapse","refractory","RECRUITING","2026-06-03",{"date":33,"type":34},"2026-06-04","ACTUAL",{"date":36,"type":34},"2025-11-10",{"date":38,"type":20},"2029-02-01",{"name":40,"class":41},"St. Jude Children's Research Hospital","OTHER",4,{"id":44,"slug":45,"hasResults":11,"nctId":46,"briefTitle":47,"officialTitle":48,"acronym":49,"eligibilityCriteria":50,"healthyVolunteers":11,"sex":16,"minAge":51,"maxAge":4,"enrollmentInfo":52,"targetDuration":4,"studyType":21,"phases":54,"briefSummary":56,"conditions":57,"keywords":79,"overallStatus":30,"whyStopped":4,"lastUpdateSubmitDate":103,"lastUpdatePostDateStruct":104,"startDateStruct":105,"completionDateStruct":107,"leadSponsor":109,"locationsCount":111},"100562786","phase-1-study-in-children-and-adolescents-of-177lu-dotatate-lutathera-combined-with-the-parp-inhibitor-olaparib-for-the-treatment-of-recurrent-or-relapsed-solid-tumours-expressing-somatostatin-receptor-sstr-luparped-100562786","NCT06607692","Study in Children and Adolescents of 177Lu-DOTATATE (Lutathera®) Combined With the PARP Inhibitor Olaparib for the Treatment of Recurrent or Relapsed Solid Tumours Expressing Somatostatin Receptor (SSTR) (LuPARPed).","Single-arm Open-label Phase I\u002FII Study in Children and Adolescents of 177Lu-DOTATATE (Lutathera®) Combined With the PARP Inhibitor Olaparib for the Treatment of Recurrent or Relapsed Solid Tumours Expressing Somatostatin Receptor (SSTR) (LuPARPed).","LUPARPED","Inclusion criteria:\n\n* 18 months - 18 years of age at the time of the initial diagnosis.\n* ≥ 3 years at the moment of inclusion in the trial.\n* Diagnosis: relapsed\u002Frefractory solid tumours with positive uptake on SSTR-PET (PET-CT or PET-MRI), performed in the previous three months before entering the study.\n\nThe evaluation of SSTR expression will be classified according to a qualitative 4-point scale: SSTR expression V (visual score):\n\n* Score = 0: Below or equal to blood pool\n* Score = 1: Above blood pool and lower than liver\n* Score = 2: Equal to or above liver and lower than spleen\n* Score = 3: Equal to or above spleen\n\nPatients with scores ≥ 2 in the majority of the tumoral lesions will be considered to have a positive SSTR-PET and will be therefore eligible for the trial. Patients with a higher score are presumed to have a better response to the treatment.\n\nIt is admissible to have non-measurable disease only (e.g., HR-NB with bone-only or bone-marrow-only active disease).\n\n* Performance status ≥ 50% according to Lansky scale (\\\u003C16 years old) or Karnofsky scale (for ≥16 years old).\n* Life expectancy of at least 3 months.\n* Availability of ability to swallow tablets or capsules.\n* Adequate organ function within 28 days prior to enrolment, as defined by:\n\n  * Hb ≥10 g\u002Fdl (packed red blood transfusion is acceptable up to 24 hours prior starting treatment);\n  * White blood cell (WBC) count ≥ 2500\u002FμL (equivalent to 2.5 x 109\u002FL)\n  * Absolute Neutrophil Count (ANC) ≥ 1000\u002Fμl;\n  * Platelets ≥ 100.000\u002Fμl, without transfusion in the prior ≥7 days;\n  * Serum plasma creatinine ≤ 1.5 x upper limit of normal (ULN) OR estimated glomerular filtration rate (eGFR) ≥ 60 mL\u002Fmin\u002F1.73m2 (assessed by 2009-Schwartz formula).\n  * Total bilirubin ≤ 1.5 x the institutional ULN. For patients with known Gilbert's Syndrome ≤ 3.0 ULN is permitted.\n  * Alanine aminotransferase (ALT) or aspartate aminotransferase (AST) ≤ 3.0 ULN.\n  * Albumin \\>3.0 g\u002FdL (3.0 g\u002FdL is equivalent to 30 g\u002FL)\n* A negative serum or urine pregnancy test in women with onset of menses or ≥12 years of age.\n* Patients of reproductive potential must agree to use highly effective contraceptive methods for the entire study duration and up to 7 months, in case of females, and 4 months in case of males, after the last dose of Lutathera, or up to 6 months, in case of females, and 3 months in case of males, after the last dose of olaparib, whichever takes places later.\n* Have the ability to comprehend and willingness to provide written informed consent (ICF) for the study before patient registration or any trial-related screening procedures. If the patient is \\\u003C18 years old, the written informed consent must be signed by the parent(s) or legal guardian(s) according to national regulations. In the case of patients between 12 and 17 years, they must sign an assent form, and if the patient turns 18 during their participation in the study, they must sign an informed consent form.\n* Adequate recovery from major surgery prior to receiving study treatment.\n* Absence of any psychological, familial, sociological or geographical condition potentially hampering compliance with the study protocol and follow-up schedule; those conditions should be discussed with the patient before registration in the trial.\n\nExclusion criteria\n\n* Previous significant drug-induced hepatitis toxicity experienced in the past that has required treatment dose reductions, treatment discontinuation or that, at the investigator discretion, could infer a risk.\n* Having received more than one previous treatment with other radiolabelled somatostatin analogues.\n* Inability to swallow tablets or capsules.\n* Subjects who are currently receiving any other anticancer and\u002For investigational agents (e.g. chemotherapy, immunotherapy or biological therapy \\[including monoclonal antibodies\\]). There must be at least 28 days of washout from any prior treatment. In case of checkpoints inhibitors, there should be at least 4 months of washout. Palliative Radiation Therapy for symptom control (e.g. pain relief) could be acceptable, at the discretion of the investigator.\n* Treatment with long-acting somatostatin analogues within 28 days prior the administration of 177Lu-DOTATATE.\n* Known hypersensitivity to any of the excipients.\n* Subjects who have an uncontrolled infection.\n* Lactating women.","3 Years",{"count":53,"type":20},25,[55,23],"PHASE1","Study in children and adolescents of 177Lu DOTATATE (Lutathera®) combined with the PARP inhibitor olaparib for treatment of recurrent or relapsed solid tumours expressing somatostatin receptors (SSTR) (LuPARPed)",[58,59,60,61,62,63,64,65,66,67,68,69,70,71,72,73,26,74,75,76,77,78],"Solid Tumor Cancer","Medulloblastoma","High Risk Neuroblastoma","High Grade Gliomas","Meningioma","Paraganglioma","Pheochromocytoma","Neuroendocrine Tumours (NET)","Adrenal Tumours","DIPG","Glioblastoma","Glioblastoma (GBM)","Osteosarcoma Recurrent","Carcinoma Adrenal","Synovial Sarcomas","Esthesioneuroblastoma","Solid Tumor Refractory to Conventional Treatment","Medulloblastoma Recurrent","Paraganglioma\u002F Phaeochromocytoma","Ependymoma","Ependymoma Recurrent",[80,81,82,83,84,85,86,87,88,89,90,91,92,67,93,94,95,96,97,98,99,100,101,77,102],"solid tumours","somatostatin receptors","SSTR","LUTETIUM","OLAPARIB","MEDULLOBLASTOMA","NEUROBLASTOMA","HIGH GRADE GLIOMA","MEININGIOMA","PARAGANGLIOMA","PHEOCHROMOCYTOMA","NEUROENDOCRINE TUMOURS","ADRENAL TUMOR","GLIOBLASTOMA","OSTEOSARCOMA","CARCINOMA ADRENAL","SYNOVIAL SARCOMA","ESTHESIONEUROBLASTOMA","RECURRENT","RELAPSED","RELAPSE","REFRACTORY","Ependimoma Recurrent","2026-06-02",{"date":33,"type":34},{"date":106,"type":34},"2024-09-20",{"date":108,"type":20},"2029-12",{"name":110,"class":41},"Fundación de investigación HM",1,{"id":113,"slug":114,"hasResults":11,"nctId":115,"briefTitle":116,"officialTitle":117,"acronym":4,"eligibilityCriteria":118,"healthyVolunteers":11,"sex":16,"minAge":4,"maxAge":119,"enrollmentInfo":120,"targetDuration":4,"studyType":21,"phases":122,"briefSummary":123,"conditions":124,"keywords":4,"overallStatus":30,"whyStopped":4,"lastUpdateSubmitDate":125,"lastUpdatePostDateStruct":126,"startDateStruct":128,"completionDateStruct":130,"leadSponsor":132,"locationsCount":111},"100497241","phase-2-quadruple-immunotherapy-for-neuroblastoma-100497241","NCT05754684","Quadruple Immunotherapy for Neuroblastoma","Quadruple Immunotherapy for Paediatric Patients With Relapsed or Refractory Neuroblastoma","Inclusion Criteria:\n\n* relapsed or refractory neuroblastoma\n* Adequate organ function: creatinine clearance ≥40 ml\u002Fmin\u002F1.73m2, total bilirubin ≤3 times upper limit of normal and ALT ≤500 IU\u002FL, left ventricular shortening fraction ≥25%, and oxygen saturation ≥92% in room air\n* Karnofsky or Lansky performance status score ≥50\n* Has an appropriate HLA-haploidentical NK-cell donor available\n\nExclusion Criteria:\n\n* Pregnant or lactating woman\n* HIV infection\n* Patients for whom conventional treatment is deemed more appropriate\n* Patients who are unlikely to benefit, e.g., terminal malignancy with life expectancy \\\u003C1 month","18 Years",{"count":121,"type":20},29,[23],"This is a single-arm clinical trial to evaluate the efficacy and safety of quadruple immunotherapy with natural killer (NK) cells, anti-GD2 antibody, cytokines (interleukin-2 (IL-2) and granulocyte-macrophage colony stimulating factor (GM-CSF)) and retinoid X receptor gamma (RXRg) agonist spironolactone for paediatric patients with relapsed or refractory neuroblastoma.",[26],"2025-09-08",{"date":127,"type":34},"2025-09-15",{"date":129,"type":34},"2022-01-01",{"date":131,"type":20},"2025-12-31",{"name":133,"class":41},"Hong Kong Children's Hospital",{"id":135,"slug":136,"hasResults":11,"nctId":137,"briefTitle":138,"officialTitle":138,"acronym":4,"eligibilityCriteria":139,"healthyVolunteers":11,"sex":16,"minAge":140,"maxAge":17,"enrollmentInfo":141,"targetDuration":4,"studyType":21,"phases":143,"briefSummary":144,"conditions":145,"keywords":149,"overallStatus":30,"whyStopped":4,"lastUpdateSubmitDate":151,"lastUpdatePostDateStruct":152,"startDateStruct":154,"completionDateStruct":156,"leadSponsor":158,"locationsCount":160},"100595076","phase-1-feasibility-study-of-prolonged-administration-of-naxitamab-irinotecan-and-temozolomide-for-patients-with-relapsed-or-refractory-neuroblastoma-100595076","NCT07027748","Feasibility Study of Prolonged Administration of Naxitamab, Irinotecan, and Temozolomide for Patients With Relapsed or Refractory Neuroblastoma","Inclusion Criteria:\n\n* Histologic Diagnosis: Patients must have had histologic verification of neuroblastoma or ganglioneuroblastoma or demonstration of neuroblastoma cells in the bone marrow with elevated urinary catecholamines \\[i.e. \\> 2 x upper limit of normal (ULN)\\], at the time of initial diagnosis.\n* Relapsed or Refractory Disease Patients must have ONE of the following:\n\n  * 1\\) Any prior episode of recurrent high-risk disease following completion of frontline high-risk therapy. Patients may have received other lines of therapy for treatment of recurrent disease prior to enrolling to this trial.\n  * 2\\) Prior progressive high-risk disease during frontline high-risk therapy. Patients may have received other lines of therapy for treatment of progressive disease prior to enrolling to this trial.\n  * 3\\) Primary resistant\u002Frefractory disease (less than partial response by INRC) detected after the conclusion of at least 4 cycles of aggressive multidrug induction chemotherapy on or according to a high-risk neuroblastoma protocol (examples include ANBL0532, ANBL09P1, ANBL12P1, ANBL1531, ANBL2131) that was treated with additional therapy with the goal of improving remission status prior to enrolling to this trial.\n* Documentation of Disease: Patients must have at least ONE of the following at the time of enrollment:\n\n  * 1\\) Measurable tumor on MRI or CT scan. Measurable is defined as ≥ 10 mm in at least one dimension (or 15 mm in short axis for lymph node) on spiral\u002Fhelical CT or MRI that is MIBG avid or demonstrates increased FDG uptake on PET scan.\n  * 2\\) MIBG-avid lesion detected on MIBG scan with positive uptake at a minimum of one site. This site must represent disease recurrence or known refractory disease at a site not previously radiated.\n  * 3\\) In patients with known MIBG non-avid disease, FDG-avid lesion detected on FDG- PET scan with positive uptake at a minimum of one site. This site must represent disease recurrence or known refractory disease at a site not previously radiated.\n  * Of note, patients with isolated bone marrow only disease are NOT eligible for this trial.\n* Prior Therapy: Prior lines of anticancer therapy allowed as described in eligibility section above by disease status. Washout periods from prior therapy are as follows:\n\n  * Myelosuppressive chemotherapy: Last dose given 14 days prior to enrollment.\n  * Small molecule targeted therapies (anti-neoplastic agents including retinoids): Last dose given 7 days prior to enrollment.\n  * Monoclonal antibodies: Last given at least 7 days or 3 half-lives, whichever is longer, prior to enrollment.\n  * Radiation:\n\n    * Craniospinal irradiation: Last fraction received minimum of six weeks prior to enrollment\n    * All other radiation: Last fraction received minimum of 14 days prior to enrollment\n  * Hematopoietic stem cell transplant: Date of autologous stem cell infusion following myeloablative chemotherapy must have been a minimum of 12 weeks prior to enrollment. Patients are not eligible post allogeneic stem cell transplant.\n  * Cellular therapies (including CAR-T cells, NK cells, other related cellular therapies): 21 days from the last cellular therapy infusion prior to enrollment and recovery from all associated toxicities\n  * 131I-MIBG therapy: Last therapy received a minimum of 6 weeks prior to enrollment.\n* Age: Patients 1 - 30 years of age at the time of enrollment are eligible for this study.\n* Performance level: Patients must demonstrate adequate performance level as measured by Karnofsky ≥ 70% for patients aged 16 years or older, OR Lansky ≥ 70% for patients younger than 16 years. Please see Appendix A for performance score measurement.\n* Participants must meet the following organ and marrow function as defined below:\n* Adequate bone marrow function as defined as BOTH of the following:\n\n  * Peripheral absolute neutrophil count (ANC) ≥ 750\u002FuL. Must be more than 14 days from last administration of long-acting myeloid stimulating factor (e.g. pegfilgrastim) or 7 days from last administration of short- acting myeloid stimulating factor (e.g. filgrastim or sargramostim)\n  * Peripheral platelet count ≥ 75,000\u002FuL. Must be without support, defined as at least 7 days from last platelet transfusion and\u002For platelet stimulating agent.\n* Adequate renal function as defined as EITHER of the following:\n\n  * Radioisotope GFR ≥ 70ml\u002Fmin\u002F1.73 m2\n  * Serum creatinine based on age\u002Fsex as follows:\n  * Age Maximum Serum Creatinine (mg\u002FdL)\n\n    * 1 to \\\u003C 2 years Male 0.6 Female 0.6\n    * 2 to \\\u003C 6 years Male 0.8 Female 0.8\n    * 6 to \\\u003C 12 years Male 1.0 Female 1.0\n    * 12 to \\\u003C 13 years Male 1.2 Female 1.2\n    * 13 to \\\u003C 16 years Male 1.5 Female 1.4\n\n      ---≥ 16 years Male 1.7 Female 1.4\n    * The threshold creatinine values in this Table were derived from the Schwartz formula for estimating GFR.\n* Adequate liver function defined as ALL of the following:\n\n  * Total bilirubin ≤ 1.5 x ULN for age\\*\n  * ALT ≤ 3.0 x ULN for age (≤ 135 U\u002FL). For the purpose of this study, the ULN for ALT is 45 U\u002FL\n  * Albumin \\> 3 g\u002FdL --\\*If patient has known Gilbert syndrome, direct bilirubin should be used to measure liver function instead of total bilirubin. Direct bilirubin must be within normal limits for age for these patients.\n* Adequate cardiac function measured by echocardiogram as defined as EITHER of the following:\n\n  * Shortening fraction of ≥ 27%\n  * Ejection fraction of ≥ 50%\n* Adequate blood pressure as defined by BOTH of the following:\n\n  * Patients must have \\\u003C Grade 2 hypertension AND\n  * Be on no more than one standing antihypertensive\n* Adequate pulmonary function: Patients must have adequate pulmonary function, defined as:\n\n  * No dyspnea at rest\n  * No exercise intolerance\n  * Room air O2 saturation \\>94%\n  * Not on chronic oxygen therapy\n* Adequate pancreatic function, defined as lipase \\\u003C 1.5 x ULN\n* Able to comply with protocol requirements\n* Adequate contraception: The effects of naxitamab on the developing human fetus are unknown. For this reason and because other therapeutic agents used in this trial are known to be teratogenic, participants with potential to become pregnant or to impregnate a partner must agree to use adequate contraception (hormonal or barrier method of birth control; abstinence) prior to study entry and for the duration of study participation. Should a participant become pregnant or suspect they are pregnant while they or their partner is participating in this study, they should inform the treating physician immediately. Patients treated or enrolled on this protocol must also agree to use adequate contraception prior to the study, for the duration of study participation, and 4 months after completion of protocol therapy.\n* Ability to understand and\u002For the willingness of their parent or legally authorized representative to sign a written informed consent document.\n\nExclusion Criteria:\n\n* Chronic (more than 2 weeks duration) diarrhea \\> grade 1\n* Prior receipt of naxitamab\n* Untreated central nervous system (CNS) metastatic disease\n* Pregnant or currently breast feeding: Pregnant participants are excluded from this study because protocol therapy has the potential for teratogenic or abortifacient effects. Because there is an unknown but potential risk for adverse events in nursing infants secondary to treatment of the parent with protocol therapy, participants planning to continue breastfeeding are excluded from the study.\n* Clinically significant arrhythmias, i.e. those that cause clinical symptoms or require medications for control of symptoms\n* Prior allergic reaction to irinotecan or temozolomide\n* Discontinuation of prior irinotecan or temozolomide due to unacceptable toxicity\n* Discontinuation of prior GD2 directed immunotherapy due to unacceptable toxicity other than allergic reaction\n* Serious intercurrent illness\n* Active uncontrolled infection\n* Existing major organ dysfunction CTCAE \\>Grade 2, except for hearing loss and hematological status, kidney, and liver function as described in eligibility criteria\n* Concomitant Medication Restrictions:\n\n  * Patients may not be receiving immunosuppressive medications including pharmacologic doses of glucocorticoids or immunomodulatory agents due to concern for inhibition of antibody effect. Local and inhaled steroid agents are permitted.\n  * Patients may not be receiving concurrent anti-cancer agents or radiotherapy.\n  * Patients may not have received valproic acid within 14 days prior to enrollment.\n  * Patients may not have received strong CYP3A4 inducers, strong CYP3A4 inhibitors, or strong UGT1A1 inhibitors within 14 days prior to enrollment.\n\n    * Because the lists of these agents are constantly changing, it is important to regularly consult a frequently-updated medical reference. As part of the enrollment\u002Finformed consent procedures, the participant will be counseled on the risk of interactions with other agents, and what to do if new medications need to be prescribed or if the participant is considering a new over-the-counter medicine or herbal product.","1 Year",{"count":142,"type":20},18,[55],"This research is being done to investigate a treatment regimen of Irinotecan, Temozolomide, and Sargramostin, and an immunotherapy called Naxitamab and whether giving Naxitamab more slowly reduces the side effects for participants with relapsed or refractory neuroblastoma.\n\nThe name of the study drugs involved in this study are:\n\n* Naxitamab (A type of monoclonal antibody)\n* Irinotecan (A standard of care chemotherapy)\n* Temozolomide (A standard of care chemotherapy)\n* Sargramostim (A standard of care, granulocyte-macrophage colony stimulating factor)",[146,26,147,148],"Neuroblastoma","Relapsed Neuroblastoma","Refractory Neuroblastoma",[146,26,147,148,150],"Progressive Neuroblastoma","2025-07-11",{"date":153,"type":34},"2025-07-14",{"date":155,"type":34},"2025-06-27",{"date":157,"type":20},"2027-12-01",{"name":159,"class":41},"Steven DuBois, MD",2,{"id":162,"slug":163,"hasResults":11,"nctId":164,"briefTitle":165,"officialTitle":166,"acronym":167,"eligibilityCriteria":168,"healthyVolunteers":11,"sex":16,"minAge":169,"maxAge":4,"enrollmentInfo":170,"targetDuration":4,"studyType":21,"phases":172,"briefSummary":173,"conditions":174,"keywords":4,"overallStatus":30,"whyStopped":4,"lastUpdateSubmitDate":175,"lastUpdatePostDateStruct":176,"startDateStruct":178,"completionDateStruct":180,"leadSponsor":182,"locationsCount":5},"100431883","phase-2-177lutetium-dotatate-in-children-with-primary-refractory-or-relapsed-high-risk-neuroblastoma-100431883","NCT04903899","177Lutetium-DOTATATE in Children With Primary Refractory or Relapsed High-risk Neuroblastoma","A Phase II Trial of 177Lutetium-DOTATATE in Children With Primary Refractory or Relapsed High-risk Neuroblastoma","LuDO-N","Inclusion Criteria:\n\n1. Pathology 1.1. Histologically confirmed diagnosis of neuroblastoma 1.2. Immunohistochemical staining for somatostatin receptors (SSTR) performed from primary tumor tissue when available\n2. Relapsed or primary refractory high-risk neuroblastoma: INSS stage 4 disease or INRGSS stage M disease\n3. Age \\>18 months at the time of enrolment into this study\n4. Life expectancy of greater than 3 months\n5. Performance Status 5.1. Karnofsky \\> 50% (for patients \\> 12 years of age) 5.2. Lansky \\> 50% (for patients ≤ 12 years of age)\n6. Prior treatment 6.1. Two-week washout from any prior treatment 6.2. Patients must have recovery of hematological toxicity following previous therapy 6.3. Adequate recovery from major surgery prior to receiving study treatment\n7. Diagnostic imaging 7.1. Uptake in the primary tumor or metastatic tumour deposits on 68Ga-DOTATATE PET\u002FCT at least higher than the liver uptake and performed within two months prior to registration 7.2. 123I-mIBG scintigraphy to be performed within two months prior to registration 7.3. CT or MRI of the primary tumor and bulky metastatic sites within two months prior to registration\n8. Laboratory requirements to be performed within 7 days prior to commencing trial treatment 8.1. Hematology: 8.1.1. Hemoglobin, If Hb is \\\u003C120 g\u002FL then patient will receive a blood transfusion prior to commencing trial treatment 8.1.2. Absolute neutrophil count \\> 1.0 x 109\u002FL 8.1.3. Absolute Platelets \\> 50 x 109\u002FL 8.2. Biochemistry: 8.2.1. Bilirubin within 1.5 x ULN 8.2.2. ALT within 2.5 x ULN 8.2.3. AST within 2.5 x ULN 8.2.4. GGT within 5 x ULN 8.2.5. ALP within 5 x ULN 8.2.6. Glomerular filtration rate \\>50mL\u002Fmin\u002F1.73m2 assessed by a recognised method, such as inulin, 51Cr-EDTA, 99mTc-DTPA or iohexol clearance and performed within 2 months prior to registration 8.2.7. Urinary catecholamine metabolites measured within 2 months prior to registration\n9. Peripheral blood stem cells (PBSC) 9.1. A minimum of 2 x106 CD34+ cells\u002Fkg (optimally 6 x106 CD34+ cells\u002Fkg) must be available for each study subject prior to registration\n10. Written informed consent from patient and\u002For parent(s) or legal guardian(s) in accordance with national regulations, prior to registration or any trial-related screening procedures\n\nExclusion Criteria:\n\n1. Not fit enough to undergo proposed study treatment, as assessed by national PI, considering precautions defined in the latest version of the 177Lutetium-DOTATATE SmPC.\n2. Pregnant or lactating patient\n3. Concurrent treatment with any anti-tumor agents\n4. Prior treatment with other radiolabeled somatostatin analogues\n5. Hypersensitivity to any component of the investigational drug 177Lutetium-DOTATATE\n6. Treatment with long-acting somatostatin analogues within 30 days, or with short-acting somatostatin analogues within 24 hours prior the administration of 177Lutetium-DOTATATE","18 Months",{"count":171,"type":20},24,[23],"The LuDO-N Trial is a multi-centre phase II clinical trial on 177Lu-DOTATATE treatment of recurrent or relapsed high-risk neuroblastoma in children. The LuDO-N Trial builds on the experience from the previous LuDO Trial and utilises an intensified dosing schedule to deliver 2 doses over a 2-week period, in order to achieve a maximal effect on the often rapidly progressing disease. This strategy requires a readiness for autologous stem cell transplantation in all patients, but is not anticipated to increase the risk of long-term sequelae, since the cumulative radiation dose remains unchanged. The primary aim of the study is to assess the response to 177Lu-DOTATATE treatment at 1 and 4 months after ende of treatment. Secondary aims are to assess survival and treatment-related toxicity. Additional aim are to correlate tumour dosimetry with response, correlate SSTR-2 expression with 68Ga-DOTATATE uptake and to correlate the uptake with the treatment response.",[26,146],"2025-02-07",{"date":177,"type":34},"2025-02-11",{"date":179,"type":34},"2021-05-19",{"date":181,"type":20},"2031-05-20",{"name":183,"class":41},"Jakob Stenman"]