[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"leadSponsorName\":\"New Approaches to Neuroblastoma Therapy Consortium\",\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:":92},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,3,0,[8,47,70],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":4,"eligibilityCriteria":15,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":18,"enrollmentInfo":19,"targetDuration":4,"studyType":22,"phases":23,"briefSummary":25,"conditions":26,"keywords":28,"overallStatus":34,"whyStopped":4,"lastUpdateSubmitDate":35,"lastUpdatePostDateStruct":36,"startDateStruct":39,"completionDateStruct":41,"leadSponsor":43,"locationsCount":46},"100550666","phase-2-nant-2021-01-phase-ii-sting-sequential-temozolomide-irinotecan-nk-cells-and-gd2-mab-trial-100550666",false,"NCT06450041","NANT 2021-01 Phase II STING (Sequential Temozolomide, Irinotecan, NK Cells and GD2 mAb) Trial","Phase II Study of Ex-Vivo Expanded Allogeneic Universal Donor TGFβi NK Cell Infusions in Combination With Temozolomide, Irinotecan, Dinutuximab, and Sargramostim in Patients With Relapsed or Refractory Neuroblastoma The STING (Sequential Temozolomide, Irinotecan, NK Cells and GD2 mAb) Trial","Inclusion Criteria:\n\n* Patients must be ≥ 1 year and ≤31 years of age at the time of enrollment on the study.\n* Patients must have a diagnosis of neuroblastoma either by histologic verification of neuroblastoma and\u002For demonstration of tumor cells in the bone marrow with increased urinary catecholamines.\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 then reclassified as high-risk neuroblastoma prior to enrollment also meet this criteria.\n* Patients must have at least ONE of the following:\n\n  1\\) 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\n  2\\) If no prior history of recurrent\u002Fprogressive disease since the diagnosis of high-risk neuroblastoma,\n\n  2a) Refractory disease: A best overall response of no response\u002Fstable disease since diagnosis of high-risk neuroblastoma AND after at least 4 courses of induction therapy.\n\n  2b) Persistent disease: A best overall response of partial response since diagnosis of high-risk neuroblastoma AND after at least 4 courses of induction therapy\n* Patients must have at least ONE of the following (lesions may have received prior radiation therapy as long as they meet the other criteria listed below) based on institutional assessment:\n\n  1\\) Bone Sites\n  1. a) MIBG avid tumors: patients must meet one of the following criteria:\n\n     a. 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 avid bone lesions on SPECT. iii. A biopsy is not required unless the above imaging criteria are not met. b. Patients with persistent disease: i. If a patient has 3 or more MIBG avid sites by planar or SPECT imaging (including soft tissue and\u002For bone), then no biopsy is required.\n\n     ii. If a patient has only 1 or 2 MIBG avid sites by planar or SPECT imaging (including soft tissue and\u002For bone) 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  1b) For MIBG non-avid tumors, patients must have biopsy confirmation of neuroblastoma and\u002For ganglioneuroblastoma from a lesion at any time prior to enrollment of at least one site (with or without FDG-PET uptake).\n\n  2\\) Bone Marrow 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.\n\n  3\\) Soft Tissue Sites\n\n  3a) At least one soft tissue lesion that meets criteria for a TARGET lesion as defined by:\n  1. 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  2. 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     1. For MIBG avid tumors: lesion must be MIBG avid and meet one of the following criteria:\n\n  \u003C!-- -->\n\n  1. For patients with recurrent\u002Fprogressive or refractory disease:\n\n     i. No biopsy is required\n  2. For patients with persistent disease:\n\n     i. If a patient has 3 or more MIBG avid sites by planar or SPECT imaging (including soft tissue and\u002For bone), then no biopsy is required.\n\n     ii. If a patient has only 1 or 2 MIBG avid sites by planar or SPECT imaging (including soft tissue and\u002For bone), 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 biopsy confirmation of neuroblastoma and\u002For ganglioneuroblastoma at any time prior to enrollment from soft tissue lesion (with or without FDG uptake) present at time of enrollment.\n\n  3b) 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* Patients must have a 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\n* Patients must have fully recovered from the acute toxic effects of all prior chemotherapy, immunotherapy, or radiotherapy prior to study registration.\n* Patients must not have received the therapies indicated below after disease evaluation or within the specified time period prior to registration on this study as follows:\n\n  1. Myelosuppressive chemotherapy: must not have received within 2 weeks prior to registration.\n  2. Biologic anti-neoplastics- agents not known to be associated with reduced platelet or ANC counts (including retinoids): must not have received within 7 days prior to registration.\n  3. Monoclonal antibodies: must not have received last dose within 14 days of registration and resolution of all toxicities.\n  4. Cellular Therapy (e.g. modified T cells, NK cells, dentritic cells etc.): must not have received within 3 weeks and resolution of all toxicities.\n  5. Radiation: must not have received small port radiation within 7 days prior to registration, large field radiation within 12 weeks, and 131I-MIBG therapy or other radiopharmaceutical within 6 weeks.\n  6. Hematopoietic Stem Cell Transplant- none following myeloblative therapy within 6 weeks\n  7. Any other investigational agents (covered under another IND within 14 days\n  8. Strong inducers or inhibitors of CYP3A4\n* Hematologic Function:\n\nNOTE: 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\n1. Absolute Neutrophil count ≥750\u002FµL\n2. Platelet count ≥ 75,000\u002FµL, transfusion independent (no platelet transfusions within 7 days of blood draw documenting eligibility)\n\nPatients with known bone marrow metastatic disease will be eligible for study as long as they meet hematologic function criteria above.\n\n* Renal Function Patients must have adequate renal function defined as age-adjusted serum creatinine ≤1.5 ULN for age\n* Liver Function\n\n  1. Total bilirubin ≤ 1.5 x ULN for age; and,\n  2. SGPT (ALT) ≤ 135 U\u002FL (≤ 3x ULN). Note that for ALT, the upper limit of normal for all sites is defined as 45 U\u002FL.\n* Cardiac Function\n\n  1. Normal ejection fraction (≥ 55%) documented by either echocardiogram OR\n  2. Normal fractional shortening (≥ 27%) documented by echocardiogram\n* Pulmonary Function No evidence of dyspnea at rest\n* Reproductive Function All females ≥ Tanner stage 2 and post-menarchal of childbearing potential must have a negative beta-HCG within 7 days prior to study registration. Males and females of reproductive age and childbearing potential must commit to using effective contraception for the duration of their participation.\n* Central Nervous System (CNS) 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\nPatients with skull-based tumors with direct intracranial extension are eligible as long as there are no neurologic signs or symptoms related to the lesion.\n\nExclusion Criteria:\n\n* Patients who are pregnant, breast feeding, or unwilling to use effective contraception during the study\n* Patients who, in the opinion of the investigator, may not be able to comply with the safety monitoring requirements of the study.\n* Patients with disease of any major organ system that would compromise their ability to withstand therapy.\n* Patients with \\> Grade 2 diarrhea.\n* Patients who have undergone a prior allogeneic stem cell or solid organ transplant.\n* Patients who are on hemodialysis.\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* Patients with known history of human immunodeficiency virus (HIV) infection, hepatitis B, or hepatitis C. Testing is not required in the absence of clinical findings or suspicion.\n* Patients must not have been diagnosed with any other malignancy.\n* Patients with history of Grade 4 Allergic reactions to anti-GD2 antibody therapy or reactions that caused permanent discontinuation of therapy.\n* Patients with history of progressive disease while receiving therapy per ANBL1221.\n* Patient declines participation in the NANT biology study and the site has not been granted a waiver from participation.\n* Systemic Steroids and Immunosuppressive Medications\n* Patients who have received pharmacologic doses of systemic steroids 7 days prior to study registration or likely to require them after study registration.\n\nNote: Exceptions are the following:\n\n1. 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.\n2. The use of conventional doses of inhaled steroids for the treatment of asthma\n3. The use of physiologic doses of steroids for patients with known adrenal insufficiency.\n\n   * Patients on any other immunosuppressive medications (e.g., cyclosporine, tacrolimus) at the time of study registration.","ALL","1 Year","31 Years",{"count":20,"type":21},62,"ESTIMATED","INTERVENTIONAL",[24],"PHASE2","This is a phase II study looking at patient response to treatment with the combination dinutuximab, temozolomide, irinotecan, and GM-CSF.",[27],"Neuroblastoma",[29,30,31,32,33],"Relapsed Neuroblastoma","Refractory Neuroblastoma","Cellular Therapy","Immunotherapy","Chemoimmunotherapy","RECRUITING","2026-06-08",{"date":37,"type":38},"2026-06-10","ACTUAL",{"date":40,"type":38},"2024-12-16",{"date":42,"type":21},"2038-12",{"name":44,"class":45},"New Approaches to Neuroblastoma Therapy Consortium","OTHER",13,{"id":48,"slug":49,"hasResults":11,"nctId":50,"briefTitle":51,"officialTitle":52,"acronym":4,"eligibilityCriteria":53,"healthyVolunteers":11,"sex":16,"minAge":54,"maxAge":55,"enrollmentInfo":56,"targetDuration":4,"studyType":58,"phases":4,"briefSummary":59,"conditions":60,"keywords":4,"overallStatus":34,"whyStopped":4,"lastUpdateSubmitDate":61,"lastUpdatePostDateStruct":62,"startDateStruct":64,"completionDateStruct":66,"leadSponsor":68,"locationsCount":69},"100177683","neuroblastoma-biology-study-100177683","NCT01587300","Neuroblastoma Biology Study","N2004-05: Neuroblastoma Biology Study","Inclusion Criteria:\n\n* Patients must be greater than or 31 days of age.\n* Patients must have had a diagnosis of high risk neuroblastoma either by histological verification of neuroblastoma and\u002For demonstration of tumor cells in the bone marrow with increased urinary catecholamines.\n* All patients with refractory or recurrent high risk neuroblastoma at NANT institutions are eligible regardless of disease status (including no measurable or evaluable tumor) as long as they undergo a disease evaluation and appropriate samples are submitted.\n* Additionally, all patients with high risk neuroblastoma without relapse treated at a NANT institution are eligible if undergoing a disease evaluation, as long as Children's Oncology Group specimens are prioritized.\n\nExclusion Criteria:\n\n* There are no exclusion criteria on this study.","31 Days","99 Years",{"count":57,"type":21},1000,"OBSERVATIONAL","Medical scientists want to find better ways to treat neuroblastoma and to find ways to prevent the tumor from growing back. To do this, they need more information about the characteristics of neuroblastoma cells. Therefore, they want to study samples of neuroblastoma tissues and neuroblastoma and normal cells in the blood and bone marrow that may be related to the growth of neuroblastoma cells. Doctors and other medical scientists also want to find better ways to detect and measure neuroblastoma to improve the ability to follow the response of tumor cells to therapy.",[27],"2026-03-19",{"date":63,"type":38},"2026-03-23",{"date":65,"type":4},"2011-07",{"date":67,"type":21},"2099-12",{"name":44,"class":45},17,{"id":71,"slug":72,"hasResults":11,"nctId":73,"briefTitle":74,"officialTitle":75,"acronym":4,"eligibilityCriteria":76,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":77,"enrollmentInfo":78,"targetDuration":4,"studyType":22,"phases":80,"briefSummary":81,"conditions":82,"keywords":4,"overallStatus":83,"whyStopped":4,"lastUpdateSubmitDate":84,"lastUpdatePostDateStruct":85,"startDateStruct":87,"completionDateStruct":89,"leadSponsor":91,"locationsCount":46},"100613027","phase-2-nant-2021-02-randomized-mibg-with-vorinostatdinutuximabvorinostat--dinutuximab-100613027","NCT07261241","NANT 2021-02: Randomized MIBG With Vorinostat\u002FDinutuximab\u002FVorinostat + Dinutuximab","NANT 2021-02: A Randomized Phase 2 Study of 131I-MIBG With Vorinostat VS. 131I-MIBG With Dinutuximab vs. 131I-MIBG With Dinutuximab and Vorinostat for Relapsed or Refractory Neuroblastoma","Inclusion Criteria:\n\nAge Patients must be ≥ 1 year and \\\u003C 30 years of age at the time of study registration.\n\nDiagnosis Patients must have a diagnosis of neuroblastoma or ganglioneuroblastoma nodular subtype either by histologic verification of neuroblastoma and\u002For demonstration of tumor cells in the bone marrow with increased urinary catecholamines.\n\nDisease Risk Group Patients must have high risk neuroblastoma according to COG risk classification at the time of study registration. Patients who were initially considered low or intermediate risk, but then reclassified as high risk are also eligible.\n\nResponse to Prior Therapy (using INRC definitions)\n\nPatients must have at least ONE 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* If no prior history of recurrent\u002Fprogressive disease since 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 courses of induction therapy.\n* Persistent disease: A best overall response of minor response since diagnosis of high risk neuroblastoma AND after at least 4 courses of induction therapy:\n\n  i. If a patient with persistent disease has 3 or more MIBG avid sites (including all soft tissue and\u002For bone lesions) OR a Curie Score of ≥ 3, then no biopsy is required for eligibility.\n\nii. If a patient with persistent disease has only 1 or 2 MIBG avid sites (including all soft tissue and\u002For bone lesions) then biopsy confirmation of neuroblastoma and\u002For ganglioneuroblastoma in at least one MIBG avid site (bone marrow, bone, or soft tissue) present at the time of registration is required. Bone and\u002For soft tissue lesions may be biopsied at any time point prior to study registration, bone marrow must be done at the time of study registration.\n\nSites of Disease: MIBG Uptake Patients must have evidence of MIBG uptake into tumor at ≥ 1 site (bone or soft tissue) within 21 days prior to study entry and subsequent to any intervening therapy. See exclusion criteria.\n\nAutologous peripheral blood stem cells (PBSC)\n\n* The minimum dose for peripheral blood stem cells is 1.5 x 106 viable CD34+ cells\u002Fkg. Patients who do not meet this minimum requirement for available PBSCs are not eligible.\n* Only un-purged stem cells are allowed unless a center has separate FDA approval for infusion of purged stem cells.\n* For patients whose body weight exceeds ideal body weight (IBW) by more than 20%, adjusted body weight may be used for the calculation of PBSC dose.47\n\nPerformance level Patients must have a Lansky (≤ 16 years) or Karnofsky (\\> 16 years) score of ≥ 50 Note: Subjects 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 Patients must have fully recovered from the acute toxic effects of all prior chemotherapy, immunotherapy, or radiotherapy prior to study registration.\n\nOrgan Function Requirements\n\nHematologic Function:\n\nPatients must meet the following hematologic criteria for enrollment regardless of bone marrow disease involvement:\n\n1. ANC ≥750\u002FuL (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\n2. Platelet count ≥ 50,0000\u002Fµl, transfusion independent (no platelet transfusions or platelet growth factors ≤ 7 days of blood draw documenting eligibility).\n\nRenal Function a. Patients must have adequate renal function defined as age-adjusted serum creatinine ≤1.5 ULN for age Liver Function\n\n1. Total bilirubin ≤ 1.5 x ULN for age; and,\n2. SGPT (ALT) ≤ 135 U\u002FL (≤ 3x ULN). Note that for ALT, the upper limit of normal for all sites is defined as 45 U\u002FL.\n\nCentral Nervous System (CNS) Function:\n\n1. 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.\n2. Patients with skull based tumors with direct intracranial extension are eligible as long as there are no neurologic signs or symptoms related to the lesion.\n\nCardiac Function\n\n1. Normal ejection fraction (≥ 55%) documented by either echocardiogram or radionuclide MUGA evaluation OR normal fractional shortening (≥ 27%) documented by echocardiogram.\n2. Corrected QT (QTcF) interval ≤ 480 msec. Pulmonary Function No evidence of dyspnea at rest, no exercise intolerance, or oxygen requirement. Reproductive Function\n\na. All females of childbearing potential (female patients 10 and older without documented ovarian failure) must have a negative serum or urine beta-HCG ≤ 7 days prior to registration.\n\nb. 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, hormonal contraception, diaphragm with spermicide, condom with spermicide, or abstinence) or to abstain from heterosexual intercourse for the duration of their participation in the study, or for 3 months after last dose of protocol therapy, whichever is longer.\n\nExclusion Criteria:\n\nPregnancy, 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.\n\nPatients who, in the opinion of the investigator, may not be able to comply with the safety monitoring or radiation isolation requirements of the study.\n\nPatients with disease of any major organ system that would compromise their ability to withstand therapy.\n\nPatients must not have received prior allogeneic stem cell transplant.\n\nPatients who have received prior solid organ transplantation.\n\nPatients must not have received prior total body irradiation.\n\nPatients who are on hemodialysis.\n\nPatients 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\nKnown history of active human immunodeficiency virus (HIV) infection, hepatitis B, or hepatitis C. Testing is not required in the absence of clinical findings or suspicion.\n\nPatients with a history of having to permanently discontinue anti-GD2 antibody therapy, GM-CSF, or vorinostat due to toxicity are not eligible.\n\nPatients who have received prior MIBG in combination with anti-GD2 monoclonal antibody and\u002For histone deacetylase inhibitor\n\nThe maximum total allowable dose of 131I-MIBG that can be given per institutional guidelines must be at least 90% of the calculated or protocol maximum 131I-MIBG dose or the patient is not eligible.\n\nPatients with a history of deep venous thrombosis that was not associated with the presence of a central venous catheter.\n\nPatient declines participation in NANT 2004-05, the NANT Biology Study.\n\nPatients with evidence of active MIBG non-avid disease; patients with previously treated and stable disease that is not MIBG avid are still eligible.\n\nPatients whose best response post previous MIBG therapy was progressive disease.\n\nPatients with a cumulative lifetime dose of 131I-MIBG greater than 20 mCi\u002Fkg.","30 Years",{"count":79,"type":21},118,[24],"Patients will then be randomized at study entry to one of three treatment arms. Patients on Arm A will receive a single treatment course with 131I-MIBG with vorinostat. Patients on Arm B will receive a single treatment course with 131I-MIBG and dinutuximab. Patients on Arm C will receive a single treatment course with 131I-MIBG with dinutuximab + vorinostat. After this course of treatment, we will check to see your response and then check to see how you are doing over time. All patients may choose to proceed to a second course of the same treatment if they and their physician feel healthy enough to do so. Approximately 118 patients will be receiving therapy on this trial.",[27],"NOT_YET_RECRUITING","2025-11-21",{"date":86,"type":38},"2025-12-03",{"date":88,"type":21},"2026-07-31",{"date":90,"type":21},"2031-07-31",{"name":44,"class":45},""]