[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"osteosarcoma-recurrent\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:osteosarcoma-recurrent":40},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,3,0,[8,87,117],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":15,"eligibilityCriteria":16,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":19,"targetDuration":4,"studyType":22,"phases":23,"briefSummary":26,"conditions":27,"keywords":50,"overallStatus":74,"whyStopped":4,"lastUpdateSubmitDate":75,"lastUpdatePostDateStruct":76,"startDateStruct":79,"completionDateStruct":81,"leadSponsor":83,"locationsCount":86},"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",false,"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.","ALL","3 Years",{"count":20,"type":21},25,"ESTIMATED","INTERVENTIONAL",[24,25],"PHASE1","PHASE2","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)",[28,29,30,31,32,33,34,35,36,37,38,39,40,41,42,43,44,45,46,47,48,49],"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","Neuroblastoma Recurrent","Solid Tumor Refractory to Conventional Treatment","Medulloblastoma Recurrent","Paraganglioma\u002F Phaeochromocytoma","Ependymoma","Ependymoma Recurrent",[51,52,53,54,55,56,57,58,59,60,61,62,63,37,64,65,66,67,68,69,70,71,72,48,73],"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","RECRUITING","2026-06-02",{"date":77,"type":78},"2026-06-04","ACTUAL",{"date":80,"type":78},"2024-09-20",{"date":82,"type":21},"2029-12",{"name":84,"class":85},"Fundación de investigación HM","OTHER",1,{"id":88,"slug":89,"hasResults":11,"nctId":90,"briefTitle":91,"officialTitle":92,"acronym":4,"eligibilityCriteria":93,"healthyVolunteers":11,"sex":17,"minAge":94,"maxAge":95,"enrollmentInfo":96,"targetDuration":4,"studyType":22,"phases":98,"briefSummary":99,"conditions":100,"keywords":104,"overallStatus":74,"whyStopped":4,"lastUpdateSubmitDate":109,"lastUpdatePostDateStruct":110,"startDateStruct":111,"completionDateStruct":113,"leadSponsor":115,"locationsCount":86},"100604033","phase-1-tegavivint-with-gemcitabine-in-patients-with-relapsed-or-refractory-osteosarcoma-100604033","NCT07144254","Tegavivint With Gemcitabine in Patients With Relapsed or Refractory Osteosarcoma","Study of Tegavivint, a Transducin Beta-like Protein 1 (TBL1) Inhibitor, With Gemcitabine in Patients With Relapsed or Refractory Osteosarcoma","Inclusion Criteria:\n\nDiagnosis:\n\nParticipants must have had histologic verification of osteosarcoma at original diagnosis or relapse.\n\n* All participants with relapsed or refractory osteosarcoma are eligible, provided they received front-line treatment with a regimen that contained at least 3 of the following agents: methotrexate, doxorubicin, cisplatin, and ifosfamide\n\n  -Disease Status:\n* Dose Escalation: Participants must have either measurable or evaluable disease per RECIST.Note: Participants with no evidence of disease on imaging (e.g., following pulmonary metastasectomy) are not eligible during the dose escalation phase.\n* Dose Expansion: Participants with measurable or evaluable disease per RECIST and those with no evidence of disease on imaging following pulmonary metastasectomy are eligible during the dose expansion phase.\n\n  -Performance Level: Participants must have a Lansky (≤ 16 years) or Karnofsky (\\> 16 years) score of ≥ 60, or Eastern Cooperative Oncology Group (ECOG) ≤ 2 Note: Participants who are unable to walk because of paralysis, but who are up in a wheelchair, will be considered ambulatory to assess the performance score.\n\n  -Prior Therapy: Participants must have fully recovered from the clinically significant acute effects of all prior anti-cancer chemotherapy, immunotherapy, surgery, or radiation therapy before enrollment.\n* Myelosuppressive chemotherapy: ≥ 14 days after the last dose.\n* Hematopoietic growth factors: ≥ 14 days after a long-acting growth factor (e.g., pegfilgrastim) or ≥ 7 days for a short-acting growth factor. For agents with known delayed adverse events, extend recovery period accordingly.\n* Biologic (anti-neoplastic) agent: ≥ 7 days after the last dose. Extend period if adverse events occur beyond 7 days.\n* Cellular therapy: ≥ 21 days since last dose (e.g., modified T cells, gamma-delta T cells, natural killer (NK) cells, dendritic cells) with recovery from associated toxicities.\n* Interleukins, interferons, and cytokines (excluding hematopoietic growth factors): ≥ 21 days since last dose.\n* Antibodies: 7 days or 3 half-lives (whichever is longer), up to 30 days. Toxicity must be resolved to Grade ≤ 1.\n* Radiation therapy (XRT):\n\n  * 14 days after local palliative XRT (small port)\n  * 150 days after radiation to ≥ 50% of pelvis or bone marrow\n  * 6 weeks after substantial bone marrow radiation\n\nPrior use of Nucleoside Analogue (Gemcitabine): Allowed. Investigational agents not otherwise specified: ≥ 30 days since last dose. Surgery: ≥ 2 weeks since last major surgery, including pulmonary metastasectomy (central line placement and core\u002Fsmall open biopsies are excluded)\n\nOrgan Function Requirements:\n\n* Adequate Bone Marrow Function Defined As:\n\n  * Peripheral absolute neutrophil count (ANC) ≥ 750\u002Fmm3 (0.75x109\u002FL)\n  * Platelet count ≥ 75,000\u002Fmm3 (75x109\u002FL)\n* Adequate Renal Function Defined As: Creatinine clearance or radioisotope GFR ≥ 70 ml\u002Fmin\u002F1.73 m2\n* Adequate Liver Function Defined As:\n\n  * Bilirubin (sum of conjugated + unconjugated) ≤ 1.5 x the upper limit of normal (ULN) for age\n  * ALT ≤ 5 x the ULN\n* Adequate Pulmonary Function Defined As: No dyspnea at rest, no exercise intolerance, and no oxygen requirement (pulse oximetry \\> 93% on room air).\n* Adequate Cardiac Function Defined As: QTc ≤ 470 ms using Fridericia formula\n\nExclusion Criteria:\n\n* CNS disease: Patients with a history of intraparenchymal CNS disease (osteosarcoma) are not eligible unless they have imaging documenting stability of CNS lesions for ≥ 3 months prior to enrollment\n* Pregnancy or Breast-Feeding\n* Female patients of childbearing potential are not eligible unless a negative pregnancy test result has been obtained\n* Males or females of reproductive potential are not eligible unless they have agreed to use two effective methods of birth control, including a medically accepted barrier or contraceptive method\n* Concomitant Medications:\n\n  * Investigational Drugs: Subjects who are currently receiving another investigational drug are not eligible.\n  * Anti-cancer Agents: Subjects who are currently receiving other anti-cancer agents are not eligible.\n  * CYP3A4\u002F5 Agents: Patients currently receiving drugs that are strong inducers or inhibitors of CYP3A4 are not eligible. Strong inducers or inhibitors of CYP3A4 should be avoided from 14 days before the 1st dose of tegavivint to the end of the study. See Appendix II for a list of agents.\n  * Bisphosphonates: Patients receiving bisphosphonates within 4 Weeks of study enrollment are not eligible.\n  * Denosumab: Patients who have received denosumab within 180 days prior to study enrollment are not eligible\n* Infection: Subjects who have an active, uncontrolled infection.\n* Subjects who have received prior solid organ or allogeneic stem cell transplantation.\n* Subjects who, in the opinion of the investigator, may not be able to comply with the safety monitoring requirements of the study.\n* Patients with a known metabolic bone disease (ex: hyperparathyroidism, Paget's disease, osteomalacia).\n* Patients with a disorder associated with abnormal bone metabolism.\n* Patients with ≥ 2 grade hypocalcemia that is not corrected with oral calcium supplementation.\n* Patients with vitamin D \\\u003C 20 ng\u002FmL will require supplementation or will otherwise be excluded. Patients must agree to take vitamin D +\u002F- calcium supplements (if necessary) according to institutional or published guidelines. Additional calcium supplementation is not required if adequate dietary intake can be ascertained.\n* Patients who have previously received tegavivint are not eligible.","1 Year","30 Years",{"count":97,"type":21},24,[24],"The goal of this clinical trial is to define the maximum tolerated dose (MTD) and\u002For Recommended phase 2 dose (RP2D) of Tegavivint in combination with Gemcitabine in patients with relapsed or refractory osteosarcoma (OS).\n\nThe study will also investigate the toxicities of Tegavivint in combination with gemcitabine in patients with relapsed or refractory OS.",[40,101,102,103],"Osteosarcoma in Children","Relapsed Osteosarcoma","Refractory Osteosarcoma",[105,106,107,108],"Tegavivint","TBL1 inhibitor","Gemcitabine","Osteosarcoma","2026-05-30",{"date":75,"type":78},{"date":112,"type":78},"2026-01-22",{"date":114,"type":21},"2028-05",{"name":116,"class":85},"Emory University",{"id":118,"slug":119,"hasResults":11,"nctId":120,"briefTitle":121,"officialTitle":121,"acronym":122,"eligibilityCriteria":123,"healthyVolunteers":11,"sex":17,"minAge":4,"maxAge":124,"enrollmentInfo":125,"targetDuration":4,"studyType":22,"phases":127,"briefSummary":128,"conditions":129,"keywords":4,"overallStatus":74,"whyStopped":4,"lastUpdateSubmitDate":131,"lastUpdatePostDateStruct":132,"startDateStruct":134,"completionDateStruct":136,"leadSponsor":138,"locationsCount":86},"100584694","phase-1-dfmo-maintenance-for-patients-with-relapsedrefractory-ewing-sarcoma-or-osteosarcoma-100584694","NCT06892678","DFMO Maintenance for Patients With Relapsed\u002FRefractory Ewing Sarcoma or Osteosarcoma","DFMO","Inclusion Criteria:\n\n* Patients \\\u003C 40 years of age at the time of enrollment\n* Diagnosis of relapsed osteosarcoma or relapsed Ewing sarcoma who have completed all planned therapy for their relapse, as described in the protocol, and have no evidence of disease\n* Patients must have a performance status corresponding to Eastern Cooperative Oncology Group (ECOG) scores of 0, 1, or 2\n* Myelosuppressive chemotherapy: At least 14 days must have elapsed since completion of myelosuppressive therapy\n* Monoclonal antibodies: At least 21 days must have elapsed from infusion of last dose of antibody, and toxicity related to prior antibody therapy must be recovered to Grade \\\u003C 2\n* Biologic therapy (defined as anti-cancer agents not known to be myelosuppressive): At least 7 days after the last dose of agent\n* Radiation therapy: At least 14 days must have elapsed after local External Beam Radiation Therapy (XRT), at least 90 days after Total Body Irradiation (TBI), craniospinal XRT or if radiation to greater than 50% of the pelvis, and at least 42 days if other substantial bone marrow radiation\n* Adequate bone marrow function defined as:\n* Peripheral absolute neutrophil count (ANC) greater or equal to 750\u002Fmicroliter\n* Platelet count greater or equal to 75,000\u002Fmicroliter (transfusion independent)\n* Adequate renal function defined by serum creatinine based on age and gender (see protocol)\n* Adequate liver function defined as:\n* Total bilirubin ≤ 1.5 x the upper limit of normal (ULN) for age AND\n* SGPT (ALT) ≤ 5.0 x ULN for age. For this study the ULN is 45 U\u002FL\n\nExclusion Criteria:\n\n* Pregnant or breastfeeding females. Men and women of childbearing potential and their partners must agree to use adequate contraception while enrolled on this study. Based on the teratogenic potential of the agent, pregnant women will be excluded from this study. Because of potential risks to breastfed infants due to drug metabolites that could be excreted in breast milk, female patients who are lactating must agree to stop breastfeeding or will otherwise be excluded from this study. Females of childbearing potential must have a negative pregnancy test to be eligible for this study\n* Patients must not have an uncontrolled infection\n* Patients with a significant intercurrent illness (any ongoing serious medical problem unrelated to cancer or its treatment) that is not covered by the detailed exclusion criteria and that is expected to interfere with the action of study agents or to significantly increase the severity of the toxicities experienced from study treatment are not eligible","39 Years",{"count":126,"type":21},15,[24,25],"The purpose of this study is to determine the feasibility of administering DL-alpha-difluoromethylornithine (DFMO) to patients with relapsed Ewing sarcoma and osteosarcoma who have completed all planned therapy and have no evidence of disease.",[40,130],"Ewing's Tumor Recurrent","2026-05-12",{"date":133,"type":78},"2026-05-14",{"date":135,"type":78},"2025-04-07",{"date":137,"type":21},"2030-04",{"name":139,"class":85},"Montefiore Medical Center"]