[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"osteosarcoma-in-children\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:osteosarcoma-in-children":26},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,4,0,[8,46,79,107],{"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":22,"briefSummary":24,"conditions":25,"keywords":28,"overallStatus":33,"whyStopped":4,"lastUpdateSubmitDate":34,"lastUpdatePostDateStruct":35,"startDateStruct":38,"completionDateStruct":40,"leadSponsor":42,"locationsCount":45},"100636064","phase-2-the-catsindo-trial---clinical-and-translational-study-in-newly-diagnosed-osteosarcoma-100636064",false,"NCT07560826","The CATSINDO Trial - Clinical and Translational Study in Newly Diagnosed Osteosarcoma","Pre-Enrollment Criteria:\n\n1. Suspected diagnosis of high-grade osteosarcoma based on clinical and radiographic findings.\n2. Informed consent (and assent, if applicable) obtained, per institutional guidelines.\n3. Participants must be ≤ 22 years of age at the time of consent.\n\nInclusion Criteria:\n\n1. Participants with localized or metastatic high-grade osteosarcoma.\n2. Participants must be ≤ 22 years of age at the time of consent.\n3. Participants must have a body surface area of greater than or equal to 0.8 m2.\n4. Participants receiving or planning to receive induction\u002Fneoadjuvant MAP chemotherapy with HD-MTX given at the standard dose of 12 gm\u002Fm2 (maximum 20 gm).\n\n   NOTE: Participants may be participating on other clinical studies such as the COG trial AOST2032 or any other clinical trial as long as their treatment includes MAP chemotherapy with the standard HD-MTX dose of 12 gm\u002Fm2 (maximum 20 gm).\n5. Participants may receive other chemotherapy agents in their treatment provided that drug(s) are not known to interfere with HD-MTX clearance when given concurrently. Medications known to interfere with HD-MTX clearance are listed in Appendix A.\n6. Participants must meet minimum organ function requirements to receive HD-MTX:\n\n   * Adequate liver function defined as: total bilirubin ≤ 1.5x upper limit of normal (ULN) for age at the time of consent and alanine aminotransferase (ALT\u002FSGPT) ≤ 135 U\u002FL for age at the time of consent.\n   * Adequate renal function defined as: a serum creatinine based on age\u002Fgender OR - a 24-hour urine Creatinine clearance ≥ 70 mL\u002Fmin\u002F1.73 m2, OR - an estimated glomerular filtration rate (GFR) of greater than or equal to 70 mL\u002Fmin\u002F1.73 m2 for age at the time of consent.\n   * Adequate bone marrow function defined as: peripheral absolute neutrophil count (ANC) ≥ 1000\u002FµL, platelet count ≥ 100,000\u002FµL (transfusion independent, defined as not receiving platelet transfusions within a 7-day period prior to enrollment), and hemoglobin ≥ 8.0 g\u002FdL (transfusion independent, defined as not receiving red blood cell transfusions within a 7-day period prior to enrollment)\n7. Adequate cardiac function, defined as a left ventricular ejection fraction (LVEF) ≥ 50%, assessed per institutional standard of care using non-invasive imaging modalities such as a Multi-Gated Acquisition (MUGA) scan or echocardiogram (echo).\n\n   NOTE: Cardiac function assessment will be performed as part of routine clinical care. No additional imaging or procedures will be mandated by the research protocol.\n8. Informed consent, and assent when appropriate, must be obtained, per institutional guidelines.\n9. Participants can enroll after initiation of induction MAP chemotherapy so long as they are enrolled prior to the second cycle of chemotherapy (prior to week 6 cisplatin and doxorubicin).\n10. Participants must be willing and able to comply with all study procedures for the entire length of the study.\n\nExclusion Criteria:\n\n1. Female participants who are pregnant and\u002For lactating and breast feeding their infant(s).\n\n   NOTE: Pregnancy testing will follow institutional standard of care practice and is not mandated by the protocol.\n2. Sexually active participants of reproductive potential who have not agreed to use an effective contraceptive method for the duration of protocol therapy, at the discretion of the investigator.","ALL","7 Years","22 Years",{"count":19,"type":20},46,"ESTIMATED","INTERVENTIONAL",[23],"PHASE2","The goal of this study is to learn whether children, adolescents, and young adults with newly diagnosed high-grade osteosarcoma can be safely discharged from the hospital at slightly higher methotrexate blood levels after receiving standard high-dose methotrexate chemotherapy. Participants are 22 years old or younger and are receiving standard MAP (high-dose methotrexate with doxorubicin and cisplatin) chemotherapy as part of their routine cancer treatment.\n\nThe main questions this study aims to answer are:\n\n* Is hospital discharge at higher methotrexate levels safe, based on side effects or hospital re-admission within 7 days?\n* Can patient-derived osteosarcoma tumor organoids be successfully generated across multiple centers?\n\nResearchers will compare safety outcomes and hospital length of stay to historical patient data discharged at lower methotrexate levels.\n\nParticipants will receive standard chemotherapy, meet study-defined discharge criteria, be monitored for side effects, and have the option to provide tumor and blood samples for future research.",[26,27],"Osteosarcoma in Children","Osteosarcoma in Adolescents and Young Adults",[29,30,31,32],"Osteosarcoma","CATSINDO","Organoids","Interventional","NOT_YET_RECRUITING","2026-06-24",{"date":36,"type":37},"2026-06-25","ACTUAL",{"date":39,"type":20},"2026-08",{"date":41,"type":20},"2028-12",{"name":43,"class":44},"Wake Forest University Health Sciences","OTHER",8,{"id":47,"slug":48,"hasResults":11,"nctId":49,"briefTitle":50,"officialTitle":51,"acronym":4,"eligibilityCriteria":52,"healthyVolunteers":11,"sex":15,"minAge":53,"maxAge":54,"enrollmentInfo":55,"targetDuration":4,"studyType":21,"phases":57,"briefSummary":59,"conditions":60,"keywords":64,"overallStatus":68,"whyStopped":4,"lastUpdateSubmitDate":69,"lastUpdatePostDateStruct":70,"startDateStruct":72,"completionDateStruct":74,"leadSponsor":76,"locationsCount":78},"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":56,"type":20},24,[58],"PHASE1","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.",[61,26,62,63],"Osteosarcoma Recurrent","Relapsed Osteosarcoma","Refractory Osteosarcoma",[65,66,67,29],"Tegavivint","TBL1 inhibitor","Gemcitabine","RECRUITING","2026-05-30",{"date":71,"type":37},"2026-06-02",{"date":73,"type":37},"2026-01-22",{"date":75,"type":20},"2028-05",{"name":77,"class":44},"Emory University",1,{"id":80,"slug":81,"hasResults":11,"nctId":82,"briefTitle":83,"officialTitle":84,"acronym":4,"eligibilityCriteria":85,"healthyVolunteers":11,"sex":15,"minAge":86,"maxAge":87,"enrollmentInfo":88,"targetDuration":4,"studyType":90,"phases":4,"briefSummary":91,"conditions":92,"keywords":94,"overallStatus":68,"whyStopped":4,"lastUpdateSubmitDate":97,"lastUpdatePostDateStruct":98,"startDateStruct":100,"completionDateStruct":102,"leadSponsor":104,"locationsCount":106},"100588013","tissue-expression-of-krppel-like-factors-4-and-7-in-bone-tumors-100588013","NCT06935864","Tissue Expression of Krüppel-Like Factors 4 and 7 in Bone Tumors","The Prognostic Value of Tissue Expression of Krüppel-Like Factors 4 and 7 in Bone Tumors","Inclusion Criteria:\n\nAge: children, young adolescents younger than 15 years, and young adults (15 to 39 years) Gender: Males and female. Histologically confirmed patients with skeletal or extra-skeletal OS or ES. Both localized and metastatic disease stages.\n\nExclusion Criteria:\n\nPatients with second malignant bone sarcoma. Patients with benign bone tumors.","1 Month","39 Years",{"count":89,"type":20},30,"OBSERVATIONAL","The current study is to assess the prognostic value of Krüppel-like factors 4 and 7 in bone tumors, and its role in the disease progression.",[26,93],"Ewing Sarcoma of Bone or Soft Tissue",[95,29,96],"Bone Tumor","Ewing sarcoma","2025-04-12",{"date":99,"type":37},"2025-04-20",{"date":101,"type":37},"2024-08-16",{"date":103,"type":20},"2026-02",{"name":105,"class":44},"Ain Shams University",2,{"id":108,"slug":109,"hasResults":11,"nctId":110,"briefTitle":111,"officialTitle":111,"acronym":112,"eligibilityCriteria":113,"healthyVolunteers":11,"sex":15,"minAge":114,"maxAge":4,"enrollmentInfo":115,"targetDuration":4,"studyType":21,"phases":117,"briefSummary":118,"conditions":119,"keywords":4,"overallStatus":68,"whyStopped":4,"lastUpdateSubmitDate":120,"lastUpdatePostDateStruct":121,"startDateStruct":123,"completionDateStruct":125,"leadSponsor":127,"locationsCount":78},"100566079","phase-2-a-phase-2-pilot-study-to-evaluate-the-safety-and-the-anti-tumour-activity-of-the-myc-inhibitor-omo-103-administered-intravenously-in-patients-with-advanced-high-grade-osteosarcoma-100566079","NCT06650514","A Phase 2 Pilot Study to Evaluate the Safety and the Anti-Tumour Activity of the Myc Inhibitor OMO-103 Administered Intravenously in Patients With Advanced High-Grade Osteosarcoma","Osteomyc","Inclusion Criteria:\n\n1. Provision of signed and dated informed consent form.\n2. Age ≥12 years at time of informed consent.\n3. Histologically proven, advanced high-grade osteosarcoma not suitable for local treatments with curative intent\n4. Confirmed disease progression by radiological report to at least one line of standard chemotherapy containing cisplatin and anthracycline, and no more than 2 previous lines.\n5. Measurable disease as per RECIST v1.1 criteria and documented by CT\u002FMRI (Appendix 1 - RECIST Response Criteria). NOTE: Lesions to be used as measurable disease for the purpose of response assessment must either:\n\n   1. not reside in a field that has been subjected to prior radiotherapy, or\n   2. have demonstrated clear evidence of radiographic progression since the completion of prior radiotherapy and prior to study enrolment.\n6. Provision of a newly obtained tumour biopsy (either from the primary tumour or from metastases) during screening and on-treatment from all patients \\>16 years of age. Notes:\n\n   * The identified lesion to be biopsied should not have been previously irradiated and should not be the only lesion being used as a measurable-disease target lesion for objective response assessment. Patients must have tumour lesions that can be accessible for biopsy with acceptable clinical risk in the judgement of the Investigator.\n   * In case a patient has had a tumour biopsy in the previous 6 months and a paraffin block is available, a new biopsy does not need to be done at Screening (if they have received no treatment after biopsy).\n7. Documented progression on or following the last line of therapy.\n8. ECOG performance status 0-2 (Appendix 2 - Performance Status Criteria).\n9. Life expectancy of ≥ 12 weeks as estimated by the treating physician.\n10. Resolution of all acute, reversible toxic effects of prior therapy or surgical procedure to Grade ≤1 (except alopecia and peripheral neuropathy to Grade ≤2).\n11. Adequate organ function.\n12. If not postmenopausal or surgically sterile, female patients and female sexual partners of male patients must be willing to use at least one highly effective method of birth control (hormonal contraception, IUD, abstinence, condom) for at least a menstrual cycle before and for 3 months after last study drug administration.\n\nExclusion Criteria:\n\n1. Treatment with systemic anti-cancer therapy within three weeks prior to study drug administration for chemotherapy and 5 half-lives for targeted therapies.\n2. Radiation therapy within four weeks prior to study entry. Localised palliative radiotherapy to nontarget lesions is allowed\n3. Low-grade osteosarcoma, parosteal, or periosteal osteosarcoma.\n4. Prior history of other malignancies other than osteosarcoma (except for basal cell or squamous cell carcinoma of the skin or carcinoma in situ of the cervix) unless the patient has been free of the disease for at least 2 years.\n5. Non-malignant systemic disease including cerebrovascular accident, unstable angina pectoris, unstable atrial fibrillation, unstable cardiac arrhythmia, myocardial infarction in the last six months, New York Heart Association (NYHA) Class III or IV heart failure (Appendix 5 - New York Heart Association Criteria).\n6. Patients with active uncontrolled infection or known to be serologically positive for human immunodeficiency virus (HIV), hepatitis B (except after vaccination) or hepatitis C infection. Investigators may test as per their discretion.\n7. Other severe acute or chronic medical or psychiatric condition or laboratory abnormality that may increase the risk associated with study participation or investigational product administration or may interfere with the interpretation of study results and, in the judgment of the Investigator, would make the patient inappropriate for entry into this study.\n8. Patients with symptomatic or unstable central nervous system primary tumour or metastases and\u002For sarcomatous meningitis\n9. Live vaccine in the last four weeks.\n10. Current participation in another interventional therapeutic trial.\n11. Is pregnant or breastfeeding or expecting to conceive or father children within the projected duration of the study.\n12. Knowledge of any other disease or medication that may interfere with study treatment.\n13. Patients with known allergies or hypersensitivity reactions to the active substance or to any of its excipients\n14. Patient unable to comply with the study protocol owing to psychological, social (lack of social support or social exclusion) or geographical reasons.","12 Years",{"count":116,"type":20},10,[23],"This is an open-label, unicentric, single-arm Phase 2 pilot study to serve as a proof-of-concept of OMO-103 safety and activity in patients with advanced high-grade osteosarcoma.\n\nPatients will be treated at the RP2D (6.5 mg\u002Fkg as a weekly IV infusion) of OMO-103 to estimate anti-tumour activity and further characterise the safety, tolerability, PK, and PD of OMO-103 in advanced high-grade osteosarcoma patients. Ten (10) evaluable patients will be enrolled. At least 30% of patients will be \\\u003C18 years old. The first three patients 12-15 years of age will undergo additional safety monitoring.\n\nPatients will be treated until progression by RECIST v1.1 or intolerable toxicity.",[29,26],"2025-01-08",{"date":122,"type":37},"2025-01-10",{"date":124,"type":37},"2024-12-27",{"date":126,"type":20},"2026-12",{"name":128,"class":44},"Vall d'Hebron Institute of Oncology"]