[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"embryonal-rhabdomyosarcoma\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:embryonal-rhabdomyosarcoma":26},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,3,0,[8,42,107],{"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":4,"overallStatus":29,"whyStopped":4,"lastUpdateSubmitDate":30,"lastUpdatePostDateStruct":31,"startDateStruct":34,"completionDateStruct":36,"leadSponsor":38,"locationsCount":41},"100462662","phase-3-chemotherapy-for-the-treatment-of-patients-with-newly-diagnosed-very-low-risk-and-low-risk-fusion-negative-rhabdomyosarcoma-100462662",false,"NCT05304585","Chemotherapy for the Treatment of Patients With Newly Diagnosed Very Low-Risk and Low Risk Fusion Negative Rhabdomyosarcoma","A Prospective Phase 3 Study of Patients With Newly Diagnosed Very Low-Risk and Low-Risk Fusion Negative Rhabdomyosarcoma","Inclusion Criteria:\n\n* All patients must be enrolled on APEC14B1 (NCT02402244) and consented to the Molecular Characterization Initiative (Part A) prior to enrollment and treatment on ARST2032 (this trial).\n* Patients must be =\\\u003C 21 years at the time of enrollment.\n* Patients must have newly diagnosed embryonal rhabdomyosarcoma (ERMS), spindle cell\u002Fsclerosing RMS, or FOXO1 fusion negative alveolar rhabdomyosarcoma (ARMS) (institutional FOXO1 fusion results are acceptable). RMS types included under ERMS include those classified in the 1995 International Classification of Rhabdomyosarcoma (ICR) as ERMS (classic, spindle cell, and botryoid variants), which are reclassified in the 2020 World Health Organization (WHO) classification as ERMS (classic, dense and botryoid variants) and spindle cell\u002Fsclerosing RMS (encompassing the historical spindle cell ERMS variant and the newly recognized sclerosing RMS variant). Enrollment in APEC14B1 is required for all patients.\n\n  * All patients will be evaluated for stage and clinical group. Note that clinical group designation assigned at the time of enrollment on study remains unchanged regardless of any second-look operation that may be performed.\n\n    * Patients will be eligible for the very low-risk stratum (Regimen VA) if they have Stage 1, CG I disease.\n    * Patients will be eligible for the low-risk stratum (Regimen VAC\u002FVA) if they have Stage 1, CG II disease, Stage 2, CG I or II disease, or Stage 1, CG III (orbit only) disease.\n  * Paratesticular Tumors: Staging ipsilateral retroperitoneal lymph node sampling (SIRLNS) is required for all patients \\>= 10 years of age with paratesticular tumors who do not have gross nodal involvement on imaging.\n  * Extremity Tumors: Regional lymph node sampling is required for histologic evaluation in patients with extremity tumors.\n  * Clinically or radiographically enlarged nodes must be sampled for histologic evaluation.\n* Patients must have a Lansky (for patients =\\\u003C 16 years of age) or Karnofsky (for patients \\> 16 years of age) performance status score of \\>= 50. 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 performance score.\n* Peripheral absolute neutrophil count (ANC) \\>= 750\u002FuL (within 7 days prior to enrollment).\n* Platelet count \\>= 75,000\u002FuL (transfusion independent) (within 7 days prior to enrollment).\n* Creatinine clearance or radioisotope glomerular filtration rate (GFR) \\>= 70 mL\u002Fmin\u002F1.73 m\\^2 or a serum creatinine (within 7 days prior to enrollment) based on age\u002Fgender as follows:\n\n  * Age: 1 month to \\\u003C 6 months; Maximum serum creatinine (mg\u002FdL): 0.4 (male) : 0.4 (female)\n  * Age: 6 months to \\\u003C 1 year; Maximum serum creatinine (mg\u002FdL): 0.5 (male) : 0.5 (female)\n  * Age: 1 to \\\u003C 2 years; Maximum serum creatinine (mg\u002FdL): 0.6 (male) : 0.6 (female)\n  * Age: 2 to \\\u003C 6 years; Maximum serum creatinine (mg\u002FdL): 0.8 (male) : 0.8 (female)\n  * Age: 6 to \\\u003C 10 years; Maximum serum creatinine (mg\u002FdL): 1 (male) : 1 (female)\n  * Age: 10 to \\\u003C 13 years; Maximum serum creatinine (mg\u002FdL): 1.2 (male) : 1.2 (female)\n  * Age: 13 to \\\u003C 16 years; Maximum serum creatinine (mg\u002FdL): 1.5 (male) : 1.4 (female)\n  * Age \\>= 16 years; Maximum serum creatinine (mg\u002FdL): 1.7 (male) : 1.4 (female)\n* Total bilirubin =\\\u003C 1.5 x upper limit of normal (ULN) for age (within 7 days prior to enrollment), and\n\n  * If there is evidence of biliary obstruction by the tumor, then the total bilirubin must be \\\u003C 3 x ULN for age.\n  * Note: For the purpose of this study, the ULN for SGPT (ALT) has been set to the value of 45 U\u002FL.\n* Serum glutamate pyruvate transaminase (SGPT) (alanine aminotransferase \\[ALT\\]) =\\\u003C 135 U\u002FL\n\n  * If there is evidence of biliary obstruction by the tumor, then the total bilirubin must be \\\u003C 3 x ULN for age\n  * Note: For the purpose of this study, the ULN for SGPT (ALT) has been set to the value of 45 U\u002FL\n* All patients and\u002For their parents or legal guardians must sign a written informed consent.\n* All institutional, Food and Drug Administration (FDA), and National Cancer Institute (NCI) requirements for human studies must be met.\n\nExclusion Criteria:\n\n* Patients who have received prior chemotherapy and\u002For radiation therapy for cancer prior to enrollment. Surgical resection alone of previous cancer(s) is permitted.\n* Patients who have received chemotherapy or radiation for non-malignant conditions (e.g., autoimmune diseases) are eligible. Patients must discontinue chemotherapy for non-malignant conditions prior to starting protocol therapy.\n* Vincristine is sensitive substrate of the CYP450 3A4 isozyme. Patients must not have received drugs that are moderate to strong CYP3A4 inhibitors and inducers within 7 days prior to study enrollment.\n* Patients unable to undergo radiation therapy, if necessary, as specified in the protocol.\n* Evidence of uncontrolled infection.\n* Female patients who are pregnant since fetal toxicities and teratogenic effects have been noted for several of the study drugs. A pregnancy test is required for female patients of childbearing potential.\n* Lactating females who plan to breastfeed their infants.\n* Sexually active patients of reproductive potential who have not agreed to use an effective contraceptive method for the duration of their study participation.","ALL","21 Years",{"count":19,"type":20},205,"ESTIMATED","INTERVENTIONAL",[23],"PHASE3","Rhabdomyosarcoma is a type of cancer that occurs in the soft tissues in the body. This phase III trial aims to maintain excellent outcomes in patients with very low risk rhabdomyosarcoma (VLR-RMS) while decreasing the burden of therapy using treatment with 24 weeks of vincristine and dactinomycin (VA) and examines the use of centralized molecular risk stratification in the treatment of rhabdomyosarcoma. Another aim of the study it to find out how well patients with low risk rhabdomyosarcoma (LR-RMS) respond to standard chemotherapy when patients with VLR-RMS and patients who have rhabdomyosarcoma with DNA mutations get separate treatment. Finally, this study examines the effect of therapy intensification in patients who have RMS cancer with DNA mutations to see if their outcomes can be improved.",[26,27,28],"Embryonal Rhabdomyosarcoma","Fusion-Negative Alveolar Rhabdomyosarcoma","Spindle Cell\u002FSclerosing Rhabdomyosarcoma","RECRUITING","2026-05-01",{"date":32,"type":33},"2026-05-05","ACTUAL",{"date":35,"type":33},"2022-08-04",{"date":37,"type":20},"2030-06-30",{"name":39,"class":40},"Children's Oncology Group","NETWORK",180,{"id":43,"slug":44,"hasResults":11,"nctId":45,"briefTitle":46,"officialTitle":47,"acronym":4,"eligibilityCriteria":48,"healthyVolunteers":49,"sex":16,"minAge":50,"maxAge":51,"enrollmentInfo":52,"targetDuration":54,"studyType":55,"phases":4,"briefSummary":56,"conditions":57,"keywords":76,"overallStatus":29,"whyStopped":4,"lastUpdateSubmitDate":96,"lastUpdatePostDateStruct":97,"startDateStruct":99,"completionDateStruct":101,"leadSponsor":103,"locationsCount":106},"100315102","international-ppbdicer1-registry-100315102","NCT03382158","International PPB\u002FDICER1 Registry","International Pleuropulmonary Blastoma\u002FDICER1 Registry (for PPB, DICER1 and Associated Conditions)","Inclusion Criteria:\n\n1. Known or suspected PPB or related thoracic tumor\n2. Known or suspected sex-cord stromal tumor including Sertoli-Leydig cell tumor and gynandroblastoma (males or females)\n3. Other known or suspected DICER1-related condition including ovarian sarcoma, cystic nephroma, renal sarcoma, pineoblastoma, pituitary blastoma, nasal chondromesenchymal hamartoma, ciliary body medulloepithelioma and others\n4. Individuals with known or suspected DICER1 pathogenic variation regardless of whether they have an established DICER1-associated condition\n5. Informed consent by patient\u002F or parent\u002Fguardian (also, where appropriate: assent and HIPAA consent)\n\nExclusion criteria:\n\nAbsence of appropriate consent for Registry participation",true,"0 Minutes","100 Years",{"count":53,"type":20},3400,"10 Years","OBSERVATIONAL","Pleuropulmonary blastoma (PPB) is a rare malignant neoplasm of the lung presenting in early childhood. Type I PPB is a purely cystic lesion, Type II is a partially cystic, partially solid tumor, Type III is a completely solid tumor. Treatment of children with PPB is at the discretion of the treating institution. This study builds off of the 2009 study and will also seek to enroll individuals with DICER1-associated conditions, some of whom may present only with the DICER1 gene mutation, which will help the Registry understand how these tumors and conditions develop, their clinical course and the most effective treatments.",[58,59,60,61,62,63,64,65,66,67,68,69,26,70,71,72,73,74,75],"Pleuropulmonary Blastoma","Sertoli-Leydig Cell Tumor","DICER1 Syndrome","Cystic Nephroma","Wilms Tumor","Pineoblastoma","Renal Sarcoma","Nodular Hyperplasia of Thyroid","Nasal Chondromesenchymal Hamartoma","Ciliary Body Medulloepithelioma","Neuroblastoma","Pituitary Cancer","Ovarian Sarcoma","Gynandroblastoma","Thyroid Carcinoma","Embryonal Rhabdomyosarcoma of Vagina (Diagnosis)","Embryonal Rhabdomyosarcoma of Uterus (Diagnosis)","Embryonal Rhabdomyosarcoma of Cervix",[77,78,79,80,59,61,81,82,83,62,63,64,84,65,85,72,66,86,67,87,68,69,26,88,70,71,89,90,91,92,93,94,95],"pleuropulmonary blastoma","PPB","DICER1","SLCT","CN","DICER1 mutation","DICER1 syndrome","ASK","Thyroid Nodules","NCMH","CBME","ERMS","Peritoneal PPB","pPPB","multinodular goiter","PPB Type I","PPB Type II","PPB Type III","PPB Type Ir","2025-01-28",{"date":98,"type":33},"2025-01-30",{"date":100,"type":33},"2016-12-06",{"date":102,"type":20},"2035-12-06",{"name":104,"class":105},"Children's Hospitals and Clinics of Minnesota","OTHER",1,{"id":108,"slug":109,"hasResults":11,"nctId":110,"briefTitle":111,"officialTitle":112,"acronym":113,"eligibilityCriteria":114,"healthyVolunteers":11,"sex":16,"minAge":4,"maxAge":115,"enrollmentInfo":116,"targetDuration":4,"studyType":21,"phases":118,"briefSummary":119,"conditions":120,"keywords":4,"overallStatus":29,"whyStopped":4,"lastUpdateSubmitDate":123,"lastUpdatePostDateStruct":124,"startDateStruct":126,"completionDateStruct":128,"leadSponsor":130,"locationsCount":106},"100567501","phase-3-chemo-immunotherapy-in-patients-under-18-years-of-age-with-bone-and-soft-tissue-sarcomas-100567501","NCT06669013","Chemo-immunotherapy in Patients Under 18 Years of Age With Bone and Soft Tissue Sarcomas","A Randomized, Multicenter, Open-label Phase III Study of Dinutuximab Beta With Investigator's Choice of Chemotherapy in Patients Under 18 Years of Age With Bone and Soft Tissue Sarcomas With High Levels of GD2 Expression and Disease Progression During 1st Line Chemotherapy","FollowTheDIN","Inclusion Criteria:\n\n1. Signed written informed consent form;\n2. Age under 18 years of age;\n3. Histologically confirmed GD2-positive osteogenic sarcoma, Ewing's sarcoma, soft tissue and undifferentiated sarcomas;\n4. Prior to study enrollment, patients must have been treated with one or more lines of adequate chemotherapy and must have relapsed on this therapy or have refractoriness to it;\n5. General satisfactory condition of the patient (Lansky scale activity 80-100% (children under 16 years of age), Karnofsky scale 80-100% (children over 16 years of age); ECOG - 0-1);\n6. Sufficient cardiopulmonary reserves of the patient's organism (ECG (ELECTROCARDIOGRAPHY) data within normal limits, ventricular ejection fraction \\> 75% of the upper limit of normal;\n7. Adequate liver function (ALT (ALANINE AMINOTRANSFERASE) ≤ 2.5 \\* VGN, AST (ASPARTATE AMINOTRANSFERASE) ≤ 2.5 \\* VGN), kidney (creatinine \\\u003C1.5 \\* VGN), red bone marrow (granulocytes\\> 2.0 \\* 109\u002FL, platelets\\> 150 \\* 109\u002FL).\n\n   Six months later, two additional criteria were formulated:\n8. Life expectancy at the time of initiation of therapy within the framework of the study is not less than 12 months\n9. Oligometastasis disease (presence of 1 to 5 distant metastatic foci) at restaging at the time of the decision to include the patient in the study;\n\nExclusion Criteria:\n\n1. Withdrawal of consent by the patient or his\u002Fher parent\u002Fguardian.\n2. Exclusion of the patient by the investigator for safety or ethical reasons.","18 Years",{"count":117,"type":20},40,[23],"Data from 40 patients are planned to be included in the study to randomize approximately 10 patients.\n\nThis study involves patients with advanced\u002Fmetastatic GD2-positive rhabdomyosarcoma after progression on 1st line of chemotherapy, advanced\u002Fmetastatic GD2-positive Ewing sarcoma after progression on 1st line of chemotherapy and advanced\u002Fmetastatic GD2-positive osteosarcoma after progression on 1st line of chemotherapy.\n\nAll patients will receive therapy until disease progression (a total of 6 courses of immunotherapy).\n\nThe primary objective of the study is to determine the efficacy and safety of dinutuximab beta with investigator's choice of chemotherapy.",[121,26,122],"Bone Sarcoma","Alveolar Rhabdomyosarcoma","2024-10-31",{"date":125,"type":33},"2024-11-01",{"date":127,"type":33},"2021-05-20",{"date":129,"type":20},"2025-09",{"name":131,"class":105},"N.N. Petrov National Medical Research Center of Oncology"]