[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"melanoma-and-other-malignant-neoplasms-of-skin\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:melanoma-and-other-malignant-neoplasms-of-skin":36},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,2,0,[8,56],{"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":37,"overallStatus":43,"whyStopped":4,"lastUpdateSubmitDate":44,"lastUpdatePostDateStruct":45,"startDateStruct":48,"completionDateStruct":50,"leadSponsor":52,"locationsCount":55},"100292981","phase-1-study-of-aerosol-gemcitabine-in-patients-with-solid-tumors-and-pulmonary-metastases-100292981",false,"NCT03093909","Study of Aerosol Gemcitabine in Patients With Solid Tumors and Pulmonary Metastases","Phase I Study of Aerosol Gemcitabine in Patients With Solid Tumors and Pulmonary Metastases","Inclusion Criteria:\n\n1. Patients with diagnosis of solid tumor with lung metastases and patient's current disease state must be one for which there is no known curative therapy or therapy proven to prolong survival with an acceptable quality of life.\n2. Willing to comply with protocol therapy and required safety monitoring (self-report, pulse oximetry, remote spirometry, labs).\n3. Adequate organ function as defined by: peripheral absolute neutrophil count (ANC) \\>\u002F= 1,000\u002Fmm3, platelet count \\>\u002F= 100,000\u002Fmm3 (transfusion independent defined as not receiving platelet transfusions within a 7 day period prior to enrollment), hemoglobin \\>\u002F= 8.0g\u002Fdl (may receive RBC transfusions), renal-creatinine \\\u003C\u002F= 2 x ULN; hepatic- bilirubin and AST \\\u003C\u002F= 5x ULN; pulmonary: FVC \\>\u002F=50% predicted, Oxyhemoglobin saturation at rest \\>\u002F=95% (off supplemental oxygen).\n4. Patient age \\>\u002F= 12 years and \\\u003C\u002F= 50 years.\n5. Performance Status: ECOG \\\u003C\u002F= 2 for patients \\>\u002F= 16 years old or Lansky play \\>\u002F= 60% for patients \\\u003C\u002F=15 years old.\n6. Patients must have resolution of all acute toxic effects (excluding alopecia) of any prior anti-cancer therapy to NCI CTCAE Grade \\\u003C\u002F= 1 or to the baseline laboratory values as defined in the inclusion criteria.\n7. No radiotherapy within 2 weeks.\n8. Subjects who received GCB systemically previously are eligible for participation.\n\nExclusion Criteria:\n\n1. Currently being treated with bronchodilators or corticosteroids or known to have active asthma. This will not include patients who suffered from asthma as a child and outgrew it.\n2. Pregnant or breastfeeding women will not be entered into this study due to risks of fetal and teratogenic adverse events as seen in animal studies. Pregnancy tests must be obtained in females who are post-menarchal and of child bearing potential (e.g. female that has not been amenorrheic for at least 12 consecutive months or surgically sterilized). Males or females of reproductive potential will not participate unless they have agreed to use effective contraception for the entire period in which they are receiving protocol therapy and for at least one month after treatment ends. Effective contraception is defined as intrauterine device (IUD), hormonal (birth control pill, injections, implants, patch), tubal ligation and partner's vasectomy. Abstinence is an acceptable method of birth control.\n3. Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, bradycardia, related to cardiac disease, bundle branch block, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness\u002Fsocial situations that would limit compliance with study requirements.\n4. Subjects with baseline symptoms of fever and\u002For cough and\u002For shortness of breath and\u002For wheezing and\u002For fatigue grade \\>\u002F= 2 (CTCAE v4.0).\n5. Patients receiving other concurrent cancer therapy including chemotherapy, immunotherapy, or biologic therapy.\n6. Unresolved toxicities from prior anticancer therapy, defined as having not resolved to NCI CTCAE Grade \\\u003C\u002F= 1 with the exception of alopecia and laboratory values listed per the inclusion criteria. Subjects with irreversible toxicity that is not reasonably expected to be exacerbated by the investigational product may be included (eg, hearing loss).","ALL","12 Years","50 Years",{"count":20,"type":21},44,"ESTIMATED","INTERVENTIONAL",[24],"PHASE1","Any time the words \"you,\" \"your,\" \"I,\" or \"me\" appear, it is meant to apply to the potential participant.\n\nThe goal of this clinical research study is to find the highest tolerable dose of gemcitabine that can be given by inhalation (breathing it as a mist) to patients with solid tumors that have spread to the lungs from other parts of the body.\n\nThe safety and side effects of this drug will also be studied.\n\nThis is an investigational study. Gemcitabine is FDA approved and commercially available for the treatment of pancreatic and lung cancer, and other solid tumors. Its administration by inhalation is investigational. The study doctor can explain how the study drug is designed to work.\n\nUp to 44 participants will be enrolled in this study. All will take part at MD Anderson.",[27,28,29,30,31,32,33,34,35,36],"Malignant Neoplasm of Bone and Articular Cartilage","Malignant Neoplasms of Female Genital Organs","Malignant Neoplasms of Independent (Primary) Multiple Sites","Malignant Neoplasms of Lip Oral Cavity and Pharynx","Malignant Neoplasm of Male Genital Organs","Malignant Neoplasms of Mesothelial and Soft Tissue","Malignant Neoplasm of Respiratory and Intrathoracic Organ Carcinoma","Malignant Neoplasms of Thyroid and Other Endocrine Glands","Malignant Neoplasms of Urinary Tract","Melanoma and Other Malignant Neoplasms of Skin",[38,39,40,41,42],"Solid Tumors and Pulmonary Metastases","aerosol gemcitabine","aerosol GCB","Lung metastases","osteosarcoma","RECRUITING","2026-06-16",{"date":46,"type":47},"2026-06-18","ACTUAL",{"date":49,"type":47},"2017-11-22",{"date":51,"type":21},"2027-11-30",{"name":53,"class":54},"M.D. Anderson Cancer Center","OTHER",1,{"id":57,"slug":58,"hasResults":11,"nctId":59,"briefTitle":60,"officialTitle":61,"acronym":62,"eligibilityCriteria":63,"healthyVolunteers":11,"sex":16,"minAge":64,"maxAge":65,"enrollmentInfo":66,"targetDuration":4,"studyType":68,"phases":4,"briefSummary":69,"conditions":70,"keywords":84,"overallStatus":43,"whyStopped":4,"lastUpdateSubmitDate":90,"lastUpdatePostDateStruct":91,"startDateStruct":93,"completionDateStruct":95,"leadSponsor":97,"locationsCount":55},"100598488","an-international-study-on-pediatric-patients-with-rare-tumors-100598488","NCT07072143","An International Study on Pediatric Patients With Rare Tumors.","The PARTNER Study - An International Prospective Observational Study on Pediatric Patients With Very Rare Tumors.","PARTNER","Inclusion Criteria:\n\n* Children and adolescents (age 0-18 years) with a primary or relapsed Very Rare Tumor diagnosed and\u002For treated in a participating country\u002Fcenter.\n* Written informed consent from the patient and\u002For the parent\u002Flegal guardian\n\nExclusion Criteria:\n\n* Absence of Written informed consent from the patient and\u002For the parent\u002Flegal guardian","0 Years","18 Years",{"count":67,"type":21},6250,"OBSERVATIONAL","The PARTNER study is an international, prospective, observational study of paediatric patients with very rare tumours.",[71,36,72,73,74,75,76,77,78,79,80,81,82,83],"Paraganglioma\u002F Phaeochromocytoma","Gastrointestinal Stromal Tumor (GIST)","Adrenocortical Tumor","Pancreatic Tumors","Esthesioneuroblastoma, Olfactory","Mesothelioma","Nasopharyngeal Carcinoma (NPC)","NUT Carcinoma","Pleuropulmonary Blastoma","Salivary Gland Tumors","Thymic Tumors","Thyroid Carcinoma","Appendiceal Cancers",[85,86,87,88,89],"children","rare tumors","very rare tumors","adolescents","PARTNER Study","2025-07-16",{"date":92,"type":47},"2025-07-18",{"date":94,"type":47},"2025-01-25",{"date":96,"type":21},"2049-06-06",{"name":98,"class":54},"Azienda Ospedaliera di Padova"]