[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"progressive-disease\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:progressive-disease":29},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,3,0,[8,43,68],{"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":25,"conditions":26,"keywords":4,"overallStatus":30,"whyStopped":4,"lastUpdateSubmitDate":31,"lastUpdatePostDateStruct":32,"startDateStruct":35,"completionDateStruct":37,"leadSponsor":39,"locationsCount":42},"100435791","phase-2-assessment-of-retreatment-with-lutathera-in-patients-with-new-progression-of-intestinal-well-differenciated-net-100435791",false,"NCT04954820","Assessment of Retreatment With Lutathera® in Patients With New Progression of Intestinal Well-differenciated NET","A Prospective Randomized Phase II Study Assess the Schema of Retreatment With Lutathera® ([177LU]LU-DOTA-TATE) in Patients With New Progression of Intestinal Well-differenciated Neuroendocrine Tumor","ReLUTH","Inclusion Criteria:\n\n* Age ≥ 18 years,\n* Histologically proven intestinal G1 or G2 neuroendocrine tumors (NET),\n* Patient previously treated with 4 cycles of Lutathera® (defined as \"First PRRT\"),\n* Disease control after \"First PRRT\" ≥ 12 months,\n* Patient presenting a progression of disease (clinic, biologic and\u002For radiologic) after a first PRRT,\n* Decision of retreatment with Lutathera® (defined as \"Second PRRT\") validated by RENATEN and\u002For multidisciplinary tumor board and in the scope of the French reimbursement process,\n* ECOG performance status 0-2,\n* Life expectancy ≥ 6 months as prognosticated by the physician,\n* Somatostatin receptor imaging positive imaging (SSTRi+) disease within 4 months prior to inclusion : (may be PET imaging (68Ga-based SSTR analogues) or scintigraphy imaging: 111In-pentetreotide or 99mTc-octreotide. At least 90% of lesions must be positive for SSTRi with a significant uptake (\\>= liver of surrounding tissue),\n* Measurable disease per RECIST 1.1 (Appendix 1), on CT\u002FMRI scans, defined as at least 1 lesion with ≥ 1 cm in longest diameter, and ≥ 2 radiological tumors lesions in total,\n* Adequate bone marrow reserve (Hb \\> 8 g\u002Fdl, neutrophils ≥ 1500\u002Fmm³ and platelets ≥ 80 000\u002Fmm³),\n* Negative pregnancy test in women of childbearing potential (the β-HCG dosage must be ≤ 4 days before inclusion). Women who have no reproductive potential are postmenopausal women or women who have had permanent sterilization, eg. tubal occlusion, hysterectomy, bilateral salpingectomy),\n* Effective contraception in men or women of childbearing or pre-menopausal age and up to a minimum of 6 months following the end of treatment,\n* Patient´s signed written informed consent,\n* Willingness and ability to comply with scheduled visits, treatment plan, laboratory tests and other study procedures,\n* Affiliation to the French Social Security System\n\nExclusion Criteria:\n\n* Patient who did not respond (no CR, PR or SD) to \"first PRRT\".\n* Radiological progression after two cycles of \"Second PRRT\" according to RECIST version 1.1,\n* Grade 4 hematotoxicity and\u002For nephrotoxicity during the initial PRRT, or unresolved AEs categorized as Grade 2 or higher (as per Common Terminology Criteria for Adverse Events (CTCAE v5.0) from previous PRRT cycles or any other therapy for NET, excluding alopecia and peripheral neuropathy,\n* Pancreatic NET,\n* NeuroEndocrine Carcinoma,\n* Prior external beam radiation therapy to more than 25% of the bone marrow,\n* Severe renal (estimated Glomerular Filtration Rate (GFR) according to Modification of Diet in Renal Disease (MDRD) \\\u003C 40 mL\u002Fmin or nephrotic syndrome) or hepatic insufficiency (Alanine aminotransferase (ALT)\u002F aspartate aminotransferase (AST) \\> 2.5 x ULN or ALT\u002FAST \\> 5 x ULN if liver function abnormalities are due to the underlying malignancy and\u002For total serum bilirubin \\> 2.5 x ULN),\n* Serum albumin \\\u003C 3.0 g\u002FdL unless prothrombin time is within the normal range,\n* Uncontrolled diabetes mellitus as defined by a fasting blood glucose above 2 ULN,\n* Uncontrolled decompensated heart failure, myocardial infarction uncontrolled, stroke, pulmonary embolism or revascularization procedure, unstable angina pectoris, uncontrolled cardiac arrhythmia, and clinically significant bradycardia during the last 12 months,\n* Hypertension that cannot be controlled despite medications (≥ 160\u002F95 mmHg despite optimal medical therapy)\n* Brain metastases (unless these metastases have been treated and stabilized for at least 24 weeks, prior to enrolment in the study. Patients with a history of brain metastases must have a head CT scan with contrast or MRI to document stable disease prior to enrolment in the study),\n* Pregnancy or breast feeding,\n* Substance abuse, medical, psychological, or social conditions that may interfere with the patient's participation in the study or evaluation of the study results,\n* Known hypersensitivity to any of the study drugs, study drug classes, or any constituent of the products,\n* Concomitant participation or participation within the last 30 days in another clinical trial,\n* History of other solid tumor in 5 years before the inclusion excepted of cancer in situ of the cervix and skin cancer (basal or squamous cell) treated and controlled.\n* Legal incapacity or physical, psychological or mental status interfering with the patient's ability to sign the informed consent or to terminate the study.","ALL","18 Years",{"count":20,"type":21},146,"ESTIMATED","INTERVENTIONAL",[24],"PHASE2","In France, since the reimbursement of Lutathera®, this treatment is allowed for retreatment if patients still fulfill the criteria of its indication and 4 news cycles could be proposed. However, clinical practices are heterogeneous regarding the number of new cycles and most teams perform only two additional cycles (every 8 weeks). Therefore, the coordinator propose to evaluate the efficacy of two additional cycle of Lutathera® versus active surveillance in patients already retreated with two cycles Lutathera® for a new progression of intestinal neuroendocrine tumor and who previously received the 4 cycles of treatment with a clinical benefit.",[27,28,29],"Neuroendocrine Tumors","Intestinal Well Differentiated Endocrine Tumor","Progressive Disease","RECRUITING","2026-06-02",{"date":33,"type":34},"2026-06-04","ACTUAL",{"date":36,"type":34},"2021-10-18",{"date":38,"type":21},"2033-10",{"name":40,"class":41},"Institut du Cancer de Montpellier - Val d'Aurelle","OTHER",28,{"id":44,"slug":45,"hasResults":11,"nctId":46,"briefTitle":47,"officialTitle":47,"acronym":4,"eligibilityCriteria":48,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":49,"enrollmentInfo":50,"targetDuration":4,"studyType":22,"phases":52,"briefSummary":54,"conditions":55,"keywords":4,"overallStatus":30,"whyStopped":4,"lastUpdateSubmitDate":58,"lastUpdatePostDateStruct":59,"startDateStruct":61,"completionDateStruct":63,"leadSponsor":65,"locationsCount":67},"100636067","phase-1-first-in-cancer-type-phase-i-study-of-ft536-for-recurrent-who-grade-4-astrocytoma-100636067","NCT07560865","First-in Cancer-Type Phase I Study of FT536 for Recurrent WHO Grade 4 Astrocytoma","Inclusion Criteria:\n\n* Histologically confirmed WHO Grade 4 astrocytoma from archival tissue. IDH mutation status and MGMT promoter methylation status will not limit candidacy but needs to be known.\n* Evidence of first or second cancer recurrence\u002F progression by magnetic resonance imaging (MRI) for which a gross tumor resection (GTR) is feasible as determined by the primary investigator in concordance with the study-affiliated neurosurgeon.\n* Previous completed SOC antitumor treatment including surgery, radiation therapy, and temozolomide +\u002F- Optune\u002F Tumor Treatment Fields (TTF).\n* No concurrent alternative curative therapy, including use of TTF.\n* Able to undergo standard MRI scans with contrast agent throughout the course of the study.\n* ≥ 18 years and ≤ 75 years of age at the time of consent.\n* Karnofsky performance status ≥70.\n* Must be completely off or on a dose of dexamethasone 2mg daily or less with stable neurological function at the time of enrollment.\n* Adequate organ function within 14 days of study treatment start as defined in Section 4.1.9 of the protocol.\n* Participants of childbearing potential (POCBP) or with partners of childbearing potential must use a highly effective form of contraception from the time of the screening visit until at least 3 months after the dose of FT536.\n* Must agree to and sign the consent for the companion Long-Term Follow-Up study (CPRC# 2021LS077).\n* Voluntary written consent prior to the performance of any research related procedures.\n* Agree to stay in the Twin Cities metropolitan area (i.e. within a 45-minute drive of the UMN) from the time of biopsy through hospital discharge following completion of the planned craniotomy.\n\nExclusion Criteria:\n\n* Clinically significant increased intracranial pressure (e.g., impending herniation or requirement for immediate palliative treatment) or uncontrolled seizures or any other situation requiring urgent neurosurgical intervention.\n* History of myelodysplastic syndrome (MDS)\u002F acute myeloid leukemia (AML) or with features suggestive of MDS\u002F AML.\n* Radiographic evidence of leptomeningeal disease.\n* Received prior treatment with bevacizumab or any other cellular therapy available on or off a clinical trial.\n* Non-malignant CNS disease such as CNS vasculitis or neurodegenerative disease.\n* Prior or current GammaTile, Gliadel wafer use, or other implanted therapeutic agent or photodynamic therapy.\n* Any known condition that requires systemic immunosuppressive therapy - inhaled and topical steroids are permitted.\n* Pregnant or breastfeeding. Menstruating POCBP must have a negative pregnancy test within 14 days before the planned biopsy. Patient must agree to use highly effective method of birth control from the time of the screening visit until at least 3 months after the dose of FT536.\n* Known seropositive for HIV or known Hepatitis B or C infection with detectable viral load by PCR.\n* Prior history of malignancy within 5 years of enrollment other than basal or squamous cell carcinoma of the skin, cervical intra-epithelial neoplasia, in situ carcinoma of the breast, or prostate cancer treated with surgery or RT with a prostate specific antigen of \\\u003C0.01 ng\u002FmL tested within 28 days of trial enrollment.\n* Uncontrolled intercurrent illness including, but not limited to ongoing or active infection, symptomatic congestive heart failure, unstable angina pec","75 Years",{"count":51,"type":21},9,[53],"PHASE1","This is a single center, first-in cancer-type phase I clinical trial of FT536 for adult patients with recurrent WHO Grade 4 astrocytoma, irrespective of IDH-mutational status, for which a standard of care repeat craniotomy for gross tumor resection at time of first or second recurrence is achievable. Per this treatment schema, FT536 will be administered once intratumorally",[56,57,29],"Astrocytoma","Glioblastoma","2026-04-24",{"date":60,"type":34},"2026-05-01",{"date":62,"type":34},"2026-04-23",{"date":64,"type":21},"2029-06-01",{"name":66,"class":41},"Masonic Cancer Center, University of Minnesota",1,{"id":69,"slug":70,"hasResults":11,"nctId":71,"briefTitle":72,"officialTitle":73,"acronym":4,"eligibilityCriteria":74,"healthyVolunteers":11,"sex":17,"minAge":75,"maxAge":76,"enrollmentInfo":77,"targetDuration":4,"studyType":22,"phases":79,"briefSummary":81,"conditions":82,"keywords":85,"overallStatus":30,"whyStopped":4,"lastUpdateSubmitDate":96,"lastUpdatePostDateStruct":97,"startDateStruct":99,"completionDateStruct":101,"leadSponsor":103,"locationsCount":67},"100585316","oral-tacrolimus-vs-dexamethasone-micro-pulse-therapy-in-pediatric-rapidly-progressing-vitiligo-a-multicenter-rct-100585316","NCT06900777","Oral Tacrolimus vs Dexamethasone Micro-pulse Therapy in Pediatric Rapidly Progressing Vitiligo: A Multicenter RCT","Oral Tacrolimus Capsule Versus Dexamethasone Micro-pulse Therapy for the Treatment of Rapidly Progressing Vitiligo in Children: A Multicenter, Randomized, Controlled Study","Inclusion Criteria:\n\n* Children aged 4-12 years diagnosed with rapidly progressive non-segmental vitiligo (VIDA score ≥4, indicating disease progression within the past 6 weeks).\n\nTotal body surface area (BSA) affected by vitiligo between 1% and 50%. Guardians provide written informed consent for the child's participation.\n\nExclusion Criteria:\n\n* Stable-phase childhood vitiligo. Segmental, mucosal, undetermined, or generalized vitiligo. Systemic immunosuppressive therapy within the past 4 weeks. Known hypersensitivity to tacrolimus, other macrolide drugs, or study drug excipients.\n\nComorbidities precluding oral tacrolimus use (e.g., severe hepatic\u002Frenal dysfunction).\n\nObesity or systemic diseases (e.g., tuberculosis, acute\u002Fchronic infections, hypertension, congenital cardiovascular disease).\n\nAny condition deemed by investigators to increase participant risk or interfere with trial execution.","4 Years","12 Years",{"count":78,"type":21},90,[80],"NA","This clinical study aims to compare the safety and effectiveness of two treatments-oral Tacrolimus capsules and Dexamethasone micro-pulse therapy-in children aged 4-12 years with rapidly progressing vitiligo. The study is a multicenter, randomized, controlled trial involving 90 participants, who will be divided equally into two groups. One group will receive daily Tacrolimus, while the other will take Dexamethasone on weekends. Over 24 weeks, doctors will monitor improvements in skin repigmentation, side effects, and overall health through regular check-ups and blood tests. The goal is to determine which treatment better controls disease progression and improves quality of life for children with vitiligo.\n\nKey Points:\n\n* For children with rapidly spreading vitiligo.\n* Compares two common medications.\n* Follows participants for 6 months.\n* Focuses on safety and effectiveness.",[83,84,29],"Vitiligo","Child",[86,87,88,89,83,90,91,92,93,94,95],"Tacrolimus","Dexamethasone","Randomized Controlled Trialy","Children","Safety","Efficacy","Multicenter Study","VASI Score","IGA Score","Immunosuppressive Therapy","2025-06-16",{"date":98,"type":34},"2025-06-19",{"date":100,"type":34},"2025-04-01",{"date":102,"type":21},"2026-04-01",{"name":104,"class":41},"Xijing Hospital"]