[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"leptomeningeal-disease\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:leptomeningeal-disease":27},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,7,0,[8,41,63,88,131,162,183],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":4,"eligibilityCriteria":15,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":18,"targetDuration":4,"studyType":21,"phases":22,"briefSummary":24,"conditions":25,"keywords":4,"overallStatus":28,"whyStopped":4,"lastUpdateSubmitDate":29,"lastUpdatePostDateStruct":30,"startDateStruct":33,"completionDateStruct":35,"leadSponsor":37,"locationsCount":40},"100241546","phase-2-prospective-evaluation-of-high-dose-systemic-methotrexate-in-patients-with-breast-cancer-and-leptomeningeal-metastasis-100241546",false,"NCT02422641","Prospective Evaluation Of High-Dose Systemic Methotrexate In Patients With Breast Cancer And Leptomeningeal Metastasis","Traditional Incision and Drainage of Cutaneous Abscess Vs. Minimally Invasive Incision and Drainage With Vessel Loop: A Randomized Controlled Trail","Inclusion Criteria\n\n* Adults (male and female) age \\>18\n* Eastern Cooperative Group (ECOG) Performance Scale 0-1 (see Appendix I)\n* Histologically or cytologically confirmed invasive breast cancer of the following subtype:\n* TRIPLE NEGATIVE (ER-negative, PR-negative, and HER2-negative disease). Triple-negative patients will be defined per ASCO-CAP Guidelines.\n* HER2-POSITIVE: HER2-positive patients will be defined per ASCO-CAP Guidelines.\n* HORMONE REFRACTORY: Patients with ER\u002FPR-positive disease according to ASCO-CAP guidelines above may be considered if they have disease progression after two lines of hormonal therapy (administered in the adjuvant or metastatic setting), or are deemed clinically hormone-resistant taking into consideration the rate of progression of disease or a short interval of time on first line hormonal therapy before progression. Clinically hormone-resistant patients MUST also be discussed with the Study Chair, Study co-chair or designee in advance for approval.\n\nNOTE: ASCO-CAP guidelines state that ER and PR assays be considered positive if there are at least 1% positive tumor nuclei in the sample on testing in the presence of expected reactivity of internal (normal epithelial elements) and external controls. HER2-positive is defined as HER2 IHC 3+, ISH ≥ 2.0, or average HER2 copy number ≥ 6.0 signals.\n\nNOTE: A patient who has a change in receptor status (e.g. PR negative to positive) may be stratified as triple negative or hormone positive, contrary to the most recent receptor testing, for the purposes of the study, based upon the clinical course at the discretion of the Study Chair, Study co-chair, or designee in advance for approval.\n\n* Cytologic or unequivocal radiographic confirmation of leptomeningeal metastasis by dural puncture and\u002For neuroimaging with or without known brain metastasis\n* Adequate organ function as follows:\n\nEstimated creatinine clearance \\>70 cc\u002Fmin (calculated by Cockcroft-Gault formula) White blood cell counts \\>3000 cells\u002FmcL Absolute neutrophil count \\>1500 cells\u002FmcL Platelet count \\>100,000 cells\u002FmcL Hematocrit \\>30% Serum bilirubin \\\u003C1.5 x the ULN or \\\u003C5x the ULN if secondary to liver metastasis Alanine aminotransferase or aspartate aminotransferase \\\u003C2.5x the ULN or \\\u003C5x the ULN if secondary to liver metastasis Alkaline phosphatase \\\u003C2.5x the ULN or \\\u003C5x the ULN if secondary to liver metastasis\n\n\\- Able to provide confirmed consent\n\nExclusion Criteria\n\n* Prior allergy or adverse reaction to methotrexate\n* New York Heart Association Heart Failure Class \\>3\n* Active diabetes insipidus\n* Active mucositis\n* Chemotherapy or stereotactic radiotherapy within the last 2 weeks\n* Partial brain radiotherapy (i.e. \\\u003C40% of total brain volume) within the last 2 weeks\n* Whole brain radiotherapy within the last 6 months or partial brain radiotherapy exceeding \\>40% of total brain volume within the last 6 months\n* Prior treatment with any methotrexate containing systemic regimen within 1 year (excluding intrathecal methotrexate)\n* Concurrent or planned systemic chemotherapy, radiotherapy, new hormonal or anti- HER2 directed therapy directed at management of breast cancer (existing anti-HER2 therapy can be continued as recently recommended in the National Consensus Guidelines (26)\n* Uncontrolled or progressive systemic disease or other concurrent condition which in the Investigator's opinion makes HD-MTX an undesirable treatment option for the patient or would jeopardize compliance\n* Contraindication to MRI\n* Use of salicylates, non-steroidal anti-inflammatory drugs, or sulfonamide medications within one week of start of methotrexate\n* Pregnant women or women who are breastfeeding.\n* Patients with significant visceral fluid collections including ascites, pericardial effusions, pleural effusions or others may experience delayed clearance of methotrexate because of third space accumulation which could result in methotrexate toxicity and inability to tolerate the proposed study treatment. While these are not absolute exclusions the Study Chair or co-Chairs should be contacted to discuss possible enrollment. Patients with significant ascites defined as European Association for the Study of the Liver \\> grade 2 (Appendix IV), or with asymptomatic pleural effusions with an estimated size \\>200 mL, or with symptomatic pleural effusion of any size will be excluded.\n\nNOTE: Systemic staging of the chest\u002Fabdomen\u002Fpelvis is required for study entry. See Sections 8.1.9. Body fluid will be assessed based on this study.","ALL","18 Years",{"count":19,"type":20},16,"ESTIMATED","INTERVENTIONAL",[23],"PHASE2","This study is a prospective evaluation of systemic, intravenous high-dose methotrexate (HD-MTX, 8 g\u002Fm2) in patients with triple negative, HER2-positive, and hormone refractory breast cancer with leptomeningeal metastasis (LMD) with or without brain parenchymal involvement.",[26,27],"Metastatic Breast Cancer","Leptomeningeal Disease","RECRUITING","2026-06-30",{"date":31,"type":32},"2026-07-02","ACTUAL",{"date":34,"type":4},"2015-05",{"date":36,"type":20},"2027-07",{"name":38,"class":39},"Wake Forest University Health Sciences","OTHER",3,{"id":42,"slug":43,"hasResults":11,"nctId":44,"briefTitle":45,"officialTitle":45,"acronym":4,"eligibilityCriteria":46,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":47,"targetDuration":4,"studyType":21,"phases":49,"briefSummary":51,"conditions":52,"keywords":4,"overallStatus":28,"whyStopped":4,"lastUpdateSubmitDate":53,"lastUpdatePostDateStruct":54,"startDateStruct":56,"completionDateStruct":58,"leadSponsor":60,"locationsCount":62},"100624852","optimizing-contrast-dose-and-scanning-parameters-for-detection-of-leptomeningeal-disease-100624852","NCT07415018","Optimizing Contrast Dose and Scanning Parameters for Detection of Leptomeningeal Disease","Inclusion Criteria:\n\n* Patients with tissue confirmed solid malignancy and standard of care brain MRI with equivocal results for LMD (questionable or possible) and negative LP CSF sampling or patients with high risk clinical LMD and negative brain MR and LP CSF sampling. Initially, we will target solid tumors, but if more patients are needed to meet the study power we will enroll liquid tumors.\n* Participants \\> 18 years of age.\n* Participants are able to consent.\n\nExclusion Criteria:\n\n* Participants with CSF sampling positive for LMD or MR brain\u002Fspine with definitive evidence of LMD.\n* Participants with implantable devices that can not be scanned with MR safe mode for participant safety.\n* Pregnant participants or potentially pregnant participants are at risk of contrast on the fetus\n\nPediatric participants \\\u003C 18 years of age.",{"count":48,"type":20},40,[50],"NA","To learn if gadopiclenol (a contrast agent) used during MRI scanning can help in the detection of early LMD.",[27],"2026-06-17",{"date":55,"type":32},"2026-06-18",{"date":57,"type":32},"2026-06-10",{"date":59,"type":20},"2029-07-31",{"name":61,"class":39},"M.D. Anderson Cancer Center",1,{"id":64,"slug":65,"hasResults":11,"nctId":66,"briefTitle":67,"officialTitle":68,"acronym":4,"eligibilityCriteria":69,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":70,"targetDuration":72,"studyType":73,"phases":4,"briefSummary":74,"conditions":75,"keywords":77,"overallStatus":28,"whyStopped":4,"lastUpdateSubmitDate":79,"lastUpdatePostDateStruct":80,"startDateStruct":82,"completionDateStruct":84,"leadSponsor":86,"locationsCount":5},"100527303","non-interventional-german-leptomeningeal-disease-register-100527303","NCT06146010","Non Interventional German Leptomeningeal Disease Register","Deutsches Meningeosis Neoplastica Register","Inclusion Criteria:\n\n* Patients with leptomeningeal disease\n* Written consent of the patient or legal guardian.\n* Capacity to give consent or legal guardianship\n* Age ≥ 18 years\n\nExclusion Criteria:\n\n* Lack of informed consent from the patient\n* Lack of capacity to consent on the part of the person concerned or lack of legal guardianship\n* Age \\\u003C 18 years",{"count":71,"type":20},50,"5 Years","OBSERVATIONAL","The planned multicenter register is intended to create a database in the form of a cancer register on the incidence and course of disease in Germany of leptomeningeal disease, the therapeutic measures administered in the real world and the complications.",[76,27],"Meningeal Neoplasms",[78],"Meningeosis Neoplastica","2026-04-02",{"date":81,"type":32},"2026-04-08",{"date":83,"type":32},"2024-06-26",{"date":85,"type":20},"2029-12",{"name":87,"class":39},"University Hospital Tuebingen",{"id":89,"slug":90,"hasResults":11,"nctId":91,"briefTitle":92,"officialTitle":93,"acronym":4,"eligibilityCriteria":94,"healthyVolunteers":11,"sex":16,"minAge":95,"maxAge":96,"enrollmentInfo":97,"targetDuration":4,"studyType":21,"phases":99,"briefSummary":101,"conditions":102,"keywords":116,"overallStatus":120,"whyStopped":4,"lastUpdateSubmitDate":121,"lastUpdatePostDateStruct":122,"startDateStruct":124,"completionDateStruct":126,"leadSponsor":128,"locationsCount":130},"100622970","phase-1-b7-h3cd28zcart-in-cns-neoplasms-100622970","NCT07390539","B7-H3.CD28Z.CART in CNS Neoplasms","A Phase 1\u002F1b Study of Autologous b7-h3 Chimeric Antigen Receptor t Cells (b7-h3.cd28z.Cart) in Children and Young Adults With Recurrent or Progressive Cns Neoplasms Expressing b7-h3 Target","Pre-screening Inclusion Criteria:\n\n* Participants must have histologically and\u002For molecularly confirmed CNS embryonal tumor (see eligible tumor types below), OR ependymoma that is recurrent\u002Fprogressive following standard of care treatment.\n\n  --Eligible CNS embryonal tumor types include:\n  * Medulloblastoma\n  * Atypical Teratoid Rhabdoid Tumor (ATRT)\n  * Embryonal Tumor with Multilayered Rosettes (ETMR) Pineoblastoma\n  * Other CNS embryonal tumor types, at the discretion of the study chair (or designee)\n* Participants must have adequate pre-trial tumor material available to determine B7- H3 expression status. Tumor tissue from the most recent resection or biopsy of recurrent disease is preferred. If unavailable, tumor tissue from prior recurrences or from time of initial diagnosis is acceptable. Biopsies will not be performed for participation in this research trial or for research purposes.\n* Pre-screening IHC Consent: All participants ≥ 18 years of age must be able to give informed consent. For participants \\\u003C18 years of age, their legal authorized representative (LAR) (i.e. parent or guardian) must give informed consent. Pediatric participants will be included in age-appropriate discussion and written assent will be obtained for those ≥10 years of age, where appropriate. If a minor becomes of age during participation of this study, they will be asked to reconsent as an adult.\n\nInclusion Criteria:\n\n* Participants must have histologically and\u002For molecularly confirmed CNS embryonal tumor (see eligible tumor types below), OR ependymoma that is recurrent\u002Fprogressive following standard of care treatment.\n\n  --Eligible CNS embryonal tumor types include:\n  * Medulloblastoma\n  * Atypical Teratoid Rhabdoid Tumor (ATRT)\n  * Embryonal Tumor with Multilayered Rosettes (ETMR)\n  * Pineoblastoma\n  * Other CNS embryonal tumor types, at the discretion of the study chair (or designee)\n* B7-H3 expression: Demonstration of B7-H3 expression with H score greater than 100 by immunohistochemistry (IHC) is required.\n* Age: greater than or equal to two (2) years of age and less than or equal to 21 years of age. The first participant treated at each dose level within each stratum (Standard Risk and High Risk) will be ≥ 6 years of age when feasible.\n* Disease status: Participants must have evaluable disease in the central nervous system to be eligible. Evaluable disease includes either measurable OR non-measurable disease, defined as follows:\n\n  --Measurable disease (contrast-enhancing or non-enhancing tumor)\n  * Clearly defined lesional margins with two perpendicular diameters of at least 10mm, OR\n  * At least two times (in both perpendicular diameters) the MRI slice thickness, plus the interslice gap\n\n    --Non-measurable disease (tumor that is too small to be accurately measured)\n  * Lesion that is measurable in only one perpendicular dimension, OR\n  * Lesion that is less than 10mm in at least one perpendicular dimension, OR\n  * Lesion that is less than two times the MRI slice thickness, plus the interslice gap\n  * Note: Leptomeningeal (LM) disease is considered non-measurable but evaluable.\n* Performance status: Karnofsky performance status ≥60% for participants ≥16 years of age and Lansky performance status ≥60% for participants \\\u003C16 years of age (see APPENDIX A PERFORMANCE STATUS CRITERIA). NOTE: Participants with neurologic deficits must have a stable neurologic exam for seven (7) days prior to enrollment. Participants who are unable to walk because of paralysis, but who are up in a wheelchair, will be considered ambulatory for the purpose of assessing the performance score.\n* Life expectancy of greater than 12 weeks\n* Prior therapy: Participants must have received prior standard of care therapy, including maximal safe surgical resection, radiation therapy and\u002For standard chemotherapy, and is recovered from all acute treatment-related toxicities (defined as ≤ Grade 1 or stable) from all prior therapy before entering this study There is no upper limit to the number of prior therapies allowed, but must have received all standard curative options for their tumor type.\n* Participants must meet the following washouts prior to enrollment:\n\n  * Radiation therapy - Participants must have had their last fraction of:\n\n    ---Craniospinal irradiation, whole brain radiation therapy, or radiation therapy to \\>50% of the pelvis or spine \\>28 days prior to enrollment\n\n    ---Focal irradiation (small port) \\>14 days prior to enrollment\n  * At least 14 days since any prior cytotoxic chemotherapy\n  * At least 7 days since any biologic antineoplastics, tyrosine kinase inhibitor, targeted agent\n  * At least 21 days or 5 half-lives (whichever is shorter) since any investigational antineoplastic or disease-directed agent (but at least 28 days from prior investigational antineoplastic vaccine therapy)\n  * At least 21 days since any monoclonal antibody therapy\n  * At least 90 days since any systemic inhibitor\u002Fstimulatory immune checkpoint therapy\n  * At least 28 days from prior autologous stem cell transplantation, with no ongoing toxicities\n  * At least 14 days after peg-filgrastim and 7 days for hematopoietic growth factor support\n* Steroid use: Must not require concurrent systemic steroid therapy, although physiologic corticosteroid replacement therapy for management of pituitary\u002Fadrenal insufficiency and\u002For topical administration (e.g. inhaled or dermatologic) is allowed. Use of topical, ocular, intranasal, or inhaled corticosteroids are permitted per PI\n\ndiscretion.\n\n* Participants must have adequate organ function, as defined below\n\n  --Adequate bone marrow function\n  * Hemoglobin ≥ 8 g\u002FdL\n  * Absolute neutrophil count (ANC) ≥ 1000 cells\u002FuL\n  * Absolute lymphocyte count (ALC) ≥ 150 cells\u002FuL\n  * Platelets ≥100,000\u002FuL (unsupported, defined as no platelet transfusion within 4 days)\n* Adequate renal function defined as creatinine within normal limits for age OR creatinine clearance (as estimated by Cockcroft Gault Equation for participants ≥ 18yo and Bedside Schwartz for participants \\\u003C18yo) ≥70mL\u002Fmin\n\n  * Maximum Serum Creatinine mg\u002FDL ---6 months to 1 year Male 0.5 Female 0.5 ---1 to \\\u003C 2 years Male 0.6 Female 0.6 ---2 to \\\u003C 6 years Male 0.8 Female 0.8\n\n    * 6 to \\\u003C 10 years Male 1 Female 1\n    * 10 to \\\u003C 13 years Male 1.2 Female 1.2\n    * 13 years to \\\u003C 16 years Male 1.5 Female 1.4\n\n      * 16 years Male 1.7 Female 1.4\n* Adequate hepatic function\n\n  * Serum ALT\u002FAST ≤3.0 upper limit of normal (ULN)\n  * Total bilirubin ≤1.5mg\u002FdL, except in subjects with confirmed Gilbert's syndrome\n* Adequate cardiac function\n\n  --Ejection fraction ≥50% or fractional shortening ≥28%, measured by echocardiography\n* Adequate pulmonary function\n\n  * No evidence of dyspnea at rest\n  * Pulse oximetry \\>92% whilst breathing room air\n* Adequate neurologic function\n\n  * Participants with seizure disorders on anticonvulsants may be enrolled if seizures are well controlled (no seizure activity within 7 days prior to enrollment)\n  * Nervous system disorders (CTCAE v6.0) resulting from prior therapy must be ≤ Grade 2, with the exception of decreased tendon reflex (DTR; any Grade eligible). Participants with neurological deficits should be stable for a minimum of 7 days prior to enrollment. (A baseline detailed neurological exam should clearly document the neurological status of the participant prior at enrollment).\n* Females of childbearing potential must have a negative serum or urine pregnancy test (females who have undergone surgical sterilization are not considered to be of childbearing potential)\n* Participants of childbearing or child-fathering potential must be willing to practice birth control from the time of enrollment on this study and for one year after receiving the preparative lymphodepletion regimen, or for as long as B7- H3.CD28Z.CART cells are detectable in peripheral blood or CSF, whichever is later.\n* Participant or parent of participant or legally recognized representative must be able to sign a written informed consent document. Pediatric participants will be included in age-appropriate discussion and written assent will be obtained for those ≥10 years of age, where appropriate.\n\nExclusion Criteria:\n\n* Participants with bulky tumor are ineligible. Bulky tumor is defined as:\n\n  * Tumor with diameter of \\>5cm in one dimension on T2\u002FFLAIR sequence\n  * Tumor with evidence of clinically significant midline shift or uncal herniation\n  * Tumor that, in opinion of the site investigator, shows significant mass effect in either the brain or spine\n* Participants with clinical or radiological evidence of brain herniation.\n* Participants who have received other B7-H3 targeted cellular therapies. Other prior cellular therapies are eligible, including immune checkpoint inhibition and vaccine therapy. These prior therapies should be discussed with the study chair (or designee) prior to participant enrollment.\n* Concurrent illness\n\n  * Participants with any prior immunodeficiency or history of autoimmune disease requiring systemic steroids\u002F immunosuppressive medication\u002F disease-modifying agents within the last two (2) years.\n  * Uncontrolled (Grade 3) bacterial, viral, fungal, or other infection.\n  * Ongoing infection with HIV or hepatitis B (HBsAg positive) or hepatitis C virus (anti-HCV positive). A history of hepatitis B or hepatitis C is permitted if the viral load is undetectable per quantitative PCR and\u002For nucleic acid testing.\n  * Evidence of severe or uncontrolled systemic disease (e.g. Grade 3 significant cardiac, pulmonary, hepatic, renal or other organ dysfunction) that in the judgement of the principal investigator is likely to interfere with assessment of safety or efficacy of the investigational regimen and its requirements.\n  * Known sensitivity or allergy to any of the agents\u002Freagents used in this study (i.e. DSMO, cyclophosphamide, fludarabine)\n  * History of severe hypersensitivity reaction to compounds of similar chemical or biologic compositions to any agent used in the study or in the manufacturing of cells.\n* Concomitant medications\n\n  * Current systemic corticosteroid therapy\n  * Note, physiologic corticosteroid replacement therapy for adrenal or pituitary insufficiency will be allowed.\n  * Participants who are receiving any other anti-cancer or investigational drug therapy are ineligible.\n  * Participants who have received the last vaccination of a live vaccine ≤ 30 days prior to the start of treatment are ineligible.\n  * Ongoing use of dietary supplements, alternative therapies or extreme diets, or any medication not approved by the study chair (or designee).\n* Any other condition which in the principal investigator's opinion makes the individual clinically unsuitable to participate in this trial, or which would jeopardize compliance with the protocol, or would make it difficult to interpret adverse events or study data.","2 Years","21 Years",{"count":98,"type":20},70,[100],"PHASE1","The purpose of this research study is to test the safety and effectiveness of a cell therapy at different doses for children and young adults with recurrent or progressive brain tumors. Recurrent\u002Frecurred means a tumor that has gone away and then came back. This cell therapy is called B7- H3.CD28Z.CART, referred to as B7-H3 CAR T cells. B7-H3 is a protein that is over-expressed on many tumor cells, making it a good target for cancer cell therapy.\n\nThe names of the study investigational therapies involved in this study are:\n\n* Fludarabine (a type of chemotherapy)\n* Cyclophosphamide (a type of chemotherapy)\n* B7-H3 CAR T cells (a type of cellular therapy)",[103,104,105,106,107,108,109,110,111,112,113,114,115,27],"Central Nervous System Neoplasms","Brain Tumor","Brain Tumor, Recurrent","Brain Tumor, Pediatric","Brain Tumor Adult","Medulloblastoma","Medulloblastoma, Childhood","Medulloblastoma, Adult","Medulloblastoma Recurrent","Ependymoma","Atypical Teratoid\u002FRhabdoid Tumor","Embryonal Tumor With Multilayered Rosettes","Pineoblastoma",[103,104,106,117,118,108,109,110,111,112,113,119,115,27],"Brain Tumor, Adult","Brain Tumor Recurrent","Embryonal Tumor with Multilayered Rosettes","NOT_YET_RECRUITING","2026-01-28",{"date":123,"type":32},"2026-02-05",{"date":125,"type":20},"2026-07",{"date":127,"type":20},"2032-08-31",{"name":129,"class":39},"Robbie Majzner",2,{"id":132,"slug":133,"hasResults":11,"nctId":134,"briefTitle":135,"officialTitle":136,"acronym":137,"eligibilityCriteria":138,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":139,"targetDuration":4,"studyType":21,"phases":141,"briefSummary":142,"conditions":143,"keywords":146,"overallStatus":28,"whyStopped":4,"lastUpdateSubmitDate":152,"lastUpdatePostDateStruct":153,"startDateStruct":155,"completionDateStruct":157,"leadSponsor":159,"locationsCount":161},"100500747","phase-2-capecitabine-tucatinib-and-intrathecal-trastuzumab-for-breast-cancer-patients-with-leptomeningeal-disease-100500747","NCT05800275","Capecitabine, Tucatinib, and Intrathecal Trastuzumab for Breast Cancer Patients With Leptomeningeal Disease","Multicentric Single Arm Phase II Study Evaluating the Efficacy of Association of Tucatinib, Capecitabine and Intra-CSF Trastuzumab in HER2 Amplified Breast Cancer Patients With Leptomeningeal Metastases","ETIC-LM","Inclusion Criteria:\n\n1. Patient must have signed a written informed consent form prior to any trial specific procedures. When the patient is physically unable to give their written consent, a trusted person of their choice, independent from the investigator or the sponsor, can confirm in writing the patient's consent;\n2. Patients ≥18 years old;\n3. Histologically confirmed metastatic breast cancer;\n4. Histologically confirmed HER2 positive breast cancer, with HER2 positive defined by in situ hybridization (ISH), immunohistochemistry (IHC), or fluorescence in situ hybridization (FISH) methodology; Note: HER2 testing should be performed preferably metastatic site; any estrogen and progesterone (ER\u002FPR) status is allowed;\n5. Proven leptomeningeal progression defined by linear leptomeningeal metastases on magnetic resonance imaging (MRI) or the presence of breast cancer cells in CSF (obtained within 28 days before inclusion );\n6. Eastern Cooperative Oncology Group Performance Status (ECOG PS) 0-2;\n7. Life expectancy ≥2 months;\n8. Stable dose of steroids for at least 5 days prior to registration;\n9. If symptomatic brain or leptomeningeal metastasis, local treatment (surgery, radiation therapy) is allowed until 2 weeks before inclusion but should have been completed no more than 8 weeks before inclusion and with no clinical indication for immediate re-treatment with local therapy in the opinion of the investigator;\n10. Adequate hematological function within 14 days before inclusion: Absolute neutrophil count (ANC) ≥1.5 x 10⁹\u002FL; platelets count ≥100 x 10⁹\u002FL; and hemoglobin ≥9.0 g\u002FdL;\n11. Adequate liver function within 14 days before inclusion: total bilirubin ≤1.5 ULN (unless documented Gilbert's syndrome); AST and ALT ≤2.5 ULN (≤5 ULN in the presence of liver metastases);\n12. Normal renal function within 14 days before inclusion: estimated creatinine clearance ≥60 mL\u002Fmin according to the Cockcroft-Gault formula;\n13. Adequate cardiac function:\n\n    * 12 Lead electrocardiograms (ECG) with normal tracing or non-clinically significant changes that do not require medical intervention\n    * QT\u002FQTc interval ≤470 msec for woman and ≤450 msec for men (mean of replicate values, correction per institutional standard) on the ECG at the screening visit and a normal kaliemia\n    * Left ventricular ejection fraction (LVEF) ≥55%\n    * No history of Torsades de Pointes or other symptomatic QTc abnormality\n14. Resolution of all acute toxic effects of prior anti-cancer therapy or surgical procedures to National cancer institute-Common terminology criteria for adverse events (NCI-CTCAE) version 5.0 grade 1 or 0 to baseline (except alopecia or other toxicities not considered a safety risk for the patient at investigator's discretion);\n15. Women of childbearing potential must have a negative pregnancy test (blood or urine test) within 14 days prior to inclusion;\n16. Woman of childbearing potential and male patients must agree to use adequate contraception for the duration of trial participation and up to 7 months after completing treatment\u002Ftherapy. Hormonal contraceptives such as birth control pills, patches, implants, or injections are not allowed in patients who are hormone receptor positive;\n17. Patients affiliated to the social security system (or equivalent);\n18. Patient must be willing and able to comply with the protocol for the duration of the trial including scheduled visits, treatment plan, laboratory tests, and examinations including follow-up.\n\nExclusion Criteria:\n\n1. Used of a strong cytochrome P450 (CYP)2C8 inhibitor within 5 half-lives of the inhibitor, or use of a strong CYP3A4 or CYP2C8 inducer within 5 days prior to first dose of study treatment. Use of sensitive CYP3A substrates should be avoided one week before enrollment and during study treatment;\n2. Previous treatment with Tucatinib or Capecitabine;\n3. Severe leukopenia, neutropenia, or thrombocytopena, severe hepatic impairment, severe renal impairment (creatinine clearance below 30mL\u002Fmin)\n4. Recent or concomitant treatment with brivudine ;\n5. Any antiplatelet or curative anticoagulant treatment for blood coagulation disorders;\n6. Severe pre-existing cerebrovascular dysfunction or pathology such as stroke and intra-cerebral hematoma or uncontrolled intracerebral hypertension induced by brain metastasis;\n7. Ventriculoperitoneal or atrial shunt, except if the valve is equipped with an on-off device and that the patient's condition allows for to remain in the off position for 6 hours after each injection of trastuzumab;\n8. Known history of testing positive for HIV or known acquired immunodeficiency syndrome;\n9. Carriers of Hepatitis B or Hepatitis C or have other known chronic liver disease;\n10. Uncontrolled hypertension;\n11. Uncontrolled infection;\n12. Severe dyspnea at rest due to complications of advanced malignancy or requiring supplementary oxygen therapy;\n13. Pregnant or breast-feeding women;\n14. Known prior severe hypersensitivity to tucatinib or compounds chemically or\u002Fand biologically similar or any component in its formulation;\n15. Hypersensitivity to trastuzumab, murine proteins, or to any of the excipients in its formulation;\n16. Known prior severe hypersensitivity to capecitabine or to any of the excipients or fluorouracil;\n17. Known complete dihydropyrimidine dehydrogenase (DPD) deficiency (if applicable);\n18. Inability to swallow tablets or significant gastrointestinal disease which would preclude the adequate oral absorption of medications;\n19. Prior history of other malignancies other than study disease (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 5 years;\n20. Person deprived of their liberty or under protective custody or guardianship;\n21. Participation in another therapeutic trial within the 30 days prior to treatment initiation;\n22. Patients with any other disease or illness, which requires hospitalization or is incompatible with the trial treatment, are not eligible. Patients unwilling or unable to comply with trial obligations for geographic, social, or physical reasons, or who are unable to understand the purpose and procedures of the trial.",{"count":140,"type":20},30,[23],"The goal of this clinical trial is to evaluate the efficacy of tucatinib and capecitabine in combination with intrathecal trastuzumab on overall survival rate at 12 months in HER2-positive metastatic breast cancer (MBC) patients with proven leptomeningeal evolution and requiring intrathecal therapy.",[144,27,145],"Leptomeningeal Metastasis","HER2-positive Metastatic Breast Cancer",[147,27,148,144,149,150,151,145],"Intrathecal injection","Breast Cancer Metastatic","Intrathecal trastuzumab","Capecitabine","Tucatinib","2025-11-14",{"date":154,"type":32},"2025-11-18",{"date":156,"type":32},"2023-12-18",{"date":158,"type":20},"2027-06",{"name":160,"class":39},"UNICANCER",11,{"id":163,"slug":164,"hasResults":11,"nctId":165,"briefTitle":166,"officialTitle":166,"acronym":167,"eligibilityCriteria":168,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":169,"targetDuration":4,"studyType":21,"phases":171,"briefSummary":172,"conditions":173,"keywords":4,"overallStatus":28,"whyStopped":4,"lastUpdateSubmitDate":174,"lastUpdatePostDateStruct":175,"startDateStruct":177,"completionDateStruct":179,"leadSponsor":181,"locationsCount":182},"100447908","phase-1-intrathecal-application-of-pd1-antibody-in-metastatic-solid-tumors-with-leptomeningeal-disease-it-pd1-noa-26-100447908","NCT05112549","Intrathecal Application of PD1 Antibody in Metastatic Solid Tumors With Leptomeningeal Disease (IT-PD1\u002F NOA 26)","IT-PD1","Main Inclusion Criteria:\n\n1. Patient aged ≥ 18 years at the time of signing the informed consent\n2. Existing ability to understand and voluntarily sign an informed consent document prior to any study related assessments\u002Fprocedures\n3. Patient is at \"good risk\" ( NCCN guidelines version 1.2021)\n4. Existence of the following Tumor board protocol confirmations: clinical recommendation for intrathecal therapy and evaluation of trial enrolment \\& statement on the potential necessity of additional systemic treatment of metastatic tumor outside the CNS\n5. Existing ability to adhere to the study visit schedule and other protocol requirements\n6. Existing agreement to refrain from donating blood while on study drug and for 30 days after discontinuation from this study treatment\n7. Karnofsky performance score \\> 50%\n8. Diagnosis of LMD by CSF and\u002For MRI (details see Study protocol)\n9. If radiation therapy was performed please confirm: Participants eligible for IT-PD1 should have completed their radiation therapy due to clinical indication \\> 2 weeks prior to enrollment into the trial\n10. Neurological examination (NANO scale) acc. Nayak et al., 2017 performed\n11. MRI assessment at screening is based on the LANO scorecard acc. to Le Rhun et al., 2019\n12. Existing ability to undergo intrathecal therapy via an intraventricular catheter (e.g. Ommaya reservoir)\n13. Primary tumor tissue for the assessment of PD-1 and PD-L1 is optional at the timepoint of inclusion and enrollment but does need to be shipped before end of the trial.\n14. Existing willingness of female patient of childbearing potential and male patient with female partner of childbearing potential to use highly effective contraceptive methods during treatment and for 150 days (male or female, see SmPC) after the last dose (details see Study protocol)\n\nMain Exclusion Criteria:\n\n1. Women during pregnancy and lactation.\n2. Previous intrathecal nivolumab application.\n3. Patient at \"poor risk\" (NCCN guidelines version 1.2021)\n4. The following differential diagnoses to LMD are exclusion criteria: a. Aseptic, meningitis b. Viral meningitis, c. Bacterial meningitis\n5. History of hypersensitivity to monoclonal antibodies\n6. Participation in other clinical AMG or MDR trials or observation period of competing trials or if there is otherwise a high risk of insurance law issues intervening between two studies and if the participation affects the primary endpoint of the IT-PD1 study. In case of uncertainty, competing insurances must be contacted prior to participation\n7. A clinical condition that in the opinion of the investigator would interfere with the evaluation or interpretation of patient safety or trial results or that would prohibit the understanding of informed consent and compliance with the requirements of the protocol\n8. Any treatment-related toxicities from prior systemic anti-tumor or immune therapy not having resolved to CTCAE version 5.0 grade 1, with the exception of alopecia\n9. Patient with confirmed history of current autoimmune disease\n10. Patients with any disease resulting in permanent immunosuppression or requiring permanent immunosuppressive therapy\n11. Existence of clinically significant active infection (details see study protocol)\n12. Inability to undergo MRI with contrast agent\n13. The underlying primary tumor has not a registered and authorized indication in the European Union for intravenous treatment with Nivolumab, Pembrolizumab or Atezolizumab (details see study protocol). In addition, leptomeningeal disease of solid tumors with a high tumor mutational burden is also eligible.\n14. Existence of abnormal laboratory values for the following values in hematology, coagulation parameters, liver and renal function (details see study protocol)\n15. Patients who have received live or attenuated vaccine therapy used for prevention of infectious disease within 4 weeks of the first IT application of nivolumab\n16. Patients requiring chronic systemic corticosteroid therapy (\\> 10 mg prednisone or equivalent per day) or any other immunosuppressive therapies (including anti-TNF-a therapies)",{"count":170,"type":20},46,[100],"To determine the safety of intrathecal (IT) PD1 antibody for Intrathecal application of PD1 antibody in metastatic solid tumors with leptomeningeal disease of solid tumors.",[27],"2025-03-31",{"date":176,"type":32},"2025-04-03",{"date":178,"type":32},"2021-10-12",{"date":180,"type":20},"2027-09-30",{"name":87,"class":39},9,{"id":184,"slug":185,"hasResults":11,"nctId":186,"briefTitle":187,"officialTitle":187,"acronym":188,"eligibilityCriteria":189,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":190,"targetDuration":4,"studyType":73,"phases":4,"briefSummary":192,"conditions":193,"keywords":4,"overallStatus":28,"whyStopped":4,"lastUpdateSubmitDate":196,"lastUpdatePostDateStruct":197,"startDateStruct":199,"completionDateStruct":201,"leadSponsor":203,"locationsCount":40},"100548185","standardized-clinical-assessment-of-patients-with-leptomeningeal-metastasis-100548185","NCT06417710","Standardized Clinical Assessment of Patients With Leptomeningeal Metastasis","NANO-LM","Inclusion Criteria:\n\n* Adult patients (18 years or more), female or male\n* Histologically confirmed diagnosis of extra-CNS primary solid cancer\n* Diagnosis of leptomeningeal metastases confirmed or probable per EANO ESMO criteria\n* Performance status compatible with enrolment into clinical trials\n* Ability to consent\n* Signed informed consent form from patient\n* Participation in a parallel clinical trial is allowed in this non-interventional study\n\nExclusion Criteria:\n\n* Inability to give informed consent\n* Inability to adhere to recommended follow-up according to the treating physician\n\nVulnerable participants will not be included.",{"count":191,"type":20},200,"The goal of this project is to develop and validate a reproducible scorecard for the neurological assessment of patients with leptomeningeal metastases that can be used in clinical trials including such patients, as well as in clinical practice.",[144,27,194,195],"Leptomeningeal Neoplasms","Leptomeningeal Cancer","2024-05-12",{"date":198,"type":32},"2024-05-16",{"date":200,"type":32},"2022-01-30",{"date":202,"type":20},"2026-12",{"name":204,"class":39},"University of Zurich"]