[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"cns-metastases\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:cns-metastases":29},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,4,0,[8,47,95,126],{"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":31,"overallStatus":35,"whyStopped":4,"lastUpdateSubmitDate":36,"lastUpdatePostDateStruct":37,"startDateStruct":40,"completionDateStruct":42,"leadSponsor":44,"locationsCount":46},"100053855","phase-1-a-study-of-177lu-dtpa-omburtamab-in-children-and-adolescents-with-brain-cancer-or-cancer-that-has-spread-to-the-central-nervous-system-cns-100053855",false,"NCT07698899","A Study of 177Lu-DTPA-Omburtamab in Children and Adolescents With Brain Cancer or Cancer That Has Spread to the Central Nervous System (CNS)","A Phase I Dose Escalation Trial of Compartmental Radioimmunotherapy (cRIT) Using 177Lu-DTPA-omburtamab in Pediatric and Adolescent Patients With Recurrent or Refractory B7H3 Expressing Primary or Metastatic CNS Tumors","Inclusion Criteria:\n\n\\- Disease type:\n\n* Histologically confirmed diagnosis of a tumor that is known to express B7-H3 including but not limited to neuroblastoma, medulloblastoma, rhabdoid tumors, pineoblastoma, retinoblastoma, CNS embryonal tumor, rhabdomyosarcoma, Ewing's sarcoma and ependymoma.\n\n  * Disease status:\n* Patients must have recurrent or refractory disease with CNS parenchymal and\u002For leptomeningeal disease which has been treated with conventional therapies or for which no conventional therapy exists. Measurable or evaluable disease is not required at time of enrollment.\n\n  \\- Age: Patients must be ≥ 3 and \\\u003C 22 years of age at the time of enrollment.\n  * Prior Therapy: The participant must have recovered from acute toxic effects of prior anti-cancer therapies with the following minimum duration from prior therapy:\n* Chemotherapy: Patients must have received their last dose of known myelosuppressive anticancertherapy at least 21 days (3 weeks) prior to enrollment or at least 42 days (6 weeks) if prior nitrosourea.\n* Anti-GD2 monoclonal antibody (neuroblastoma patients): Patients must have received their last dose of anti-GD2 mAb at least 14 days (2 weeks) before enrollment.\n* Radiation: Patients must have had their last fraction of:\n\n  * Craniospinal irradiation, whole brain radiation, or total body irradiation at least 21 days (3 weeks) prior to study enrollment.\n  * Focal radiation to areas of symptomatic metastatic disease at least 14 days (2 weeks) prior to study enrollment.\n* Stem Cell Transplant (SCT): For autologous SCT, 60 days (≥ 2 months) must have elapsed before study enrollment. Patients who have received an autologous hematopoietic stem cell injection to support non- myeloablative therapy (such as 131 I-MIBG) are eligible at any time as long as they meet the other criteria for eligibility. 131\n* I-MIBG therapy or treatment with other radiopharmaceuticals (neuroblastoma 131 patients): A minimum of 42 days (6 weeks) must have elapsed after I-MIBG therapy before start of protocol therapy.\n* Investigational\u002FBiologic Agent (anti-neoplastic): Patient must have recovered from any acute toxicity potentially related to the agent and received their last dose of the investigational or biologic agent ≥ 7 days (1 week) prior to study enrollment.\n* Molecular targeted therapies: Patients must complete a washout period from last therapy that is either 7 days (1 week) or 3 half-lives, whichever is longer.\n\n  * Patients with neurological deficits should have deficits that are stable for a minimum of 7 days (1 week) prior to enrollment.\n  * Patients with seizure disorders may be enrolled if seizures are controlled.\n  * Karnofsky Performance Scale (KPS for \\> 16 years of age) or Lansky Performance Score (LPS for ≤ 16 years of age) assessed within 14 days (2 weeks) prior to study enrollment must be ≥ 50%.\n* Patients who are unable to walk because of neurologic deficits, but who are up in a wheelchair, will be considered ambulatory for the purpose of assessing the performance score.\n\n  * Peripheral absolute neutrophil count (ANC) ≥ 0.5x 109\u002F L (must not have received G-CSF within 7 days (1 week) prior to enrollment or pegfilgrastim within 14 days (2 weeks) prior to enrollment.\n  * Platelet count ≥ 75 x 109\u002F L. Growth factor support (romiplostim or biosimilar) is permitted both prior to and during therapy.\n* For patients with neuroblastoma (regardless of marrow disease status) and other solid tumors known bone marrow infiltration from disease: platelet count ≥ 50 x 109\u002F L (with no platelet transfusion within 7 days prior to study enrollment).\n\n  \\- Adequate Renal Function Defined as:\n\n  \\- A creatinine based on age\u002Fgender as follows: Age; Maximum Serum Creatinine (mg\u002FdL) Male and Female\n\n  1 month to \\\u003C 6 months; 0.4, 0.4 6 months to \\\u003C 1 year; 0.5, 0.5\n  1. to \\\u003C 2 years; 0.6, 0.6\n  2. to \\\u003C 6 years; 0.8, 0.8\n\n  6 to \\\u003C 10 years; 1, 1 10 to \\\u003C 13 years; 1.2. 1.2 13 to \\\u003C 16 years; 1.5, 1.4\n\n  ≥ 16 years; 1.7, 1.4\n  * The threshold creatinine values in this Table were derived from the Schwartz formula for estimating GFR utilizing child length and stature data published by the CDC.\n  * Adequate Liver Function Defined as: - Bilirubin ≤ 1.5 x upper limit of normal (ULN) for age (or ≤ 3 x ULN if Gilbert's syndrome) - SGPT (ALT) \\\u003C 135 U\u002FL. For the purpose of this study, the ULN for SGPT is 45 U\u002FL.\n  * Presence of an appropriate intraventricular access device (e.g., programmable ventriculoperitoneal \\[VP\\] shunt or Ommaya reservoir). Patients are not required to have an existing programmable VP shunt or Ommaya at the time of study enrollment but must be willing and able to undergo a surgical procedure to have one placed prior to cRIT.\n* Note: Patients with an existing intraventricular VP shunt without a programmable component must be willing and able to undergo modification of the shunt.\n\n  * Patients may have active malignancy outside the central nervous system but do not immediately require treatment for systemic disease. Neuroblastoma patients with CNS and systemic disease will only receive 1 dose of cRIT 177Lu- omburtamab while patients with CNS metastases in the absence of systemic disease can receive 2 doses of cRIT 177Lu-omburtamab.\n  * Patients may be on standing steroids, as long as the dosage is either stable or decreasing for at least 7 days (1 week) prior to enrollment.\n  * Human Anti-Mouse Antibody (HAMA) testing will be performed prior to 177Lu-DTPAomburtamab.\n\nExclusion Criteria:\n\n* Patients with obstructive or symptomatic communicating hydrocephalus.\n* Patients with an uncontrolled life-threatening infection.\n* Patients who are pregnant:\n\n  o A negative pregnancy test is required for all women of childbearing age, and appropriate contraception for 3 months after the last dose of 177Lu-DTPAomburtamab is required during the study period.\n* Severe major organ toxicity:\n\n  * Cardiac, pulmonary, and gastrointestinal system toxicity should all be \\\u003C grade 2\n  * Patients with grade 4 hearing loss are excluded","ALL","3 Years","22 Years",{"count":20,"type":21},18,"ESTIMATED","INTERVENTIONAL",[24],"PHASE1","The purpose of this study is to find out whether 177Lu-DPTA-omburtamab is a safe treatment for children and adolescents with recurrent\u002Frefractory medulloblastoma or another type of cancer with CNS metastases.",[27,28,29,30],"Recurrent Medulloblastoma","Refractory Medulloblastoma","CNS Metastases","Central Nervous System Metastasis",[27,28,29,30,32,33,34],"Memorial Sloan Kettering Cancer Center","26-097","177Lu-DTPA-Omburtamab","RECRUITING","2026-07-09",{"date":38,"type":39},"2026-07-13","ACTUAL",{"date":41,"type":39},"2026-07-02",{"date":43,"type":21},"2030-07-02",{"name":32,"class":45},"OTHER",7,{"id":48,"slug":49,"hasResults":11,"nctId":50,"briefTitle":51,"officialTitle":52,"acronym":4,"eligibilityCriteria":53,"healthyVolunteers":11,"sex":16,"minAge":54,"maxAge":4,"enrollmentInfo":55,"targetDuration":4,"studyType":22,"phases":57,"briefSummary":58,"conditions":59,"keywords":72,"overallStatus":35,"whyStopped":4,"lastUpdateSubmitDate":84,"lastUpdatePostDateStruct":85,"startDateStruct":87,"completionDateStruct":89,"leadSponsor":91,"locationsCount":94},"100535595","phase-1-a-phase-11b-study-of-iam1363-in-her2-cancers-100535595","NCT06253871","A Phase 1\u002F1b Study of IAM1363 in HER2 Cancers","A Phase 1\u002F1b Study of IAM1363 in Participants With Advanced Cancers Harboring HER2 Alterations","Key Inclusion Criteria:\n\n* Age ≥ 18 years\n* Have relapsed\u002Frefractory HER2-altered malignancy; for selected cohorts, prospective confirmation of HER2 alteration by central testing is required\n* Have progression of disease after the last systemic therapy, or be intolerant of last systemic therapy\n* Have radiographically measurable disease by RECIST v1.1 and\u002For RANO-BM\n* Eastern Cooperative Oncology Group (ECOG) performance score 0-1\n* Have adequate baseline hematologic, liver and renal function\n* Have left ventricular ejection fraction (LVEF) ≥ 50%\n* Able to swallow oral medication\n\nKey Exclusion Criteria:\n\n* Clinically significant cardiac disease\n* Infection with human immunodeficiency virus (HIV)-1 or HIV-2. Exception: Participants with well-controlled HIV (e.g., CD4 \\>350\u002Fmm3 and undetectable viral load) are eligible\n* Current active liver disease including hepatitis A, hepatitis B , or hepatitis C\n* Refractory nausea and vomiting, malabsorption, external biliary shunt, or significant small bowel resection that would preclude adequate absorption\n* Uncontrolled diabetes\n* History of solid organ transplantation\n* History of Grade ≥2 CNS hemorrhage, or any CNS hemorrhage within 28 days before C1D1\n* Prior history of non-infectious interstitial lung disease (ILD). (Exceptions: participants with prior grade 1 ILD that has completely resolved are eligible)\n* Participants requiring immediate local therapy for brain metastases","18 Years",{"count":56,"type":21},383,[24],"This is a Phase 1\u002F1b open-label, multi-center dose escalation and dose optimization study designed to evaluate the safety and preliminary efficacy of IAM1363 in participants with advanced cancers that harbor HER2 alterations.",[60,61,62,63,64,65,29,66,67,68,69,70,71],"HER2 Mutation-Related Tumors","HER2","HER2-positive Breast Cancer","HER2 + Breast Cancer","Brain Metastases From Solid Tumors","Brain Metastases From HER2 and Breast Cancer","HER2-Positive Solid Tumors","NSCLC (Non-small Cell Lung Cancer)","HER2-positive Bladder Cancer","HER2-positive Colorectal Cancer","HER2 + Gastric Cancer","HER2-positive Gastroesophageal Cancer",[73,74,75,76,77,78,79,80,81,82,61,83],"ERBB2 protein, human","Molecular Targeted Therapy","Genes, erbB-2","Receptor, ErbB-2 \u002F antagonists & inhibitors","Neoplasms \u002F drug therapy","HER2 positive","HER2 overexpressing","HER2 altered","Human epidermal growth factor receptor","ErbB Receptors","brain metastases","2026-06-02",{"date":86,"type":39},"2026-06-04",{"date":88,"type":39},"2024-03-25",{"date":90,"type":21},"2028-12",{"name":92,"class":93},"Iambic Therapeutics, Inc","INDUSTRY",53,{"id":96,"slug":97,"hasResults":11,"nctId":98,"briefTitle":99,"officialTitle":100,"acronym":101,"eligibilityCriteria":102,"healthyVolunteers":11,"sex":16,"minAge":54,"maxAge":4,"enrollmentInfo":103,"targetDuration":4,"studyType":22,"phases":105,"briefSummary":107,"conditions":108,"keywords":111,"overallStatus":35,"whyStopped":4,"lastUpdateSubmitDate":116,"lastUpdatePostDateStruct":117,"startDateStruct":119,"completionDateStruct":121,"leadSponsor":123,"locationsCount":125},"100558549","phase-1-selinexor-with-ice-chemotherapy-in-secondary-central-nervous-system-involving-b-cell-non-hodgkin-lymphoma-100558549","NCT06552559","Selinexor With ICE Chemotherapy in Secondary Central Nervous System Involving B-cell Non-Hodgkin Lymphoma","Phase 1\u002F2 Study of Selinexor With Dexamethasone, Ifosfamide, Carboplatin, and Etoposide in Patients Who Have Secondary Central Nervous System Involvement With Relapsed or Refractory B-cell Non-Hodgkin Lymphoma","SIENA","Inclusion Criteria:\n\n* Patients must have histologically confirmed B-cell NHL with CNS involvement DLBCL including ABC, GCB or PMBCL subtypes Indolent lymphomas transformed to aggressive lymphomas Follicular lymphomas\n* Patients must have received at least one cycles of anthracycline based chemotherapy administered with curative intent\n* Patients must be age ≥18 years.\n* Patients must have at least one site of measurable disease, 1.5 cm in diameter or greater.\n* Patients must have ECOG performance status of 0-2.\n* Patients must have laboratory test results within these ranges: Absolute neutrophil count ≥ 1500\u002Fmm³, Platelet count ≥ 100,000\u002Fmm³, Serum creatinine clearance ≥40 mL\u002Fmin, Total bilirubin ≤ 1.5x ULN (Higher levels are acceptable if these can be attributed to active hemolysis or ineffective erythropoiesis.), AST (SGOT) and ALT (SGPT) ≤ 2x ULN\n* Women of childbearing potential must agree to use dual methods of contraception and have a negative serum pregnancy test prior to selinexor treatment. Male patients must use an effective barrier method of contraception if sexually active with a female of child-bearing potential.\n* Patients must be able to understand and willing to sign a written informed consent document.\n* Patients must be able to adhere to the study visit schedule and other protocol requirements.\n* Patients must not have any serious medical condition, laboratory abnormality, or psychiatric illness that would prevent the subject from signing the informed consent form.\n* Patients must not have any condition, including the presence of laboratory abnormalities, which places the subject at unacceptable risk if he\u002Fshe were to participate in the study or confounds the ability to interpret data from the study.\n* Patients with hepatitis B virus including HBsAg-positive carrier or IgG anti- HBc-positive can be enrolled if they can receive anti-viral prophylaxis\n\nExclusion Criteria:\n\n* Patients cannot fulfill the above-mentioned inclusion criteria\n* Patients with primary CNS lymphoma\n* Patients with a prior history with selinexor",{"count":104,"type":21},37,[24,106],"PHASE2","Secondary involvement of the central nervous system (CNS), such as CNS relapse after treatment or progression during treatment, is a rare but deadly occurrence in patients with B-cell non-Hodgkin lymphoma (NHL), particularly in cases of diffuse large B-cell lymphoma (DLBCL) and transformed follicular lymphoma (FL). Despite the grim prognosis associated with secondary CNS involvement, no definitive treatment strategy exists. Selinexor®, an oral, first-in-class, potent selective inhibitor of nuclear export that binds to XPO1, leads to the nuclear retention of tumor suppressor and growth regulator proteins, as well as topoisomerase II enzymes, thereby restoring their functions. Preclinical studies have also shown that selinexor can sensitize cancer cells to topoisomerase inhibitors, alkylating agents, and steroids. Selinexor has been approved by the Food and Drug Administration for relapsed or refractory DLBCL. We hypothesize that selinexor could work synergistically with ifosfamide (an alkylating agent) and etoposide (a topoisomerase II inhibitor) in the ifosfamide, carboplatin, and etoposide (ICE) regimen. High-dose dexamethasone was added to this regimen to enhance the efficacy of ICE as a salvage regimen for secondary CNS involvement, due to its ability to cross the blood-brain barrier.\n\nThis phase I\u002FII study aims to evaluate the efficacy and safety of selinexor in combination with ifosfamide, carboplatin, etoposide (ICE), and dexamethasone in patients with relapsed or refractory B-cell non-Hodgkin lymphoma with secondary CNS involvement.",[109,110,29],"B-cell Lymphoma Recurrent","B-cell Lymphoma Refractory",[112,113,114,115],"Non-Hodgkin B-cell lymphoma","Secondary CNS involvement","Selinexor","ICE","2026-04-22",{"date":118,"type":39},"2026-04-23",{"date":120,"type":39},"2024-05-01",{"date":122,"type":21},"2028-12-30",{"name":124,"class":45},"Samsung Medical Center",2,{"id":127,"slug":128,"hasResults":11,"nctId":129,"briefTitle":130,"officialTitle":131,"acronym":132,"eligibilityCriteria":133,"healthyVolunteers":11,"sex":16,"minAge":54,"maxAge":4,"enrollmentInfo":134,"targetDuration":4,"studyType":22,"phases":136,"briefSummary":138,"conditions":139,"keywords":4,"overallStatus":35,"whyStopped":4,"lastUpdateSubmitDate":140,"lastUpdatePostDateStruct":141,"startDateStruct":143,"completionDateStruct":145,"leadSponsor":147,"locationsCount":149},"100370882","a-brain-metastases-research-platform-to-tackle-the-challenge-of-cns-metastases-in-solid-tumours-100370882","NCT04109131","A Brain Metastases Research Platform to Tackle the Challenge of CNS Metastases in Solid Tumours","A Brain Metastases Research Platform to Tackle the Challenge of CNS Metastases in Solid Tumours - BrainStorm Program","BrainStorm","Inclusion Criteria:\n\n1. Age ≥ 18 years old\n2. Eastern Cooperative Oncology Group (ECOG) performance status ≤ 2\n3. Female or Male\n4. Eligible for part A: Subjects (from cohorts 1 to 5) with newly diagnosed or up to 24 months from diagnosis of non-CNS metastases. Enrolment of exceptional cases surpassing 24 months from diagnosis will be allowed for up to 20% of subjects enrolled with HER2+ BC (cohort 2) and NSCLC harbouring driver mutations (cohort 3).\n\n   Eligible for part B: Subjects (from cohorts 1 to 7) presenting with a first CNS event and not yet enrolled in the program\n\n   Seven cohorts of subjects are defined in this prospective multicenter study:\n   * Cohort 1: Triple negative breast cancer (TNBC)\n   * Cohort 2: HER 2 positive breast cancer (HER2+ BC)\n   * Cohort 3: Non-small cell lung cancer (NSCLC)\n   * Cohort 4: Small cell lung cancer (SCLC)\n   * Cohort 5: Melanoma\n   * Cohort 6: Other solid tumours (apart from the above mentioned subtypes\n   * Cohort 7: Radiologically or cytologically confirmed leptomeningeal carcinomatosis\n5. Availability of either primary and\u002For non-CNS metastatic archival tumour tissue is mandatory for inclusion.\n6. Willingness to undergo lumbar puncture at diagnosis of CNS metastases unless medical contra-indications\n7. Predicted life expectancy \\> 3 months.\n8. Women of childbearing potential must have a negative urine pregnancy test done within 28 days prior to enrolment\n9. Effective contraception is in place for women of childbearing potential\n10. Completion of all necessary screening procedures within 28 days prior to enrolment.\n11. Signed Informed Consent form (ICF) obtained prior to any study related procedure.\n\n    Inclusion criterion applicable to FRANCE only\n12. Affiliated to the French Social Security System\n\nExclusion Criteria:\n\n1. Pregnant and\u002For lactating women.\n2. Previous or current malignancies of other histologies within the last 2 years, with the exception of in situ carcinoma of the cervix, and adequately treated basal cell or squamous cell carcinoma of the skin.\n3. Subject with a significant medical, neuro-psychiatric, or surgical condition, currently uncontrolled by treatment, which, in the principal investigator's opinion, may interfere with completion of the study.\n\n   Exclusion criterion applicable to FRANCE only\n4. Vulnerable persons according to the article L.1121-6 of the Public Health Code, adults who are the subject of a measure of legal protection or unable to express their consent according to article L.1121-8 of the Public Health Code.",{"count":135,"type":21},600,[137],"NA","Despite some encouraging data, systemic treatment of CNS metastases from solid tumors remains experimental.\n\nBetter knowledge on the evolving epidemiology and biology of BM are key elements for the development of new treatment strategies and identification of promising therapeutic targets for new compounds. Further biological findings may help to better understand the heterogeneity between the primary tumor and the CNS metastases and to identify new targets for therapy thus improving patients' outcome.\n\nIn this context, the Oncodistinct network and the Jules Bordet institute propose to build a multidisciplinary Brain Metastases Clinical Research Platform called BrainStorm. The BrainStorm program will focus on patients with newly diagnosed non-CNS metastatic solid tumors with high risk of developing CNS metastases and will allow building a large clinico pathological database for CNS metastases including ctDNA analyzes from CSF samples. Substudies will be proposed at each time-period with the final objective to develop innovative treatment approaches and strategies.",[29],"2026-01-02",{"date":142,"type":39},"2026-01-06",{"date":144,"type":39},"2020-07-01",{"date":146,"type":21},"2029-01",{"name":148,"class":45},"Jules Bordet Institute",17]