[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"metastatic-malignant-neoplasm-in-the-brain\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:metastatic-malignant-neoplasm-in-the-brain":27},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,19,0,[8,43,67,94,117,142,164,187,209,234,254,275,298,320,343,363,390,411,435],{"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":30,"whyStopped":4,"lastUpdateSubmitDate":31,"lastUpdatePostDateStruct":32,"startDateStruct":35,"completionDateStruct":37,"leadSponsor":39,"locationsCount":42},"100424265","phase-3-testing-if-high-dose-radiation-only-to-the-sites-of-brain-cancer-compared-to-whole-brain-radiation-that-avoids-the-hippocampus-is-better-at-preventing-loss-of-memory-and-thinking-ability-100424265",false,"NCT04804644","Testing if High Dose Radiation Only to the Sites of Brain Cancer Compared to Whole Brain Radiation That Avoids the Hippocampus is Better at Preventing Loss of Memory and Thinking Ability","Phase III Trial of Stereotactic Radiosurgery (SRS) Versus Hippocampal-Avoidant Whole Brain Radiotherapy (HA-WBRT) for Brain Metastases From Small Cell Lung Cancer","Inclusion Criteria:\n\n* Pathologically (histologically or cytologically) proven diagnosis of small cell lung cancer within 5 years of registration. If the original histologic proof of malignancy is greater than 5 years, then pathological (i.e., more recent) confirmation is required (e.g., from a systemic or brain metastasis);\n\n  * Patients with de novo or recurrent small cell lung cancer are permitted.\n* Brain metastases =\\\u003C 4 cm in largest diameter and outside a 5-mm margin around either hippocampus must be visible on contrast-enhanced magnetic resonance imaging (MRI) performed =\\\u003C 21 days prior to study entry.\n\n  * The total tumor volume must be 30 cm\\^3 or less. Lesion volume will be approximated by measuring the lesion's three perpendicular diameters on contrast enhanced, T1-weighted MRI and the product of those diameters will be divided by 2 to estimate the lesion volume (e.g. xyz\u002F2). Alternatively, direct volumetric measurements via slice by slice contouring on a treatment planning software package can be used to calculate the total tumor volume.\n  * Brain metastases can be diagnosed synchronous to the initial diagnosis of small cell lung cancer or metachronous to the initial diagnosis and management of small cell lung cancer.\n  * Brain metastases must be diagnosed on MRI, which will include the following elements:\n\n    * REQUIRED MRI ELEMENTS\n\n      * Post gadolinium contrast-enhanced T1-weighted three-dimensional (3D) spoiled gradient (SPGR). Acceptable 3D SPGR sequences include magnetization prepared 3D gradient recalled echo (GRE) rapid gradient echo (MP-RAGE), turbo field echo (TFE) MRI, BRAVO (Brain Volume Imaging) or 3D Fast FE (field echo). The T1-weighted 3D scan should use the smallest possible axial slice thickness, not to exceed 1.5 mm.\n      * Pre-contrast T1 weighted imaging (3D imaging sequence strongly encouraged).\n      * A minimum of one axial T2 FLAIR (preferred) or T2 sequence is required. This can be acquired as a two dimensional (2D) or 3D image. If 2D, the images should be obtained in the axial plane.\n    * ADDITIONAL RECOMMENDATIONS\n\n      * Recommendation is that an axial T2 FLAIR (preferred) sequence be performed instead of a T2 sequence.\n      * Recommendation is that that pre-contrast 3D T1 be performed with the same parameters as the post-contrast 3D T1.\n      * Recommendation is that imaging be performed on a 3 Tesla (3T) MRI.\n      * Recommendation is that the study participants be scanned on the same MRI instrument at each time point.\n      * Recommendation is that if additional sequences are obtained, these should meet the criteria outlined in Kaufmann et al., 2020.\n      * If additional sequences are obtained, total imaging time should not exceed 60 minutes.\n      * If additional metastases not known at the time of registration\u002Frandomization or seen in the MRI used for eligibility are subsequently found on the radiation therapy (RT) planning MRI such that the total intacranial volume exceeds 30 cm\\^3, the patient is still considered eligible.\n* History\u002Fphysical examination\n* Age \\>= 18\n* Karnofsky performance status of \\>= 70\n* Creatinine clearance \\>= 30 ml\u002Fmin\n* Following the diagnosis of brain metastases, patients can initiate and treat with systemic (chemotherapy and\u002For immunotherapy) before enrollment only if their brain metastases are asymptomatic and not located in eloquent locations (e.g., brainstem, pre-\u002Fpost-central gyrus, visual cortex). However, within 21 days prior to enrollment, brain MRI must be repeated to confirm eligibility.\n\n  * Patients with symptomatic brain metastases and\u002For brain metastases in eloquent locations (e.g., brainstem, pre-\u002Fpost central gyrus, visual cortex) are eligible for enrollment on the trial; however, the specific treatment approach of starting with systemic therapy alone and delaying brain radiation is not recommended for these patients.\n* Concurrent immunotherapy with brain radiation (SRS or HA-WBRT) is permitted.\n* Negative urine or serum pregnancy test (in women of childbearing potential) within 14 days prior to registration. Women of childbearing potential and men who are sexually active must use contraception while on study.\n* Patients may have had prior intracranial surgical resection.\n* Because neurocognitive testing is the primary goal of this study, patients must be proficient in English or French Canadian.\n* The patient must provide study-specific informed consent prior to study entry.\n\n  * Patients with impaired decision-making capacity are not permitted on study.\n* ELIGIBILITY CRITERIA PRIOR TO STEP 2 REGISTRATION\n* The following baseline neurocognitive tests must be completed within 21 days prior to Step 2 registration: HVLT-R, TMT, and COWA. The neurocognitive test will be uploaded into RAVE for evaluation by Dr. Wefel. Once the upload is complete, within 3 business days a notification will be sent via email to the RA to proceed to Step 2.\n\n  * NOTE: Completed baseline neurocognitive tests can be uploaded at the time of Step 1 registration.\n* PRIOR TO STEP 2 REGISTRATION: The following baseline neurocognitive tests must be completed within 21 days prior to Step 2 registration: HVLT-R, TMT, and COWA. The neurocognitive tests will be uploaded into RAVE for evaluation by Dr. Wefel. Once the upload is complete, within 3 business days a notification will be sent via email to the RA to proceed to Step 2.\n\nNOTE: Completed baseline neurocognitive tests can be uploaded at the time of Step 1 registration.\n\nExclusion Criteria:\n\n* Planned infusion of cytotoxic chemotherapy on the same day as SRS or HA-WBRT treatment. Patients may have had prior chemotherapy. Concurrent immunotherapy is permitted.\n\n  * For patients receiving fractionated SRS on an every-other-day basis, planned infusion of cytotoxic chemotherapy is not permitted between SRS treatments.\n* Brainstem metastasis \\> 10 cm\\^3\n* Prior allergic reaction to memantine.\n* Patients with definitive leptomeningeal metastases.\n* Known history of demyelinating disease such as multiple sclerosis.\n* Contraindication to MR imaging such as implanted metal devices that are MRI-incompatible, allergy to MRI contrast that cannot be adequately addressed with pre-contrast medications, or foreign bodies that preclude MRI imaging. (Questions regarding MRI compatibility of implanted objects should be reviewed with the Radiology Department performing the MRI).\n* Current use of (other N-methyl-D-aspartate \\[NMDA\\] antagonists) amantadine, ketamine, or dextromethorphan.\n* Radiographic evidence of hydrocephalus or other architectural change of the ventricular system resulting in significant anatomic distortion of the hippocampus, including placement of external ventricular drain or ventriculoperitoneal shunt.\n\n  * Mild cases of hydrocephalus not resulting in significant anatomic distortion of the hippocampus are permitted.\n* Prior radiotherapy to the brain, including SRS, WBRT, or prophylactic cranial irradiation (PCI).","ALL","18 Years",{"count":19,"type":20},200,"ESTIMATED","INTERVENTIONAL",[23],"PHASE3","This phase III trial compares the effect of stereotactic radiosurgery to standard of care memantine and whole brain radiation therapy that avoids the hippocampus (the memory zone of the brain) for the treatment of small cell lung cancer that has spread to the brain. Stereotactic radiosurgery is a specialized radiation therapy that delivers a single, high dose of radiation directly to the tumor and may cause less damage to normal tissue. Whole brain radiation therapy delivers a low dose of radiation to the entire brain including the normal brain tissue. Hippocampal avoidance during whole-brain radiation therapy (HA-WBRT) decreases the amount of radiation that is delivered to the hippocampus which is a brain structure that is important for memory. The drug, memantine, is also often given with whole brain radiotherapy because it may decrease the risk of side effects related to thinking and memory. Stereotactic radiosurgery may decrease side effects related to memory and thinking compared to standard of care HA-WBRT plus memantine.",[26,27,28,29],"Metastatic Lung Small Cell Carcinoma","Metastatic Malignant Neoplasm in the Brain","Recurrent Lung Small Cell Carcinoma","Stage IV Lung Cancer AJCC v8","RECRUITING","2026-06-30",{"date":33,"type":34},"2026-07-01","ACTUAL",{"date":36,"type":34},"2021-06-08",{"date":38,"type":20},"2030-07-01",{"name":40,"class":41},"NRG Oncology","OTHER",231,{"id":44,"slug":45,"hasResults":11,"nctId":46,"briefTitle":47,"officialTitle":48,"acronym":4,"eligibilityCriteria":49,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":50,"targetDuration":4,"studyType":21,"phases":52,"briefSummary":54,"conditions":55,"keywords":4,"overallStatus":30,"whyStopped":4,"lastUpdateSubmitDate":58,"lastUpdatePostDateStruct":59,"startDateStruct":60,"completionDateStruct":62,"leadSponsor":64,"locationsCount":66},"100468215","phase-4-an-investigational-scan-64cu-dota-trastuzumab-petmri-in-imaging-patients-with-her2-breast-cancer-with-brain-metastasis-100468215","NCT05376878","An Investigational Scan (64Cu-DOTA-Trastuzumab PET\u002FMRI) in Imaging Patients With HER2+ Breast Cancer With Brain Metastasis","Pilot Study to Evaluate 64Cu-DOTA-Trastuzumab Imaging in Patients With HER2+ Breast Cancer With Brain Metastatsis Treated With Fam-Trastuzumab Deruxtecan","Inclusion Criteria:\n\n* Documented informed consent of the participant and\u002For legally authorized representative\n* Women with documented metastatic HER2 positive breast cancer (American Society of Clinical Oncology \\[ASCO\\] College of American Pathologist \\[CAP\\] guidelines) who have brain metastases\n* Age \\> 18 years\n* Eastern Cooperative Oncology Group (ECOG) 0-2\n* Patients with leptomeningeal disease will be considered eligible\n* Planned therapy with fam-trastuzumab deruxtecan\n* Left ventricular ejection fraction (LVEF) \\> 50%\n* Absolute neutrophil count (ANC) \\> 1.5 x 10\\^9\u002FL\n* Platelets \\> 100 x 10\\^9\u002FL\n* Hemoglobin \\> 9 g\u002FdL\n* Total (T.) bilirubin \\\u003C 3 x upper limit of normal (ULN)\n* Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) \\\u003C 5 x ULN\n* Creatinine clearance \\> 30 ml\u002Fmin (by Cockcroft-Gault formula)\n* Activated partial thromboplastin time (aPTT) \\\u003C 1.5 x ULN\n* Prior therapy for central nervous system (CNS) disease is allowed, but at least 1 lesion \\> 1.5 cm is evident on MRI\n\nExclusion Criteria:\n\n* Need for immediate local intervention for brain metastases\n* Noninfectious interstitial lung disease or pneumonitis requiring glucocorticoids\n* Clinically significant corneal disease\n* Myocardial infarction \\\u003C 6 months before, congestive heart failure (CHF), unstable angina, or serious cardiac arrhythmia",{"count":51,"type":20},10,[53],"PHASE4","This clinical trial examines an investigational scan (64Cu-DOTA-trastuzumab positron emission tomography \\[PET\\]\u002Fmagnetic resonance imaging \\[MRI\\]) in imaging patients with HER2+ breast cancer that has spread to the brain (brain metastasis). Diagnostic procedures, such as 64Cu-DOTA-trastuzumab PET\u002FMRI, may help find HER2+ breast cancer that has spread to the brain and determine whether cancer in the brain takes up trastuzumab, which may predict for response to trastuzumab deruxtecan (the standard of care chemotherapy).",[56,57,27],"Anatomic Stage IV Breast Cancer AJCC v8","Metastatic Breast Carcinoma","2026-06-29",{"date":33,"type":34},{"date":61,"type":34},"2022-12-21",{"date":63,"type":20},"2027-04-27",{"name":65,"class":41},"City of Hope Medical Center",1,{"id":68,"slug":69,"hasResults":11,"nctId":70,"briefTitle":71,"officialTitle":72,"acronym":4,"eligibilityCriteria":73,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":74,"targetDuration":4,"studyType":21,"phases":76,"briefSummary":77,"conditions":78,"keywords":4,"overallStatus":30,"whyStopped":4,"lastUpdateSubmitDate":85,"lastUpdatePostDateStruct":86,"startDateStruct":88,"completionDateStruct":90,"leadSponsor":92,"locationsCount":93},"100554543","phase-3-testing-longer-duration-radiation-therapy-versus-the-usual-radiation-therapy-in-patients-with-cancer-that-has-spread-to-the-brain-100554543","NCT06500455","Testing Longer Duration Radiation Therapy Versus the Usual Radiation Therapy in Patients With Cancer That Has Spread to the Brain","Phase III Trial of Single Fraction Stereotactic Radiosurgery (SRS) Versus Fractionated SRS (FSRS) for Intact Brain Metastases","Inclusion Criteria:\n\n* Pathologically (histologically or cytologically) proven diagnosis of one of the following solid tumor malignancies within 5 years prior to registration:\n\n  * Non-small cell lung cancer\n  * Melanoma\n  * Breast cancer\n  * Renal cell carcinoma\n  * Gastrointestinal cancer\n  * If the original histologic proof of malignancy is greater than 5 years, then more recent pathologic confirmation (e.g., from a systemic site or brain metastasis) or unequivocal imaging confirmation of extracranial metastatic disease (e.g. CT of the chest\u002Fabdomen\u002Fpelvis, positron emission tomography \\[PET\\]\u002FCT, etc.) is required\n* Patients must have at least 1 and up to 8 total intact brain metastases detected on a contrast-enhanced MRI performed ≤ 21 days prior to registration\n* At least 1 of the up to 8 lesions must be a study eligible lesion, defined as lesion with a maximum diameter as measured on any orthogonal plane (axial, sagittal, coronal) of ≥ 1.0 cm and ≤ 3.0 cm\n* All brain metastases must be located outside of the brainstem and ≥ 5 mm from the optic nerves or optic chiasm and ≤ 3.0 cm in maximum dimension\n\n  * Note: brainstem metastases per the MRI within 21 days of registration are an exclusion criterion; however, if the MRI used for treatment planning performed within 7 days of SRS\u002FFSRS reveals a brainstem metastasis, the patient remains eligible if the patient is considered an appropriate radiosurgery candidate per the local investigator\n* Patients must have a diagnosis-specific graded prognostic assessment ≥ 1.5\n* No more than 2 lesions planned for resection if clinically indicated\n* No known leptomeningeal disease (LMD)\n\n  * Note: For the purposes of exclusion, LMD is a clinical diagnosis, defined as positive cerebrospinal fluid (CSF) cytology and\u002For unequivocal radiologic or clinical evidence of leptomeningeal involvement. Patients with leptomeningeal symptoms in the setting of leptomeningeal enhancement by imaging (MRI) would be considered to have LMD even in the absence of positive CSF cytology. In contrast, an asymptomatic or minimally symptomatic patient with mild or nonspecific leptomeningeal enhancement (MRI) would not be considered to have LMD. In that patient, CSF sampling is not required to formally exclude LMD, but can be performed at the investigator's discretion based on level of clinical suspicion\n* Age ≥ 18 years\n* Karnofsky performance status (KPS) ≥ 60\n* Negative urine or serum pregnancy test (in persons of childbearing potential) within 14 days prior to registration. Childbearing potential is defined as any person who has experienced menarche and who has not undergone surgical sterilization (hysterectomy or bilateral oophorectomy) or who is not postmenopausal\n* No prior radiotherapy to the brain (partial or whole brain irradiation, SRS, FSRS, or prophylactic cranial irradiation \\[PCI\\])\n* New York Heart Association Functional Classification II or better (NYHA Functional Classification III\u002FIV are not eligible) (Note: Patients with known history or current symptoms of cardiac disease, or history of treatment with cardiotoxic agents, should have a clinical risk assessment of cardiac function using the New York Heart Association Functional Classification)\n* No active infection currently requiring intravenous (IV) antibiotic management\n* No hepatic insufficiency resulting in clinical jaundice and\u002For coagulation defects\n* No chronic obstructive pulmonary disease exacerbation or other acute respiratory illness precluding study therapy",{"count":75,"type":20},269,[23],"This phase III trial compares the effectiveness of fractionated stereotactic radiosurgery (FSRS) to usual care stereotactic radiosurgery (SRS) in treating patients with cancer that has spread from where it first started to the brain. Radiation therapy uses high energy x-rays to kill tumor cells and shrink tumors. FSRS delivers a high dose of radiation to the tumor over 3 treatments. SRS is a type of external radiation therapy that uses special equipment to position the patient and precisely give a single large dose of radiation to a tumor. FSRS may be more effective compared to SRS in treating patients with cancer that has spread to the brain.",[56,57,79,80,27,81,82,83,29,84],"Metastatic Digestive System Carcinoma","Metastatic Lung Non-Small Cell Carcinoma","Metastatic Malignant Solid Neoplasm","Metastatic Melanoma","Metastatic Renal Cell Carcinoma","Stage IV Renal Cell Cancer AJCC v8","2026-06-22",{"date":87,"type":34},"2026-06-25",{"date":89,"type":34},"2024-12-12",{"date":91,"type":20},"2028-06-30",{"name":40,"class":41},270,{"id":95,"slug":96,"hasResults":11,"nctId":97,"briefTitle":98,"officialTitle":99,"acronym":4,"eligibilityCriteria":100,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":101,"targetDuration":4,"studyType":21,"phases":103,"briefSummary":104,"conditions":105,"keywords":4,"overallStatus":30,"whyStopped":4,"lastUpdateSubmitDate":107,"lastUpdatePostDateStruct":108,"startDateStruct":110,"completionDateStruct":112,"leadSponsor":114,"locationsCount":116},"100343329","phase-3-pre-operative-or-post-operative-stereotactic-radiosurgery-in-treating-patients-with-operative-metastatic-brain-tumors-100343329","NCT03750227","Pre-Operative or Post-Operative Stereotactic Radiosurgery in Treating Patients With Operative Metastatic Brain Tumors","Pre-Operative vs. Post-Operative Stereotactic Radiosurgery for Operative Metastatic Brain Tumors","Inclusion Criteria:\n\n* Age \\>= 18 years\n* Histological or cytological confirmation of solid tumor malignancy and\u002For clinical history of known or suspected metastatic disease with an intraparenchymal brain tumor consistent with brain metastasis based on clinical and radiologic findings\n* Clinical indication for surgical resection of one brain metastasis based on neurosurgery recommendation and patient deemed a surgical candidate\n* Clinical indication and plan for stereotactic radiosurgery to all known brain lesions requiring treatment (=\\\u003C 10 metastases)\n* Eastern Cooperative Oncology Group (ECOG) performance status (PS) =\\\u003C 2\n* Provide written informed consent or have a legally authorized representative who is responsible for the care and well-being of the potential study participant, provide consent\n* Willing to continue follow-up visits, either at the enrolling institution or with a local medical doctor as clinically appropriate, and according to the study timeline. Clinical notes and digital copies of imaging must be provided to the enrolling site if follow-up is done externally\n\nExclusion Criteria:\n\n* Any of the following:\n\n  * Pregnant women\n  * Nursing women\n  * Men or women of childbearing potential who are unwilling to employ adequate contraception\n* Co-morbid systemic illnesses or other severe concurrent disease which, in the judgment of the investigator, would make the patient inappropriate for entry into this study or interfere significantly with the proper assessment of safety and toxicity of the prescribed regimens\n* Immunocompromised patients and patients known to be human immunodeficiency virus (HIV) positive and currently receiving antiretroviral therapy. \\* NOTE: Patients known to be HIV, but without clinical evidence of an immunocompromised state, are eligible for this trial\n* Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness\u002Fsocial situations that would limit compliance with study requirements\n* Prior open neurosurgery for malignancy\n* Known or clinically suspected primary germ cell tumor, small cell carcinoma, or lymphoma\n* History of whole brain radiation therapy (WBRT)\n* Known allergy to gadolinium, pacemaker, or other contraindication such as metal implant that is not safe for MRI. Patients with MRI-compatible implants including MRI compatible pacemakers are eligible\n* Leptomeningeal metastasis\u002Fdisease\n* A brain metastasis that is located =\\\u003C 5 mm of the optic chiasm\n* Any brain metastasis \\> 5 cm in size\n* \\> 10 brain metastases\n* Indication for surgical resection of \\>= 2 brain metastases\n* Indication for long-term (anticipated greater than 4 weeks) 4 mg dexamethasone equivalent of steroids or bevacizumab\n* Actively enrolled on another brain metastases trial that is assessing the efficacy of either radiation or surgical interventions",{"count":102,"type":20},140,[23],"This phase III trial studies the side effects and how well stereotactic radiosurgery (SRS) works before or after surgery in patients with tumors that has spread to the brain or that can be removed by surgery. Stereotactic radiosurgery is a specialized radiation therapy that delivers a single, high dose of radiation directly to the tumor and may cause less damage to normal tissue.",[106,27],"Malignant Solid Neoplasm","2026-06-12",{"date":109,"type":34},"2026-06-16",{"date":111,"type":34},"2018-11-19",{"date":113,"type":20},"2030-11-08",{"name":115,"class":41},"Mayo Clinic",4,{"id":118,"slug":119,"hasResults":11,"nctId":120,"briefTitle":121,"officialTitle":122,"acronym":4,"eligibilityCriteria":123,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":124,"targetDuration":4,"studyType":21,"phases":126,"briefSummary":129,"conditions":130,"keywords":4,"overallStatus":30,"whyStopped":4,"lastUpdateSubmitDate":133,"lastUpdatePostDateStruct":134,"startDateStruct":136,"completionDateStruct":138,"leadSponsor":140,"locationsCount":66},"100484469","phase-1-natural-killer-cell-therapy-ud-tgfbetai-nk-cells-and-temozolomide-for-the-treatment-of-stage-iv-melanoma-metastatic-to-the-brain-100484469","NCT05588453","Natural Killer Cell Therapy (UD TGFbetai NK Cells) and Temozolomide for the Treatment of Stage IV Melanoma Metastatic to the Brain","A Phase I\u002FII Study of Ex-Vivo Expanded Allogeneic Universal Donor (UD) TGFbi NK Cell Infusions in Combination With Temozolomide as a Lymphodepleting Agent in Patients With Melanoma Metastatic to the Brain","Inclusion Criteria:\n\n* Histologically confirmed melanoma with stage IV disease\n* Radiologically confirmed brain metastasis (n \\>= 1) with at least one measurable central nervous system (CNS) lesion \\>= 10 mm on T1-weighted gadolinium enhanced magnetic resonance imaging (MRI) and unequivocal evidence of progression\n* No indication for stereotactic radiotherapy\n* At least 4 weeks from any anticancer treatment (cytotoxic chemotherapy, signal transduction inhibitors, immunotherapy or radiation)\n* Absolute neutrophil count (ANC) 1 x 10\\^9\u002FL\n* Platelets \\> 100,000\u002FL\n* Hemoglobin (Hgb) \\>= 10 g\u002FdL\n* Creatinine =\\\u003C 1.5 x upper limit of normal (ULN)\n* Albumin \\>= 2.5 g\u002FdL\n* Serum bilirubin \\\u003C 1.5 x ULN unless due to Gilbert's syndrome\n* Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) \\\u003C 5 x ULN if documented liver metastases or \\\u003C 3 X ULN without liver metastasis\n* \\> 18 years old (y\u002Fo)\n* Eastern Cooperative Oncology Group (ECOG) performance status of 0-2\n* Females of reproductive age must agree to the use of an effective contraceptive method while on treatment, beginning 2 weeks before the first dose of investigational product and for 28 days after the final dose of investigational product for women. Males able to father a child must practice adequate methods of contraception or completely abstain from intercourse from the first dose of investigational treatment until one week after the final dose of investigational treatment\n* Women of childbearing potential must have a negative serum pregnancy test within 14 days of enrollment and\u002For urine pregnancy test 48 hours prior to the administration of the first study treatment\n* Patient information and written informed consent form signed\n\nExclusion Criteria:\n\n* Planned or concurrent systemic treatment or radiation therapy\n* If requiring corticosteroids for cerebral edema, patients must be on a stable dose. Lowest dose of steroids needed to control CNS edema is recommended. Doses above 4 mg daily need to be cleared by principal investigator (PI) of the study\n* Known contra-indication to MRI\n* Patients with non-melanoma malignancies are excluded unless a complete remission has been achieved at least 3 years prior to study entry and no additional therapy is required or anticipated during the study period (exceptions include: non-melanoma skin cancers, in situ bladder cancer, in situ gastric cancer, in situ colon cancers, in situ cervical cancers\u002Fdysplasia, or in situ breast carcinoma)\n* Patients with other concurrent severe and\u002For uncontrolled medical disease which could compromise participation in the study, such as:\n\n  * Active infection\n  * Current active hepatic or renal disease\n  * Pregnant women, women who are likely to become pregnant or are breastfeeding\n  * Patients with significantly altered mental status prohibiting the understanding of the study or with psychological, familial, sociological, or geographical conditions potentially hampering ability to consent, compliance with the study protocol, and follow-up schedule; those conditions should be discussed with the patient before remigration in the trial\n  * Patients who received any other investigational drugs within the 30 days prior to screening visit\n  * Leptomeningeal metastases diagnosed by MRI\n  * Inclusion in another therapeutic protocol within 30 days\n  * If steroids are necessary to control symptoms related to CNS metastases, patients should be on the lowest dose of steroids necessary to control symptoms",{"count":125,"type":20},24,[127,128],"PHASE1","PHASE2","This phase I\u002FII trial tests the safety, side effects, and best dose of universal donor UD TGFbetai natural killer (NK) cells, and whether UD TGFbetai NK cells with temozolomide works to shrink tumors in patients with stage IV melanoma that has spread to the brain (metastatic to the brain). NK cells are immune cells that contribute to anti-tumor immunity by recognizing and destroying transformed or stressed cells. Temozolomide is in a class of medications called alkylating agents. It works by slowing or stopping the growth of cancer cells in the body. Giving UD TGFbetai NK cell and temozolomide may work better in treating patients with stage IV melanoma.",[131,27,82,132],"Clinical Stage IV Cutaneous Melanoma AJCC v8","Pathologic Stage IV Cutaneous Melanoma AJCC v8","2026-06-09",{"date":135,"type":34},"2026-06-11",{"date":137,"type":34},"2023-03-01",{"date":139,"type":20},"2027-04-15",{"name":141,"class":41},"Kari Kendra",{"id":143,"slug":144,"hasResults":11,"nctId":145,"briefTitle":146,"officialTitle":147,"acronym":4,"eligibilityCriteria":148,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":149,"targetDuration":4,"studyType":21,"phases":151,"briefSummary":152,"conditions":153,"keywords":4,"overallStatus":155,"whyStopped":4,"lastUpdateSubmitDate":156,"lastUpdatePostDateStruct":157,"startDateStruct":159,"completionDateStruct":161,"leadSponsor":163,"locationsCount":66},"100641026","phase-1-a-pet-imaging-agent-64cu-dota-pembrolizumab-for-determining-treatment-response-among-patients-with-stage-iv-non-small-cell-lung-cancer-receiving-pembrolizumab-100641026","NCT07619599","A PET Imaging Agent (64Cu-DOTA-Pembrolizumab) for Determining Treatment Response Among Patients With Stage IV Non-small Cell Lung Cancer Receiving Pembrolizumab","Pilot Study of 64Cu-DOTA Pembrolizumab (64CDP) in Patients Receiving Stereotactic Body Radiation Therapy (SBRT) for Oligo-Progressive Non-Small Cell Lung Cancer (NSCLC)","Inclusion Criteria:\n\n* Documented informed consent of the participant and\u002For legally authorized representative\n\n  * Assent, when appropriate, will be obtained per institutional guidelines\n* Age: ≥ 18 years\n* Eastern Cooperative Oncology Group (ECOG) ≤ 2\n* Histologically confirmed stage IV non-small cell lung cancer\n* Patients on single-agent pembrolizumab, who have been referred for SBRT for or oligo-progressive disease. A maximum of 6 sites will be allowed to receive SBRT on protocol\n* Patients must have sites that are amenable to SBRT that are located in lymph nodes, bone\u002Fspine, or lung\n* Brain metastases or cases with intra-cranial progression are allowed, but an additional extra-cranial site planned for SBRT is required\n* Absolute neutrophil count (ANC) ≥ 1,000\u002Fmm\\^3\n* Platelets ≥ 50,000\u002Fmm\\^3\n\n  * NOTE: Platelet transfusions are not permitted within 14 days of platelet assessment\n* Total bilirubin ≤ 1.5 X upper limit of normal (ULN)\n* Aspartate aminotransferase (AST) ≤ 3.0 x ULN\n* Alanine aminotransferase (ALT) ≤ 3.0 x ULN\n* Creatinine clearance of ≥ 30 mL\u002Fmin per 24 hour urine test or the Cockcroft-Gault formula\n* Women of childbearing potential (WOCBP): negative urine or serum pregnancy test\n\n  * If the urine test is positive or cannot be confirmed as negative, a serum pregnancy test will be required\n* Agreement by females and males of childbearing potential\\* to use an effective method of birth control or abstain from heterosexual activity for the course of the study through at least 6 months after the last dose of protocol therapy\n\n  * Childbearing potential defined as not being surgically sterilized (men and women) or have not been free from menses for \\> 1 year (women only)\n\nExclusion Criteria:\n\n* Patient planned to stop pembrolizumab at time of referral for SBRT\n* Vaccination with live attenuated vaccines within 4 weeks of study agent administration except forthcoming coronavirus disease 2019 (COVID-19) and flu vaccines\n* Subject is currently using or has used immunosuppressive medication within 14 days prior to the study agent administration with the exception of:\n\n  * Intranasal, topical, inhaled, or local steroid injections (e.g., intra-articular injection)\n  * Chronic systemic corticosteroids at physiologic doses not to exceed 5 mg\u002Fday of prednisone or equivalent\n  * Steroids as premedication for hypersensitivity reactions (e.g., infusion-related reactions, CT scan premedication)\n* History of allergic reactions attributed to compounds of similar chemical or biologic composition to study agent\n* Clinically significant uncontrolled illness\n* Infection requiring systemic antibiotic therapy within 14 days prior to start of study treatment\n* Patient unable to tolerate PET scan even with anxiolytic medications\n* Other active metastatic malignancy. Patients with a prior or concurrent malignancy whose natural history or treatment does not have the potential to interfere with the safety or efficacy assessment of the investigational regimen are eligible for this trial\n* Females only: Pregnant or breastfeeding\n* Any other condition that would, in the Investigator's judgment, contraindicate the patient's participation in the clinical study due to safety concerns with clinical study procedures\n* Prospective participants who, in the opinion of the investigator, may not be able to comply with all study procedures (including compliance issues related to feasibility\u002Flogistics)",{"count":150,"type":20},6,[127],"This phase I trial studies the safety and side effects of a new positron emission tomography (PET) imaging agent called 64Cu-DOTA-pembrolizumab to see how well it works in determining treatment response for patients with stage IV non-small cell lung cancer (NSCLC) already receiving pembrolizumab. 64Cu-DOTA-pembrolizumab consists of a monoclonal antibody, pembrolizumab, that binds to a protein called PD-1 that is expressed on tumor cells. PET scans can then visualize the tumor cells using 64Cu, a radioactive substance. 64Cu-DOTA-pembrolizumab PET scans may be safe and useful to doctors in telling the difference between tumors that are still growing and areas that are not growing in patients with stage IV NSCLC receiving pembrolizumab treatment.",[80,27,154,29],"Oligoprogressive Lung Non-Small Cell Carcinoma","NOT_YET_RECRUITING","2026-05-26",{"date":158,"type":34},"2026-06-02",{"date":160,"type":20},"2026-09-14",{"date":162,"type":20},"2028-12-22",{"name":65,"class":41},{"id":165,"slug":166,"hasResults":11,"nctId":167,"briefTitle":168,"officialTitle":169,"acronym":4,"eligibilityCriteria":170,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":171,"targetDuration":4,"studyType":21,"phases":173,"briefSummary":175,"conditions":176,"keywords":4,"overallStatus":30,"whyStopped":4,"lastUpdateSubmitDate":177,"lastUpdatePostDateStruct":178,"startDateStruct":180,"completionDateStruct":182,"leadSponsor":184,"locationsCount":186},"100299898","neurocognition-in-patients-with-multiple-brain-metastases-treated-with-radiosurgery-100299898","NCT03184038","Neurocognition in Patients With Multiple Brain Metastases Treated With Radiosurgery","Neurocognition in Patients With Multiple Brain Metastases Treated With Radiosurgery: A Phase II Study","Inclusion Criteria:\n\n* Pathologically proven solid tumor malignancy (except for small cell lung cancer \\[SCLC\\], germ cell tumor)\n* Karnofsky performance status \\>= 60\n* 1 to 10 brain metastases (mets) (no more than two lesions and\u002For cavities \\>= 3 cm in maximum diameter)\n* Maximum diameter of brain metastasis or resection cavity is 6 cm\n* Serum creatinine =\\\u003C 3 mg\u002FdL and creatinine clearance \\>= 30 ml\u002Fmin\n* Patients must have the psychological ability and general health that permits completion of the study requirements and required follow up; patients must be willing to complete neurocognitive assessments at pre-specified time points outlined in the protocol\n* Women of childbearing potential must have a negative beta-human chorionic gonadotropin (HCG) pregnancy test documented within 21 days prior to registration\n* Women of child-bearing potential and men must agree to use adequate contraception (hormonal or barrier method of birth control; abstinence) prior to study entry and for 4 months after last dose\n* Patient able to provide his\u002Fher own written informed consent and speak English\n\nExclusion Criteria:\n\n* Patient with diagnosis of glioma, or other World Health Organization (WHO) grade II - IV primary brain tumor\n* Prior brain surgery =\\\u003C 14 days prior to enrollment\n* Planned chemotherapy during radiosurgery\n* Leptomeningeal metastases\n* Intractable seizures while on adequate anticonvulsant therapy-more than 1 seizure per week for the past 2 months\n* Pregnant women",{"count":172,"type":20},90,[174],"NA","This phase II trial studies the neurological function in patients with multiple brain metastases undergoing stereotactic radiosurgery (SRS) or stereotactic body radiation therapy (SBRT). Stereotactic body radiation therapy uses special equipment to position a patient and deliver radiation to tumors with high precision. This method can kill tumor cells with fewer doses over a shorter period and cause less damage to normal tissue. Assessment of neurocognitive function may help show that SRS preserves neurological function in patients with multiple brain metastases better than SBRT.",[27,81],"2026-05-20",{"date":179,"type":34},"2026-05-22",{"date":181,"type":34},"2017-02-21",{"date":183,"type":20},"2026-09-30",{"name":185,"class":41},"Sidney Kimmel Comprehensive Cancer Center at Thomas Jefferson University",2,{"id":188,"slug":189,"hasResults":11,"nctId":190,"briefTitle":191,"officialTitle":192,"acronym":4,"eligibilityCriteria":193,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":194,"targetDuration":4,"studyType":21,"phases":196,"briefSummary":197,"conditions":198,"keywords":4,"overallStatus":30,"whyStopped":4,"lastUpdateSubmitDate":201,"lastUpdatePostDateStruct":202,"startDateStruct":203,"completionDateStruct":205,"leadSponsor":207,"locationsCount":66},"100266956","electrocorticography-in-mapping-functional-brain-areas-during-surgery-in-patients-with-brain-tumors-100266956","NCT02754544","Electrocorticography in Mapping Functional Brain Areas During Surgery in Patients With Brain Tumors","Pilot Investigation of Using Electrocorticogram (ECoG) in Predicting Eloquent Cortex and Post-Operative Functional Outcomes in Patients With Brain Tumors","Inclusion Criteria:\n\n* Patients undergoing a tumor resection at the University of Texas M. D. Anderson Cancer Center for a newly diagnosed as well as recurrent primary or metastatic brain tumor located in or adjacent to motor and\u002For speech brain areas\n* Patients \\>= 18 years of age\n* Signed informed consent\n\nExclusion Criteria:\n\n* Patients with significant neurological motor deficits of the upper extremities, and\u002For speech deficits, which would preclude them from performing the while awake intra-operative tasks at the discretion of the principal investigator (PI)\n* Patients who have impaired vision and\u002For hearing and whose performance could affect the study will be excluded at the discretion of the PI",{"count":195,"type":20},75,[174],"This pilot clinical trial studies how well electrocorticography works in mapping functional brain areas during surgery in patients with brain tumors. Using a larger than the standard mapping grid currently used during brain tumor surgery or a high-definition grid for electrocorticogram brain mapping may help doctors to better identify which areas of the brain are active during specific limb movement and speech during surgery in patients with brain tumors.",[199,27,200],"Brain Neoplasm","Recurrent Brain Neoplasm","2026-05-18",{"date":177,"type":34},{"date":204,"type":34},"2016-07-22",{"date":206,"type":20},"2028-01-01",{"name":208,"class":41},"M.D. Anderson Cancer Center",{"id":210,"slug":211,"hasResults":11,"nctId":212,"briefTitle":213,"officialTitle":214,"acronym":4,"eligibilityCriteria":215,"healthyVolunteers":11,"sex":216,"minAge":17,"maxAge":4,"enrollmentInfo":217,"targetDuration":4,"studyType":21,"phases":219,"briefSummary":220,"conditions":221,"keywords":4,"overallStatus":30,"whyStopped":4,"lastUpdateSubmitDate":224,"lastUpdatePostDateStruct":225,"startDateStruct":227,"completionDateStruct":229,"leadSponsor":231,"locationsCount":233},"100389274","phase-2-dendritic-cell-vaccines-against-her2her3-and-pembrolizumab-for-the-treatment-of-brain-metastasis-from-triple-negative-breast-cancer-or-her2-breast-cancer-100389274","NCT04348747","Dendritic Cell Vaccines Against Her2\u002FHer3 and Pembrolizumab for the Treatment of Brain Metastasis From Triple Negative Breast Cancer or HER2+ Breast Cancer","A Phase IIa Study of Dendritic Cell Vaccines Against Her2\u002FHer3 and Pembrolizumab in Patients With Asymptomatic Brain Metastasis From Triple Negative Breast Cancer (TNBC) or HER2+ Breast Cancer (HER2+BC) or Hormone Receptor Positive (HR+) Breast Cancer.","Inclusion Criteria:\n\n* female participant is eligible to participate if she is not pregnant,not breastfeeding, and at least one of the following conditions applies:\n\n  * Not a woman of childbearing potential (WOCBP)\n  * A WOCBP who agrees to follow contraceptive guidance\n* WOCBP must agree to use acceptable birth control methods for the duration of the study and until persistence of the study drug is no longer detected in the peripheral blood:this may be a period of several years. Methods for acceptable birth control include: condoms, diaphragm or cervical cap with spermicide, intrauterine device, and hormonal contraception; it is recommended that a combination of two methods be used. NOTE: If the risk of conception exists, patients must agree to use highly effective contraception throughout the study and for at least two years following the last study treatment administration\n* Negative serum and highly sensitive urine pregnancy test(s):\n* At initial screening prior to eligibility confirmation\n* within 72 hours prior to leukapheresis if \\>72 hours have passed between screening test and the Leukapheresis visit\n* Pregnancy testing will be performed for WOCBP and interpreted prior to every cycle of pembrolizumab (Initial Treatment Phase);\n* at the End of Treatment (EOT) Assessment; and\n* whenever pregnancy is otherwise suspected. Note: In the event that 72 hours have elapsed between the screening pregnancy test and leukapheresis, another pregnancy test must be performed and must be negative in order for subject to undergo leukapheresis\n* Histologically or cytologically confirmed diagnosis of triple negative breast cancer (TNBC) (estrogen receptor \\[ER\\] =\\\u003C 1%, progesterone receptor \\[PR\\] =\\\u003C 1% HER2 negative) or HR+ breast cancer\n\n  * HER2 testing should be performed on the invasive component using a validated immunohistochemistry (IHC) or in situ hybridization (ISH) assay\n  * IHC staining is defined as:\n\n    * IHC 3+ if there is complete and intense circumferential membrane staining within \\> 10 percent of tumor cells. All IHC 3+ tumors are considered HER2 positive\n    * IHC 2+ if there is incomplete and\u002For weak\u002Fmoderate, circumferential membrane staining within \\> 10 percent of tumor cells. All IHC 2+ tumors are reported as HER2 equivocal\n    * IHC 1+ if there is faint or barely perceptible, incomplete membrane staining within \\> 10 percent of tumor cells. All IHC 1+ tumors are reported as HER2 negative\n    * IHC 0 if (1) no staining is observed, or (2) there is faint or barely perceptible, incomplete membrane staining within \\\u003C 10 percent of tumor cells. All IHC 0 tumors are reported as HER2 negative\n    * Equivocal HER2 testing should trigger reflex HER2 testing using ISH on the same specimen or a new test (using a different specimen with either IHC or ISH)\n  * Results from ISH are defined as the ratio of gene amplification of HER2 and the chromosome 17 enumeration probe (CEP17). Results are reported as:\n\n    * ISH positive if the HER2\u002FCEP17 ratio is \\>= 2.0, and the HER2 copy number signals\u002Fcell is \\>= 4\n    * Definitive diagnosis will be rendered pending further workup in the following instances:\n\n      * If the HER2\u002FCEP17 ratio is \\>= 2.0 and an average HER2 copy number is \\\u003C 4.0 signals\u002Fcell - negative if confirmed on retesting\n      * If the HER2\u002FCEP17 ratio is \\\u003C 2.0 and the average HER2 copy number is \\>= 6.0 signals\u002Fcell positive - if confirmed on retesting\n      * If the HER2\u002FCEP17 ratio is \\\u003C 2.0 and an average HER2 copy number is between \\>= 4.0 and \\\u003C 6.0 signals\u002Fcell negative - if confirmed on retesting\n    * ISH negative if the HER2\u002FCEP17 ratio is \\\u003C 2.0 and average HER2 copy number is \\\u003C 4.0 signals\u002Fcell\n* Measurable brain disease as per RANO-BM criteria modified to include the cut off point of 0.5 cm or higher. Have at least one untreated (includes irradiation) brain metastasis approved by a research team that meets the following size requirements:\n\n  * \\>= 0.5 cm AND twice the magnetic resonance imaging (MRI) slice thickness; and\n  * \\\u003C 3.0 cm, that is asymptomatic and does not require local therapy at the time of enrollment (i.e. target lesion\\[s\\])\n  * Of note, lesions \\>= 0.5 cm and \\\u003C 3 cm may be determined ineligible by the research team because of location or symptoms. An untreated brain metastasis is defined as a lesion not present at the time of whole brain radiation therapy or not included in a stereotactic radiotherapy field (or within 0.5 cm of a treated lesion), or any lesion that is new or unequivocally progressing since prior radiation therapy or prior surgery.\n* Any brain metastasis \\>= 3.0 cm or causing symptoms must have previously been treated with local therapy (i.e. radiation or surgical resection, as clinically appropriate) prior to study enrollment. Any lesion present at the time of whole brain radiation therapy (WBRT) or included in the stereotactic radiotherapy field (or within 5 mm of the treated lesion) will NOT be considered evaluable unless it is new or documented to have progressed since treatment\n* Stereotactic radiosurgery (SRS) and\u002For prior radiotherapy is permitted \\>=2 weeks prior to initial Dendritic Cell (DC) vaccine dose (leaving one or more lesions which are not radiated and will be used as target lesions) but a follow up brain MRI should be obtained prior to dendritic cell (DC) vaccine to determine stability of the lesions. An interval of at least 4 weeks after the end of whole brain radiation or for any surgical resection of brain lesions is permitted ; an interval of at least 4 weeks or 5 half-lives (whichever is sorter) after the last cytotoxic, targeted, immunotherapeutic or investigational agent is permitted (prior to the start of DC vaccine)\n\n  * Previous whole brain radiation is allowed if patient has been diagnosed with recurrent, progressive brain metastasis. Previously irradiated lesions would be considered non-target lesions\n  * Previously resected lesions or those treated with SRS would be considered nontarget lesions. There is no limitation on prior local therapies to other lesions.\n* If subject received major surgery, they must have recovered adequately from the toxicity and\u002For complications from the intervention prior to starting therapy\n* Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1\n* Toxicity that has not recovered to \\\u003C=Grade 1 is allowed if it meets the inclusion requirments for lab parameters (Participants with \\\u003C= Grade 2 neuropathy may be eligible)\n* Patients must have adequate organ and marrow function as defined below (specimens must be collected within 10 days prior to the start of study treatment):\n* Hemoglobin \\>= 9 g\u002FdL or \\>= 5.6 mmol\u002FL\n* Leukocytes: \\>= 3 x 10\\^9\u002FL\n* Absolute neutrophil count: \\>= 1.5 x 10\\^9\u002FL\n* Platelets: \\>= 100 x 10\\^9\u002FL\n* Total bilirubin: =\\\u003C 1.5 x upper limit of normal (ULN) OR direct bilirubin =\\\u003C ULN for participants with total bilirubin levels \\> 1.5 x ULN\n* Aspartate aminotransferase (AST) (serum glutamic-oxaloacetic transaminase \\[SGOT\\])\u002Falanine aminotransferase (ALT) (serum glutamate pyruvate transaminase \\[SGPT\\]): =\\\u003C 2.5 x institutional upper limit of normal (=\\\u003C 5 x ULN for participants with liver metastases)\n* Creatinine OR Measured or calculated creatinine clearance (Glomerular Filtration Rate (GFR) can also be used in place of creatinine or CrCl): ≤1.5 × ULN OR ≥30 mL\u002Fmin for participant with creatinine levels \\>1.5 × institutional ULN\n* International normalized ratio (INR) OR prothrombin time (PT) activated partial thromboplastin time (APTT) =\\\u003C 1.5 x ULN unless participant is receiving anticoagulant therapy as long as PT or aPTT is within therapeutic range of intended use of anticoagulants\n* No evidence of leptomeningeal disease\n* If patient is on steroids, they must be on a steroid dose less than or = to an equivalent prednisone dose of 10 mg daily\n* Life expectancy of \\> 3 months\n* Prior checkpoint inhibitors permitted 3 weeks prior to enrollment\n* If the disease has progressed on current treatment in the CNS, prior to consent, patients may continue Her 2 directed antibody treatment (trastuzumab and pertuzumab); aromatase inhibitor or tamoxifen while on the study; patients with triple negative breast cancer may continue capecitabine, eribulin or paclitaxel while on study per PI discretion\n* Patients with systemic disease will be managed as detailed in Section 10.1 - Patients who develop systemic disease progression on the protocol will be managed as detailed in Section 10.4.2\n\nExclusion Criteria:\n\n* Any condition which might confound the results of the study, interfere with the subject's participation for full participation (for the full duration of the study) or in the Investigator's opinion deems the participant an unsuitable candidate for the study\n* Symptomatic brain metastases. Any neurologic symptoms present must have resolved with local therapy by the time of administration of study drugs\n* May not be receiving any other investigational agents and may not have participated in a study of an investigational agent or using an investigational device within 4 weeks of the first dose of DC vaccine treatment\n* Has had prior chemotherapy or targeted small molecule therapy (except treatment mentioned in inclusion criteria 17) within 4 weeks or 5 half-lives (whichever is sooner) prior to start of treatment (first DC vaccine) or who has not recovered (i.e., =\\\u003C grade 1 or at baseline) from adverse events due to a previously administered agent. Previous radiation to extracranial sites may be completed at any time prior to initiation of study drugs (first DC vaccine) with a 2-week washout is required.\n* Rapidly progressing systemic disease which might interfere with completion of all the vaccine doses\n* Active autoimmune disease that has required systemic treatment in the past 2 years (i.e. with use of disease modifying agents, corticosteroids or immunosuppressive drugs). Replacement therapy (e.g., thyroxine, insulin, or physiologic corticosteroid replacement therapy for adrenal or pituitary insufficiency, etc.) is not considered a form of systemic treatment and is allowed\n* History of allogenic tissue\u002Fsolid organ transplantation\n* Has an active infection requiring systemic therapy which in the investigator's opinion will increase risk to the patient\n* Has known active hepatitis B or hepatitis C infection (Testing is not mandatory)\n* Has known immunosuppressive disease (e.g. human immunodeficiency virus \\[HIV\\], acquired immunodeficiency syndrome \\[AIDS\\] or other immune depressing disease). Testing is not mandatory\n* Has received a blood transfusion in the two weeks prior to leukapheresis\n* Pregnant or actively nursing (females who agree to stop nursing would be eligible) participants\n* Unwilling or unable to follow protocol requirements\n* Brain lesion size with significant midline shift or obstructive hydrocephalus\n* The use of corticosteroids to control cerebral edema or treat neurologic symptoms will not be allowed unless at a low dose, not to exceed 10 mg of prednisone (or equivalent) per day\n* History of stroke or transient ischemic attack within 6 months prior to study enrollment\n* History of (non-infectious) pneumonitis \u002Finterstitial lung disease that required steroids, or has current pneumonitis\u002F interstitial lung disease\n* Presence of leptomeningeal disease\n* Any contraindication to MRI (i.e., patients with pacemakers or other metal implanted medical devices). An MRI safety questionnaire is required prior to MR imaging\n* Has received prior radiotherapy within 2 weeks of start of study treatment with dendritic cell (DC) vaccine and\u002For has received SRS \\\u003C2. weeks prior to the administration of the first DC vaccine dose. Participants must have recovered from all radiation-related toxicities, not require corticosteroids, and not have had radiation pneumonitis. A 1-week washout is permitted for palliative radiation (=\\\u003C 2 weeks of radiotherapy) to non-CNS disease\n* Has received a live vaccine or live-attenuated vaccine within 30 days prior to the first dose of study drug. Seasonal influenza vaccines for injection are allowed; however, intranasal influenza vaccines (e.g., FluMist) are live attenuated vaccines and are not allowed. Administration of killed vaccines is allowed.\n* Has a diagnosis of immunodeficiency or is receiving chronic systemic steroid therapy (in dosing exceeding 10 mg daily of prednisone equivalent) or any other form of immunosuppressive therapy within 7 days prior to the first dose of study drug (DC vaccine)\n* Has a known additional malignancy that is progressing or has required active treatment within the past 3 years. Note: Participants with basal cell carcinoma of the skin, squamous cell carcinoma of the skin, or carcinoma in situ (e.g. breast carcinoma, cervical cancer in situ) that have undergone potentially curative therapy are not excluded\n* A WOCBP who has a positive urine or blood pregnancy test at screening and within 72 hrs prior to leukapheresis\n\n  \\*Note: in the event that 72 hrs have elapsed between the initial screening pregnancy test and leukapheresis, another pregnancy test (urine or serum) must be performed and must be negative in order for subject to undergo leukapheresis\n* Known active carcinomatous meningitis\n* Known psychiatric or substance abuse disorders that would interfere with cooperation with the requirements of the trial.","FEMALE",{"count":218,"type":20},23,[128],"This phase IIa trial studies how well dendritic cell vaccines against Her2\u002FHer3 and pembrolizumab work for the treatment of triple negative breast cancer or HER2+ breast cancer or HER+ Breast cancer that has spread to the brain (brain metastasis). Dendritic cell vaccines work by boosting the immune system (a system in the body that protect against infection) to recognize and destroy the cancer cells. . Pembrolizumab is an \"immune checkpoint inhibitor\" which is designed to either \"unleash\" or \"enhance\" the cancer immune responses that already exist by either blocking inhibitory molecules\" or by activating stimulatory molecules. Giving dendritic cell vaccines and pembrolizumab may shrink the cancer.",[56,27,222,223],"Metastatic Triple-Negative Breast Carcinoma","Prognostic Stage IV Breast Cancer AJCC v8","2026-05-07",{"date":226,"type":34},"2026-05-11",{"date":228,"type":34},"2022-12-19",{"date":230,"type":20},"2027-12-15",{"name":232,"class":41},"Roswell Park Cancer Institute",3,{"id":235,"slug":236,"hasResults":11,"nctId":237,"briefTitle":238,"officialTitle":239,"acronym":4,"eligibilityCriteria":240,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":241,"targetDuration":4,"studyType":21,"phases":242,"briefSummary":243,"conditions":244,"keywords":4,"overallStatus":30,"whyStopped":4,"lastUpdateSubmitDate":245,"lastUpdatePostDateStruct":246,"startDateStruct":248,"completionDateStruct":250,"leadSponsor":252,"locationsCount":253},"100456363","phase-2-srs-compared-with-fsrs-for-treatment-of-intact-metastatic-brain-disease-fractionate-trial-100456363","NCT05222620","SRS Compared With FSRS for Treatment of Intact Metastatic Brain Disease, FRACTIONATE Trial","Phase IIR Trial of Single Fraction Stereotactic Radiosurgery (SRS) Compared With Fractionated SRS (FSRS) for Intact Metastatic Brain Disease (FRACTIONATE)","Inclusion Criteria:\n\n* Age \\>= 18 years old\n* Presence of presumed brain metastases from an extra-cerebral tumor site (e.g. lung, breast, prostate, etc.)\n\n  * Note: Dural based metastases (e.g. commonly seen in breast cancer) are eligible\n* Size of brain metastases\n\n  * At least one intact metastasis (not previously treated with radiosurgery) must measure \\>= 2.0 cm and =\\\u003C 4.0 cm in maximal extent on the contrasted pre-treatment magnetic resonance imaging (MRI) brain scan obtained =\\\u003C 28 days prior to registration\n  * If the largest lesion measures \\>= 2.0 to =\\\u003C 4.0 cm in maximal extent the patient will be randomized\n* Able to undergo contrast enhanced MRI brain\n* Negative urine or serum pregnancy test completed =\\\u003C 7 days prior to registration, for women of childbearing potential only\n* Patient is willing and able to provide written informed consent or have a legally Authorized Representative (LAR) who is responsible for the care and well-being of the potential study participant provide consent.\n* Karnofsky performance status (KPS) \\>= 50\n* Eastern Cooperative Oncology Group (ECOG) performance score of (PS) \\>= 2\n* Past radiosurgery or resection is allowed as long as no definitive evidence of progression in these locations\n\n  * Note: Repeat radiosurgery to the same location\u002Flesion is not allowed on this protocol\n\nExclusion Criteria:\n\n* Any patient who has received previous whole brain radiation\n* Any brain metastasis that is located in the brainstem measuring \\>= 2.0 cm in maximal extent\n* Any patient with definitive evidence of leptomeningeal metastasis (LMD)\n\n  * NOTE: For the purposes of exclusion, LMD is a clinical diagnosis, defined as positive cerebrospinal fluid (CSF) cytology and\u002For unequivocal radiologic or clinical evidence of leptomeningeal involvement. Patients with leptomeningeal symptoms in the setting of leptomeningeal enhancement by imaging (MRI) would be considered to have LMD even in the absence of positive CSF cytology, unless a parenchymal lesion can adequately explain the neurologic symptoms and\u002For signs. In contrast, an asymptomatic or minimally symptomatic patient with mild or nonspecific leptomeningeal enhancement (MRI) would not be considered to have LMD. In that patient, CSF sampling is not required to formally exclude LMD, but can be performed at the investigator's discretion based on level of clinical suspicion\n* Any patient with an intact brain metastasis measuring \\> 4.0 cm",{"count":172,"type":20},[128],"This phase II trial compares the effect of single fraction stereotactic radiosurgery to fractionated stereotactic radiosurgery for the treatment of patients with cancer that has spread to the brain (metastatic brain disease). Stereotactic radiosurgery (SRS) is a form of radiation therapy that focuses high-power energy on a small area of the body. This trial is being done to determine if single (one) fraction stereotactic radiosurgery is better than fractionated stereotactic radiosurgery or vice versa in controlling tumor and side effects in patients with tumors that have spread to the brain.",[27,81],"2026-04-09",{"date":247,"type":34},"2026-04-13",{"date":249,"type":34},"2022-03-14",{"date":251,"type":20},"2028-02-15",{"name":115,"class":41},7,{"id":255,"slug":256,"hasResults":11,"nctId":257,"briefTitle":258,"officialTitle":258,"acronym":4,"eligibilityCriteria":259,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":260,"targetDuration":4,"studyType":261,"phases":4,"briefSummary":262,"conditions":263,"keywords":4,"overallStatus":30,"whyStopped":4,"lastUpdateSubmitDate":267,"lastUpdatePostDateStruct":268,"startDateStruct":270,"completionDateStruct":272,"leadSponsor":274,"locationsCount":66},"100438340","patient-perceptions-around-quality-of-care-through-telemedicine-in-neuro-oncology-100438340","NCT04988009","Patient Perceptions Around Quality of Care Through Telemedicine in Neuro-Oncology","Inclusion Criteria:\n\n* Patients with a CNS tumors: this includes patients with primary brain tumors, brain metastases, and leptomeningeal disease\n* Established patients with a follow up encounter with Neuro-Oncology at the Brain and Spine Center at the University of Texas MD Anderson Cancer Center; this encounter can be\n\n  * An in-person visit\n  * A telemedicine appointment\n\nExclusion Criteria:\n\n* Encounter occurred with the assistance of official language translation support\n* Patients with telephone encounters (without interactive video)\n* New patient or consult visits\n* Neither patient nor caregiver present during the visit are available or able to answer survey questions",{"count":19,"type":20},"OBSERVATIONAL","This study evaluates patient perceptions around quality of care through telemedicine in neuro-oncology. Studying questionnaires related to perceptions quality of care through telemedicine in patients with brain cancer may help doctors to improve the delivery of care through this modality.",[264,265,27,266],"Central Nervous System Neoplasm","Leptomeningeal Neoplasm","Primary Brain Neoplasm","2026-03-03",{"date":269,"type":34},"2026-03-05",{"date":271,"type":34},"2020-08-20",{"date":273,"type":20},"2026-12-31",{"name":208,"class":41},{"id":276,"slug":277,"hasResults":11,"nctId":278,"briefTitle":279,"officialTitle":280,"acronym":4,"eligibilityCriteria":281,"healthyVolunteers":11,"sex":16,"minAge":282,"maxAge":4,"enrollmentInfo":283,"targetDuration":4,"studyType":21,"phases":285,"briefSummary":286,"conditions":287,"keywords":4,"overallStatus":30,"whyStopped":4,"lastUpdateSubmitDate":289,"lastUpdatePostDateStruct":290,"startDateStruct":292,"completionDateStruct":294,"leadSponsor":296,"locationsCount":66},"100306502","phase-2-gadolinium-and-ferumoxytol-mri-in-diagnosing-patients-with-abnormalities-in-the-central-nervous-system-100306502","NCT03270059","Gadolinium and Ferumoxytol MRI in Diagnosing Patients With Abnormalities in the Central Nervous System","The Feasibility of Steady State CBV Mapping Using Ferumoxytol Immediately After Gadolinium Enhanced MRI of the CNS","Inclusion Criteria:\n\n* Subjects must have one of the following:\n\n  * Neurological findings (i.e. headache, loss of consciousness, paresis, cranial neuropathy, seizures, etc.)\n  * Radiological abnormalities in the brain (neoplastic or non-neoplastic in nature)\n  * Neoplastic process elsewhere in the body that may affect the brain (i.e. possible metastasis, vascular compromise, treatment related changes, etc.)\n* Subjects must be able to undergo MRI imaging without anesthesia\n* Subjects must be at least 10 years of age\n* All subjects, or their legal guardians, must sign a written informed consent and Health Insurance Portability and Accountability Act (HIPAA) authorization in accordance with institutional guidelines\n* Sexually active women of child-bearing potential must agree to use adequate contraception (hormonal or barrier method of birth control; surgical intervention i.e. tubal ligation or vasectomy; post-menopausal \\\u003C 6 months; or abstinence) for at least two months after each cycle of the study; should a female become pregnant or suspect she is pregnant while participating in this study, she should inform her treating physician immediately\n\nExclusion Criteria:\n\n* Subjects with clinically significant signs of uncal herniation, such as acute pupillary enlargement, rapidly developing motor changes (over hours), or rapidly decreasing level of consciousness, are not eligible\n* Subjects with known allergic or hypersensitivity reactions to parenteral iron, parenteral dextran, parenteral iron-dextran, or parenteral iron-polysaccharide preparations (Ferumoxytol Investigator's Drug Brochure, 2009); subjects with significant drug or other allergies or autoimmune diseases may be enrolled at the investigator's discretion\n* Subjects who are pregnant or lactating or who suspect they might be pregnant\n* Subjects who have a contraindication for MRI: metal in their bodies (a cardiac pacemaker or other incompatible device), are severely agitated, or have an allergy to gadolinium containing contrast material\n* Subjects with known iron overload (genetic hemochromatosis); in subjects with a family history of hemochromatosis, hemochromatosis must be ruled out prior to study entry with normal values of the following blood tests: transferrin saturation (TS) test and serum ferritin (SF) test; all associated costs will be paid by the study\n* Subject who have received ferumoxytol within 3 weeks of study entry\n* Subjects with three or more drug allergies from separate drug classes","10 Years",{"count":284,"type":20},150,[128],"This phase II trial studies how well gadolinium and ferumoxytol magnetic resonance imaging (MRI) work in diagnosing patients with abnormalities in the central nervous system. Diagnostic procedures, such as gadolinium and ferumoxytol MRI, may help find and diagnose abnormalities in the central nervous system.",[264,288,27],"Cranial Nerve Disorder","2026-02-25",{"date":291,"type":34},"2026-02-27",{"date":293,"type":34},"2017-10-06",{"date":295,"type":20},"2028-12-15",{"name":297,"class":41},"OHSU Knight Cancer Institute",{"id":299,"slug":300,"hasResults":11,"nctId":301,"briefTitle":302,"officialTitle":303,"acronym":4,"eligibilityCriteria":304,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":305,"targetDuration":4,"studyType":21,"phases":307,"briefSummary":308,"conditions":309,"keywords":4,"overallStatus":30,"whyStopped":4,"lastUpdateSubmitDate":312,"lastUpdatePostDateStruct":313,"startDateStruct":315,"completionDateStruct":317,"leadSponsor":319,"locationsCount":66},"100366130","feasibility-of-intraoperative-microdialysis-during-neurosurgery-for-central-nervous-system-malignancies-100366130","NCT04047264","Feasibility of Intraoperative Microdialysis During Neurosurgery for Central Nervous System Malignancies","Intraoperative Microdialysis During Neurosurgery for Central Nervous System Malignancies","Inclusion Criteria:\n\n* Age \\>= 18 years\n* Diagnosis of the following, based on clinical and radiographic evidence:\n\n  * Any glioma\n  * Metastatic brain tumor of any primary origin\n  * Epileptic focus requiring surgical resection\n* Planned neurosurgical procedure for purposes of biopsy or resection of suspected or previously diagnosed brain tumor (primary or metastatic) or epileptic focus as part of routine clinical care\n* Willing to undergo neurosurgical resection or biopsy at Mayo Clinic (Rochester, Minnesota \\[MN\\])\n* Ability to understand and the willingness to sign a written informed consent document\n\nExclusion Criteria:\n\n* Vulnerable populations: pregnant women, prisoners or the mentally handicapped\n* Patients who are not appropriate candidates for surgery due to current or past medical history or uncontrolled concurrent illness",{"count":306,"type":20},100,[174],"This clinical trial evaluates the use of microdialysis catheters during surgery to collect biomarkers, and studies the feasibility of intraoperative microdialysis during neurosurgery for central nervous system malignancies. A biomarker is a measurable indicator of the severity or presence of disease state. Information collected in this study may help doctors to develop new strategies to better diagnose, monitor, and treat brain tumors.",[310,311,27],"Glioma","Glioblastoma","2026-02-10",{"date":314,"type":34},"2026-02-12",{"date":316,"type":34},"2020-01-01",{"date":318,"type":20},"2027-09-01",{"name":115,"class":41},{"id":321,"slug":322,"hasResults":11,"nctId":323,"briefTitle":324,"officialTitle":325,"acronym":4,"eligibilityCriteria":326,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":327,"targetDuration":4,"studyType":21,"phases":329,"briefSummary":330,"conditions":331,"keywords":4,"overallStatus":30,"whyStopped":4,"lastUpdateSubmitDate":334,"lastUpdatePostDateStruct":335,"startDateStruct":337,"completionDateStruct":339,"leadSponsor":341,"locationsCount":66},"100566052","phase-1-zr-89-crefmirlimab-berdoxam-and-immuno-positron-emission-tomography-for-the-imaging-of-patients-with-resectable-brain-tumors-100566052","NCT06650163","Zr-89 Crefmirlimab Berdoxam and Immuno-Positron Emission Tomography for the Imaging of Patients With Resectable Brain Tumors","Biologic Validation of Zr-89 Crefmirlimab Berdoxam CD8+ Minibody ImmunoPET in Human Brain Tumors","Inclusion Criteria:\n\n* Male or female \\>= 18 years of age\n* Documentation of a diagnosis of brain tumor including brain metastases, any grade of gliomas and meningiomas\n* The participant is scheduled for standard of care surgical tumor resection\n* The participant (or legally acceptable representative if applicable) provides written informed consent for the trial\n\nExclusion Criteria:\n\n* Male or female \\\u003C 18 years of age\n* Presence of a condition or abnormality that in the opinion of the Investigator would compromise the safety of the patient or the quality of the data\n* Not medically cleared for surgery\n* Individuals who cannot tolerate MRI scan or PET\u002FCT scan\n* Pregnant or breast-feeding women\n* Serum creatinine OR measured or calculated creatinine clearance (Glomerular filtration rate \\[GFR\\] can be use in place of creatinine or creatinine clearance \\[CrCl\\]) =\\\u003C 1.5 X institutional upper limit of normal (ULN) OR \\>= 60mL\u002Fmin for subjects with creatinine levels \\> 1.5 X institutional ULN\n\n  * Creatinine clearance should be calculated per institutional standard\n* Serum total bilirubin: =\\\u003C 1.5 X institutional ULN OR direct bilirubin =\\\u003C institutional ULN for subjects with total bilirubin levels \\> 1.5 institutional ULN\n* Aspartate aminotransferase (AST) (serum glutamic oxaloacetic transaminase \\[SGOT\\]) and alanine aminotransferase (ALT) (serum glutamic pyruvic transaminase \\[SGPT\\]) =\\\u003C 2.5 X institutional ULN OR =\\\u003C 5 X institutional ULN for subjects with Gilberts syndrome\n* Albumin \\>= 2.5 mg\u002FdL\n* Patients with splenic dysfunction or post splenectomy\n* Any abnormalities that would be a contraindication to gadolinium-based contrast agent",{"count":328,"type":20},20,[127],"This phase I trial studies how well zirconium (Zr)-89 crefmirlimab berdoxam and immuno-positron emission tomography (PET) identifies areas of immune cell activity in patients with brain tumors that can be removed by surgery (resectable). One important predictor of the immune response is the presence and change in CD8 positive (+) tumor infiltrating lymphocytes (TIL) cells. Identifying the presence and changes in CD8+ cells can be challenging, particularly for participants with central nervous system (CNS) tumors, and usually requires invasive procedures such as repeat tissue biopsies, which may not accurately represent the immune status of the entire tumor. Zr-89 crefmirlimab berdoxam is known as a radioimmunoconjugate which consists of a radiolabeled anti-CD8+ minibody whose uptake can be imaged with PET. Upon administration, Zr 89 crefmirlimab berdoxam specifically targets and binds to the CD8+ cells. This enables PET imaging and may detect CD8+ T-cell distribution and activity and may help determine the patient's response to cancer immunotherapeutic agents more accurately. Giving Zr-89 crefmirlimab berdoxam along with undergoing immuno-PET imaging may work better at identifying immune cell activity in patients with resectable brain tumors.",[310,332,333,27],"Malignant Brain Neoplasm","Meningioma","2026-02-03",{"date":336,"type":34},"2026-02-05",{"date":338,"type":34},"2024-12-05",{"date":340,"type":20},"2028-01-31",{"name":342,"class":41},"Jonsson Comprehensive Cancer Center",{"id":344,"slug":345,"hasResults":11,"nctId":346,"briefTitle":347,"officialTitle":348,"acronym":4,"eligibilityCriteria":349,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":350,"targetDuration":4,"studyType":21,"phases":352,"briefSummary":353,"conditions":354,"keywords":4,"overallStatus":30,"whyStopped":4,"lastUpdateSubmitDate":355,"lastUpdatePostDateStruct":356,"startDateStruct":358,"completionDateStruct":360,"leadSponsor":362,"locationsCount":66},"100619012","advanced-magnetic-resonance-imaging-for-the-identification-of-recurrent-brain-tumors-and-radiation-necrosis-100619012","NCT07339085","Advanced Magnetic Resonance Imaging for the Identification of Recurrent Brain Tumors and Radiation Necrosis","Advanced Dual-Nuclei MRI for Differentiation of Recurrent Brain Metastases and Radiation Necrosis","Inclusion Criteria:\n\n* Age \\> 18 years old\n* Diagnosed with metastatic brain tumor\n* AIM 1: Scheduled for surgical resection or tissue biopsy +\u002F- laser interstitial thermal therapy (LITT)\n* AIM 2: Scheduled for SRS treatment\n\nExclusion Criteria:\n\n* Patients with contraindications to MRI, severe renal impairment\n* Patients with evidence of disseminated leptomeningeal disease",{"count":351,"type":20},42,[174],"This clinical trial studies whether advanced magnetic resonance imaging (MRI) techniques, including diffusion-relaxation correlation spectrum imaging (DR-CSI) and sodium imaging, can be used to identify the difference between brain tumors that come back after a period of improvement (recurrent) and treatment-related tissue damage (radiation necrosis \\[RN\\]). Radiation therapy is often used in the treatment of brain tumors. Radiation treatment response can be difficult to assess and is usually done using conventional MRI, which uses radio waves and a powerful magnet linked to a computer to create detailed pictures of areas inside the body. Current imaging techniques have a limited ability to identify the difference between recurrent brain tumor and RN due to their similar appearance on conventional MRI and overlapping clinical presentation. This makes it hard for doctors to plan the best way to treat these tumors. DR-CSI is a new MRI technique with the potential to detect microscopic tissue components with different characteristics. Sodium imaging is an MRI technique that estimates the total sodium concentration in the obtained images. It may be able to identify the small structures within the tissue of brain tumors. Advanced MRI techniques like DR-CSI and sodium imaging may be effective in identifying the difference between recurrent brain tumors and RN.",[332,27],"2026-01-14",{"date":357,"type":34},"2026-01-15",{"date":359,"type":34},"2025-08-28",{"date":361,"type":20},"2030-07-30",{"name":342,"class":41},{"id":364,"slug":365,"hasResults":11,"nctId":366,"briefTitle":367,"officialTitle":368,"acronym":4,"eligibilityCriteria":369,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":370,"targetDuration":4,"studyType":21,"phases":372,"briefSummary":373,"conditions":374,"keywords":4,"overallStatus":30,"whyStopped":4,"lastUpdateSubmitDate":379,"lastUpdatePostDateStruct":380,"startDateStruct":382,"completionDateStruct":384,"leadSponsor":386,"locationsCount":389},"100317923","phase-3-s1501-dual-observational-and-randomized-cohort-study-of-patients-with-metastatic-her-2-breast-cancer-at-risk-of-cardiac-toxicity-100317923","NCT03418961","S1501 Dual Observational and Randomized Cohort Study of Patients With Metastatic HER-2+ Breast Cancer at Risk of Cardiac Toxicity","Prospective Observational Cohort Study of Patients With Metastatic HER-2+ Breast Cancer at Risk of Cardiac Toxicity","Inclusion Criteria:\n\n* STEP 1 REGISTRATION\n\nPatients must:\n\n1. Have metastatic breast cancer, AND\n2. Be initiating within 11 calendar days of Step 1 Registration OR be continuing trastuzumab-based HER-2 targeted therapy without concurrent anthracyclines, AND\n3. Be receiving the trastuzumab-based HER-2 targeted therapy for metastatic disease in first, second, third-, or fourth-line setting. Patients may have brain metastasis. There is no limit for number of doses of HER-2 targeted therapy prior to registration.\n\nExamples of eligible HER-2 targeted therapy:\n\n* Trastuzumab or a trastuzumab biosimilar\n* Trastuzumab + chemotherapy or hormonal therapy\n* Trastuzumab + other HER-2 targeted agent with or without chemotherapy (such as pertuzumab, lapatinib, and tucatinib)\n* Ado-trastuzumab (Kadcyla®)\n* Fam-trastuzumab deruxtecan (Enhertu) NOTE: Patients on lapatinib without trastuzumab are not eligible. Planned treatment with concurrent HER-2 targeted therapy and anthracyclines is not permitted.\n\n  * Patients must be at increased risk for cardiotoxicity defined by at least one of the following:\n\n    1. Previous anthracycline exposure OR\n    2. 1 or more of the following risk factors for heart disease:\n\n       * LVEF 50-54% by local ECHO read\\*\n       * Age ≥ 65\n       * BMI ≥ 30 kg\u002Fm2\n       * Current or prior anti-hypertensive therapy\n       * Diagnosis of coronary artery disease (CAD)\n       * Diagnosis of diabetes mellitus\n       * Diagnosis of atrial fibrillation\u002Fflutter Note: ECHO can be performed at any time prior to registration with the most recent being sent.\n  * Patients must not have taken within 21 days prior to Step 1 Registration, be currently taking at the time of Step 1 Registration or planning to take once registered to Step 1 a beta blocker, ARB, or ACE inhibitor, in order to be randomized (Arms 1 and 2).\n\nPatients enrolling in the observational cohort (Arm 3) must be currently taking a beta blocker, ARB, or ACE inhibitor at the time of Step 1 Registration.\n\n* Patients must have a Zubrod Performance status of 0-2\n* Patients must have a complete physical examination and medical history within 28 days prior to registration\n* Patients must have LVEF \\>= 50% echocardiogram (2D or 3D) within 28 days prior to registration. The echocardiogram must be obtained from a S1501 validated ECHO laboratory (lab) and submitted for central review by the S1501 ECHO core lab.\n\nIf a 3D echocardiogram is performed at baseline, sites must ensure that standard 2D images, including 40chamber and 2-chamber views, are also obtained and submitted at subsequent timepoints.\n\nAll follow-up echocardiograms (every 12 weeks) must be performed using 2D imaging to allow for standardized assessments. Follow-up scans must be completed at a site that can provide 2D images per protocol requirements. The echocardiograms cannot be submitted for central read until after Step 1 registration is complete.\n\n* Patients must have adequate hepatic function as evidenced by all of the following within 28 days prior to registration:\n\n  * Serum bilirubin \\\u003C 3.0 x institutional upper limit of normal (IULN)\n  * Serum glutamic oxaloacetic transaminase (SGOT)\u002Faspartate aminotransferase (AST) and serum glutamic pyruvic transaminase (SGPT)\u002Falanine aminotransferase (ALT) \\\u003C 5.0 x IULN\n* Patients must not be dialysis dependent\n* No other prior malignancy is allowed except for the following: adequately treated basal cell or squamous cell skin cancer, in situ cervical cancer, prostate cancer on active surveillance, adequately treated stage I or II cancer from which the patient is currently in complete remission, or any other cancer from which the patient has been disease free for five years\n* Patients must not be pregnant or nursing due to potential fetal or nursing infant harm; women\u002Fmen of reproductive potential must have agreed to use an effective contraceptive method, a woman is considered to be of \"reproductive potential\" if she has had menses at any time in the preceding 12 consecutive months; in addition to routine contraceptive methods, \"effective contraception\" also includes heterosexual celibacy and surgery intended to prevent pregnancy (or with a side-effect of pregnancy prevention) defined as a hysterectomy, bilateral oophorectomy or bilateral tubal ligation; however, if at any point a previously celibate patient chooses to become heterosexually active during the time period for use of contraceptive measures outlined in the protocol, he\u002Fshe is responsible for beginning contraceptive measures\n* Patients must be willing to submit blood specimens\n* Sites must seek additional patient consent for the future use of specimens\n* Patients must be informed of the investigational nature of this study and must sign and give written informed consent in accordance with institutional and federal guidelines\n* For participants with impaired decision-making capabilities, legally authorized representatives may sign and give informed consent on behalf of study participants in accordance with applicable federal, local, and CIRB regulations.\n* As a part of the OPEN registration process the treating institution's identity is provided in order to ensure that the current (within 365 days) date of institutional review board approval for this study has been entered in the system\n* STEP 2 REGISTRATION (Randomization)\n* Patients must not be registered to step 2 until confirming via RAVE EDC that the patient's LVEF by echocardiogram was \\>= 50% by central review. Patients must be registered within 21 calendar days of submission of the ECHO study\u002F\n* Site must verify that there is no known change in the step 1 eligibility since initial registration",{"count":371,"type":20},491,[23],"This trial has two cohorts of patients with human epidermal growth factor receptor (HER)-2-positive breast cancer that has spread to other places in the body. All patients must be receiving trastuzumab-based treatment. Both cohorts are being observed for cardiac toxicity. The largest cohort (currently open to accrual) is observational, and contains patients who are taking a beta blocker, ACE inhibitor, or ARB as well as their trastuzumab-based treatment. The goal is to understand how common cardiac problems are in this group of patients at high risk. The smaller cohort (currently closed to accrual) is randomized. Patients in this second cohort are randomized to either carvedilol or no treatment, with the goal of seeing whether carvedilol (used to treat heart failure and high blood pressure) may prevent the heart from side effects of chemotherapy.",[375,376,27,377,378],"Cardiotoxicity","HER2\u002FNeu Positive","Recurrent Breast Carcinoma","Stage IV Breast Cancer AJCC v6 and v7","2025-10-03",{"date":381,"type":34},"2025-10-08",{"date":383,"type":34},"2017-11-01",{"date":385,"type":20},"2027-09-15",{"name":387,"class":388},"SWOG Cancer Research Network","NETWORK",590,{"id":391,"slug":392,"hasResults":11,"nctId":393,"briefTitle":394,"officialTitle":395,"acronym":4,"eligibilityCriteria":396,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":397,"targetDuration":4,"studyType":21,"phases":398,"briefSummary":400,"conditions":401,"keywords":4,"overallStatus":30,"whyStopped":4,"lastUpdateSubmitDate":402,"lastUpdatePostDateStruct":403,"startDateStruct":405,"completionDateStruct":407,"leadSponsor":409,"locationsCount":66},"100541348","early-phase-1-arginine-and-whole-brain-radiation-therapy-for-the-treatment-of-patients-with-brain-metastases-100541348","NCT06328686","Arginine and Whole Brain Radiation Therapy for the Treatment of Patients With Brain Metastases","Arginine With Whole Brain Radiation Therapy for the Treatment of Brain Metastases","Inclusion Criteria:\n\n* Diagnosis of brain metastases from any primary cancer\n* Planned to undergo whole-brain radiation therapy (Hippocampal avoidant is ok)\n* No systemic anti-neoplastic agent concurrent with WBRT (memantine is ok)\n* Not inpatient at the time of treatment start\n* Age 18 or older\n* Able to consent for self\n\nExclusion Criteria:\n\n* Patient unwilling\u002Funable to receive daily arginine treatment (IV or oral) for the 10 days of WBRT\n* Systemic therapy continuing during WBRT\n* Creatinine \\> 1.5 x the upper limit of normal\n* Alanine aminotransferase (ALT) \\> 6x the upper limit of normal\n* Patient planned to be treated as an inpatient\n* Age \\\u003C 18 years\n* Adult not able to consent for self\n* Pregnant\n* Prisoners\n* Cognitively impaired\u002Fimpaired decision-making capacity",{"count":51,"type":20},[399],"EARLY_PHASE1","This early phase I trial evaluates different administration techniques (oral or intravenous) for arginine and tests the safety of giving arginine with whole brain radiation therapy in patients who have cancer that has spread from where it first started (primary site) to the brain (brain metastases). Arginine is an essential amino acid. Amino acids are the molecules that join together to form proteins in the body. Arginine supplementation has been shown to improve how brain metastases respond to radiation therapy. The optimal dosing of arginine for this purpose has not been determined. This study measures the level of arginine in the blood with oral and intravenous dosing at specific time intervals before and after drug administration to determine the best dosing strategy.",[27,81],"2025-09-16",{"date":404,"type":34},"2025-09-17",{"date":406,"type":34},"2024-09-05",{"date":408,"type":20},"2027-12-31",{"name":410,"class":41},"Emory University",{"id":412,"slug":413,"hasResults":11,"nctId":414,"briefTitle":415,"officialTitle":416,"acronym":4,"eligibilityCriteria":417,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":418,"targetDuration":4,"studyType":21,"phases":420,"briefSummary":421,"conditions":422,"keywords":4,"overallStatus":30,"whyStopped":4,"lastUpdateSubmitDate":426,"lastUpdatePostDateStruct":427,"startDateStruct":429,"completionDateStruct":431,"leadSponsor":433,"locationsCount":434},"100401727","phase-2-a-study-to-compare-the-administration-of-encorafenib--binimetinib--nivolumab-versus-ipilimumab--nivolumab-in-braf-v600-mutant-melanoma-with-brain-metastases-100401727","NCT04511013","A Study to Compare the Administration of Encorafenib + Binimetinib + Nivolumab Versus Ipilimumab + Nivolumab in BRAF-V600 Mutant Melanoma With Brain Metastases","A Randomized Phase 2 Trial of Encorafenib + Binimetinib + Nivolumab vs Ipilimumab + Nivolumab in BRAF-V600 Mutant Melanoma With Brain Metastases","Inclusion Criteria:\n\n* Participants must have histologically and pathologically confirmed melanoma that has metastasized to the brain\n* Any primary (cutaneous, acral\u002Fmucosal, etc) or unknown origin are permitted, except that participants with uveal primary are not eligible\n* Participants must have BRAF-V600 mutant melanoma documented by a Clinical Laboratory Improvement Act (CLIA)-certified laboratory\n* All participants must have an magnetic resonance imaging (MRI) of the brain within 28 days prior to registration and must have central nervous system metastases with at least one measurable brain metastasis \\>= 0.5 cm in size (per modified RECIST 1.1) that has not been irradiated, or progressed (in the opinion of the treating physician) after prior radiation therapy. Participating sites MUST use MRI slice thickness of =\\\u003C 1.5 mm and are recommended to adhere to the 'minimum' Brain Tumor Imaging Protocol for Clinical Trials in Brain Metastases (BTIP-BM) compliant MRI acquisition protocol. Computed tomography (CT) of the head cannot substitute for brain MRI. (NOTE: All central nervous system \\[CNS\\] disease must be documented on BOTH the Brain Metastases Baseline Tumor Assessment Form, using modified RECIST, and the Baseline Tumor Assessment Form \\[RECIST 1.1\\] using RECIST 1.1.)\n* Participants may have measurable or non-measurable extracranial disease. All measurable disease must be assessed within 28 days prior to randomization; all non-measurable disease must be assessed within 42 days prior to randomization. Please note, while any extracranial disease will also be assessed and followed, participants are NOT required to have extracranial disease for randomization. NOTE: All disease must be assessed and documented on the Baseline Tumor Assessment Form (RECIST 1.1). CNS disease must be documented on BOTH the Brain Metastases Baseline Tumor Assessment Form, using modified RECIST, and the Baseline Tumor Assessment Form (RECIST 1.1) using RECIST 1.1\n* Participants may have leptomeningeal disease\n* Participants may be receiving corticosteroids for brain metastases at a dose of up to 8 mg of dexamethasone per day. The dose must not have exceeded 8 mg per day for at least 7 days prior to randomization\n* Participants must have Zubrod performance status =\\\u003C 2\n* Participants must have complete history and physical examination within 28 days prior to randomization\n* Participants must be able to swallow and retain pills\n* Hemoglobin \\>= 8.0 g\u002FdL (within 28 days prior to randomization)\n* Absolute neutrophil count \\>= 1,500\u002FmcL (within 28 days prior to randomization)\n* Platelets \\>= 75,000\u002FmcL (within 28 days prior to randomization)\n* Total bilirubin =\\\u003C 1.5 institutional upper limit of normal (ULN) (within 28 days prior to randomization)\n* Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) =\\\u003C 2.5 x institutional ULN (in participants with liver metastases =\\\u003C 5 x ULN) (within 28 days prior to randomization)\n* Creatinine =\\\u003C 2.0 institutional ULN (within 28 days prior to randomization)\n* Participants with known history or current symptoms of cardiac disease, or history of treatment with cardiotoxic agents, must have a clinical risk assessment of cardiac function using the New York Heart Association Functional Classification. To be eligible for this trial, participants must be class 2B or better\n* Participants with a prior or concurrent malignancy whose natural history or treatment (in the opinion of the treating physician) does not have the potential to interfere with the safety or efficacy assessment of the investigational regimen are eligible for this trial\n* Participants with known human immunodeficiency virus (HIV)-infection are eligible providing they are on effective anti-retroviral therapy and have undetectable viral load at their most recent viral load test and within 90 days prior to randomization\n* Participants with a known history of hepatitis C virus (HCV) infection must have been treated and cured. Participants with HCV infection who are currently on treatment must have an undetectable HCV viral load prior to randomization\n* Participants must agree to participate in image banking. Images must be submitted via the Triad System\n* Participants must be offered the opportunity to participate in specimen and blood collections\n* Participants must be informed of the investigational nature of this study and must sign and give informed consent in accordance with institutional and federal guidelines\n* As a part of the OPEN registration process the treating institution's identity is provided in order to ensure that the current (within 365 days) date of institutional review board approval for this study has been entered in the system\n\nExclusion Criteria:\n\n* Participants must not have received prior systemic therapy for metastatic disease. Prior systemic therapy received only in the neoadjuvant and\u002For adjuvant setting (e.g., BRAF\u002FMEK inhibitor therapy, anti-PD-1 therapy or anti-CTLA4 therapy, alfa-interferon, etc.) is permitted. If patients received prior neoadjuvant\u002Fadjuvant therapy, they must have had eventual disease relapse prior to randomization\n* Participants must not have had prior radiation therapy within 7 days prior to randomization\n* Participants must not be planning to require any additional form of systemic anti-tumor therapy for melanoma while on protocol treatment\n* Participants must not be planning to use hormonal contraceptives\n* Participants must not have a serious active infection requiring systemic therapy at time of randomization in the opinion of the treating physician\n* Participants must not have active autoimmune disease that has required treatment in the past 6 months with use of biologic disease modifying agents (.e.g. infliximab, adalimumab). Patients on non-biologic disease modifying agents (e.g. methotrexate) or patients on corticosteroids =\\\u003C 10 mg prednisone daily or equivalent (to treat auto-immune disease), or on replacement therapy (e.g., thyroxine, insulin) are eligible if deemed in the best interest of the patient by treating physician\n* Participants must not have had grade 3 or 4 immune-related adverse events on ipilimumab or nivolumab that required more than 12 weeks of immune suppression with corticosteroids\n* Participants must not have had adverse events related to encorafenib and\u002For binimetinib specifically, that required discontinuation of one or both drugs. (Please note this does not apply to other BRAF\u002FMEK inhibitor drugs.)\n* Participants must not be pregnant or nursing. Women\u002Fmen of reproductive potential must have agreed to use an effective method of contraception. (NOTE: Patients must agree to not use hormonal contraceptives, as encorafenib can result in decreased concentration and loss of efficacy.) A woman is considered to be of \"reproductive potential\" if she has had menses at any time in the preceding 12 consecutive months. In addition to routine contraceptive methods, \"effective contraception\" also includes heterosexual celibacy and surgery intended to prevent pregnancy (or with a side-effect of pregnancy prevention) defined as a hysterectomy, bilateral oophorectomy or bilateral tubal ligation. However, if at any point a previously celibate participant chooses to become heterosexually active during the time period for use of contraceptive measures outlined in the protocol, he\u002Fshe is responsible for beginning contraceptive measures",{"count":419,"type":20},112,[128],"This phase II trial compares the effect of encorafenib, binimetinib, and nivolumab versus ipilimumab and nivolumab in treating patients with BRAF- V600 mutant melanoma that has spread to the brain (brain metastases). Encorafenib and binimetinib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Ipilimumab and nivolumab are monoclonal antibodies that may interfere with the ability of tumor cells to grow and spread. This trial aims to find out which approach is more effective in shrinking and controlling brain metastases from melanoma.",[423,131,424,27,82,425,132],"Acral Lentiginous Melanoma","Metastatic Cutaneous Melanoma","Metastatic Mucosal Melanoma","2025-09-04",{"date":428,"type":34},"2025-09-11",{"date":430,"type":34},"2021-01-06",{"date":432,"type":20},"2027-06-30",{"name":387,"class":388},331,{"id":436,"slug":437,"hasResults":11,"nctId":438,"briefTitle":439,"officialTitle":440,"acronym":4,"eligibilityCriteria":441,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":442,"targetDuration":4,"studyType":21,"phases":444,"briefSummary":445,"conditions":446,"keywords":4,"overallStatus":30,"whyStopped":4,"lastUpdateSubmitDate":426,"lastUpdatePostDateStruct":448,"startDateStruct":450,"completionDateStruct":452,"leadSponsor":454,"locationsCount":66},"100342672","phase-3-pre-operative-srs-or-post-operative-srs-in-treating-cancer-patients-with-brain-metastases-100342672","NCT03741673","Pre-operative SRS or Post-operative SRS in Treating Cancer Patients With Brain Metastases","A Phase III Trial of Pre-Operative Stereotactic Radiosurgery (SRS) Versus Post-Operative SRS for Brain Metastases","Inclusion Criteria:\n\n* The primary lesion pre-operatively can have a maximum diameter of =\\\u003C 4 cm for single fraction and =\\\u003C 7 cm for multifraction therapy\n* Patients must be considered candidates for SRS within +\u002F- 30 days of surgical resection as defined by either history and physical (H\\&P) or presentation at brain metastasis tumor board conference note\n* Patients must have a Karnofsky performance scores \\>= 70 or Eastern Cooperative Oncology Group (ECOG) \\>= 2 within 30 days of enrollment\n* Patients must agree to randomization as documented by signing the Institutional Review Board (IRB) approved consent form\n* No radiographic evidence of leptomeningeal disease on MD Anderson Cancer Center (MDACC) departmental radiology report or study neuro-radiologist review\n* Documented history of malignancy\n\nExclusion Criteria:\n\n* Patients who have received prior radiation therapy to the brain for any reason\n* The primary tumor is small-cell lung cancer, lymphoma, leukemia, or multiple myeloma\n* For females, if they are pregnant or breast-feeding (The exclusion is made because gadolinium may be teratogenic in pregnancy)",{"count":443,"type":20},180,[23],"This phase III trial studies stereotactic radiosurgery (SRS) before surgery to see how well it works compared with SRS after surgery in treating patients with cancer that has spread to the brain (brain metastases). SRS is the delivery of focused, high-dose radiation given in a single session to the tumors, with a minimal dose given to uninvolved areas of the brain.",[447,27],"Malignant Neoplasm",{"date":449,"type":34},"2025-09-05",{"date":451,"type":34},"2018-11-08",{"date":453,"type":20},"2027-01-31",{"name":208,"class":41}]