[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"recurrent-glioma\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:recurrent-glioma":26},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,7,0,[8,43,70,97,121,142,167],{"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},"100505282","phase-2-testing-the-anti-cancer-drug-erdafitinib-for-brain-cancers-that-have-returned-or-progressed-following-treatment-100505282",false,"NCT05859334","Testing the Anti-cancer Drug Erdafitinib for Brain Cancers That Have Returned or Progressed Following Treatment","A Phase 2 Study of Erdafitinib in Patients With Recurrent or Progressive IDH-Wild Type Glioma With an FGFR-TACC Gene Fusion","Inclusion Criteria:\n\n* Patient must be \\>= 18 years of age\n* Patient must have histologically confirmed IDH-WT gliomas (grade 2-4) as per World Health Organization (WHO) 2016 or 2021 classification\n* Tumor tissue should be positive for FGFR-TACC gene fusion as per any local next generation sequencing (NGS) (Clinical Laboratory Improvement Act \\[CLIA\\]-approved) assay described in background section\n* The disease should be recurrent or progressive glioma after initial anti-tumor treatment with at least 1 line of treatment including surgical resection, radiation therapy and\u002For chemotherapy\n* For patients with WHO grade 3 or 4 glioma and progressive disease \\\u003C 12 weeks after completion of chemoradiotherapy, progression can be defined by the following set of criteria:\n\n  * New enhancement outside of the radiation field (beyond the high-dose region or 80% isodose line)\n  * If there is unequivocal evidence of viable tumor on histopathologic sampling (e.g., solid tumor areas. i.e., \\> 70% tumor cell nuclei in areas), high or progressive increase in Ki-67 proliferation index compared with prior biopsy, or evidence for histologic progression or increased anaplasia in tumor)\n* For patients with WHO grade 3 or 4 glioma and progressive disease \\>= 12 weeks after completion of chemoradiotherapy, progression can be defined by the following set of criteria:\n\n  * New contrast-enhancing lesion outside of radiation field on decreasing, stable, or increasing doses of corticosteroids\n  * Increase by \\>= 25% in the sum of the products of perpendicular diameters between the first post-radiotherapy scan, or a subsequent scan with smaller tumor size, and the scan at 12 weeks or later on stable or increasing doses of corticosteroids\n  * For patients receiving antiangiogenic therapy, significant increase in T2\u002Ffluid attenuated inversion recovery (FLAIR) non-enhancing lesion may also be considered progressive disease. The increased T2\u002FFLAIR must have occurred with the patient on stable or increasing doses of corticosteroids compared with baseline scan or best response after initiation of therapy and not be a result of comorbid events (e.g., effects of radiation therapy, demyelination, ischemic injury, infection, seizures, postoperative changes, or other treatment effects)\n* For patients with WHO grade 2 glioma progression is defined by any one of the following:\n\n  * Development of new lesions or increase of enhancement (radiological evidence of malignant transformation)\n  * A 25% increase of the T2 or FLAIR non-enhancing lesion on stable or increasing doses of corticosteroids compared with baseline scan or best response after initiation of therapy, not attributable to radiation effect or to comorbid events\n* There must be measurable disease (enhancing or non-enhancing as per Response Assessment in Neuro-Oncology \\[RANO\\] or RANO-low-grade glioma \\[LGG\\] criteria), as evaluated on pre-treatment MRI\n* Patient understands the procedures and investigational nature of the study drug and agrees to comply with study requirements by providing written informed consent\n* Patient must have Eastern Cooperative Oncology Group (ECOG) performance status =\\\u003C 2 (or Karnofsky \\>= 60%)\n* Absolute neutrophil count \\>= 1000\u002FuL\n* Hemoglobin \\> 8 g\u002FdL (Patients are allowed to be transfused to this level)\n* Platelets \\>= 100 x 10\\^9\u002FL\n* Serum total bilirubin =\\\u003C 1.5 x upper limit of normal (ULN), unless considered due to Gilbert's disease or disease involvement following approval by the medical monitor\n* Aspartate aminotransferase (AST) (serum glutamic-oxaloacetic transaminase \\[SGOT\\])\u002Falanine aminotransferase (ALT) (serum glutamic pyruvic transaminase \\[SGPT\\]) =\\\u003C 3 x institutional ULN\n* Creatinine clearance \\> 30 mL\u002Fmin (patients with mild or moderate renal impairment) based on the Cockroft-Gault glomerular filtration rate (GFR) estimation\n* Patient must have normal serum phosphate level as per local laboratory parameters. (Medical management allowed)\n* Patient must be recovered from any clinically relevant toxic effects of any prior surgery, radiotherapy, or chemotherapy treatment with temozolomide\n* Human immunodeficiency virus (HIV)-infected patients on effective anti-retroviral therapy with undetectable viral load within 6 months are eligible for this trial\n* For patients with evidence of chronic hepatitis B virus (HBV) infection, the HBV viral load must be undetectable on suppressive therapy, if indicated\n* Patients with a history of hepatitis C virus (HCV) infection must have been treated and cured. For patients with HCV infection who are currently on treatment, they are eligible if they have an undetectable HCV viral load\n* Patients should be New York Heart Association Functional Classification class 2B or better\n* The effects of erdafitinib on the developing human fetus are unknown. For this reason and because FGFR inhibitors are known to be teratogenic, 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, for the duration of study participation, and one month after completion of erdafitinib administration. Should a woman become pregnant or suspect she is pregnant while she or her partner is participating in this study, she should inform her treating physician immediately. Men treated or enrolled on this protocol must also agree to use adequate contraception prior to the study, for the duration of study participation, and one month after completion of erdafitinib administration\n* Ability to understand and the willingness to sign a written informed consent document. Legally authorized representatives may sign and give informed consent on behalf of study participants\n\nExclusion Criteria:\n\n* Patients who are receiving any other investigational agents\n* History of allergic reactions attributed to compounds of similar chemical or biologic composition to erdafitinib\n* Patients requiring any medications or substances that are moderate CYP2C9 inducers and strong CYP3A4 inducers are ineligible. Because the lists of these agents are constantly changing, it is important to regularly consult a frequently-updated medical reference. As part of the enrollment\u002Finformed consent procedures, the patient will be counseled on the risk of interactions with other agents, and what to do if new medications need to be prescribed or if the patient is considering a new over-the-counter medicine or herbal product\n* Patients with uncontrolled intercurrent illness\n* Pregnant women are excluded from this study because erdafitinib is an FGFR inhibitor agent with the potential for teratogenic or abortifacient effects. Because there is an unknown but potential risk for adverse events in nursing infants secondary to treatment of the mother with erdafitinib, breastfeeding should be discontinued if the mother is treated with erdafitinib\n* Current central serous retinopathy (CSR) or retinal pigment epithelial detachment of any grade\n* Corrected QT interval (QTc) prolongation as confirmed by electrocardiography (ECG) at screening (Fridericia; QTc \\> 480 milliseconds)\n* Patients who have previously received FGFR inhibitors","ALL","18 Years",{"count":19,"type":20},30,"ESTIMATED","INTERVENTIONAL",[23],"PHASE2","This phase II trial tests how well erdafitinib works in controlling IDH-wild type (WT), FGFR-TACC gene fusion positive gliomas that have come back after a period of improvement (recurrent) or that are growing, spreading, or getting worse (progressive). Erdafitinib is in a class of medications called kinase inhibitors. It works by blocking the action of an abnormal FGFR protein that signals tumor cells to multiply. This may help keep tumor cells from growing and may kill them. Giving erdafitinib may help to slow the growth of, or to shrink, tumor cells in patients with recurrent or progressive IDH-wild type gliomas with FGFR-TACC gene fusion.",[26,27,28,29],"Recurrent Glioma","Recurrent WHO Grade 2 Glioma","Recurrent WHO Grade 3 Glioma","Recurrent WHO Grade 4 Glioma","RECRUITING","2026-06-16",{"date":33,"type":34},"2026-06-17","ACTUAL",{"date":36,"type":34},"2024-01-04",{"date":38,"type":20},"2026-10-23",{"name":40,"class":41},"National Cancer Institute (NCI)","NIH",27,{"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":60,"lastUpdatePostDateStruct":61,"startDateStruct":62,"completionDateStruct":64,"leadSponsor":66,"locationsCount":69},"100634599","phase-1-sitagliptin-in-recurrentprogressive-grade-4-glioma-100634599","NCT07541781","Sitagliptin in Recurrent\u002FProgressive Grade 4 Glioma","Targeting Myeloid-Derived Suppressor Cells in Patients With Recurrent\u002FProgressive Grade 4 Glioma: Phase 1 Trial of Sitagliptin","Inclusion Criteria:\n\nPhase 1b\n\n* Subjects must have histologically or cytologically confirmed WHO grade 4 glioma for which disease recurrence\u002Fprogression after first line therapy is diagnosed by the treating physician.\n* Subjects must not have received sitagliptin or bevacizumab for this disease.\n* Age \\>18 years\n* Performance status: ECOG performance status 0-2\n* Subjects must have adequate organ function and laboratory parameters within 21 days of study entry as defined below:\n\n  1. Hemoglobin ≥ 9 g\u002Fdl\n  2. Absolute neutrophil count ≥ 1,500\u002FmcL\n  3. Platelet count ≥ 100,000\u002FmcL\n  4. Total bilirubin \\\u003C 1.5 x institutional upper limit of normal (ULN)\n  5. AST (SGOT) ≤ 3 X institutional ULN\n  6. ALT (SGPT) ≤ 3 X institutional ULN\n  7. Calculated creatinine clearance \\> 50 mL\u002Fmin\n  8. Urine protein screened by urine analysis for urine protein creatinine (UPC) ratio.\n\n     For UPC ratio \\> 0.5, 24-hour urine protein must be obtained and must be \\\u003C 1000 mg.\n  9. Patients on full-dose anticoagulants (e.g., warfarin or LMW heparin) must meet both of the following criteria:\n\n     * No active bleeding or pathological condition that carries a high risk of bleeding (e.g., tumor involving major vessels or known varices)\n     * In-range INR (between 2 and 3) on a stable dose of oral anticoagulant or on a stable dose of low molecular weight heparin\n* Subjects must have the ability to understand and the willingness to sign a written informed consent document.\n* Women of childbearing potential, defined as any female who has experienced menarche and has not undergone surgical sterilization (e.g., hysterectomy, bilateral oophorectomy) and is not postmenopausal (≥12 months of spontaneous amenorrhea without an alternative medical cause), must have a negative pregnancy test within 7 days prior to treatment start. Women of childbearing potential and men must agree to use adequate contraception (hormonal or barrier method of birth control; abstinence) prior to study entry, for the duration of study participation, and through 30 days after the last dose of study drug. Should a woman become pregnant or suspect she is pregnant while participating in this study, she should inform her treating physician immediately. Men treated or enrolled on this protocol must also agree to use adequate contraception prior to the study, for the duration of study participation, and through 30 days after the last dose of study drug.\n* Subjects must be able to swallow whole tablets.\n* Participants must have controlled blood pressure, defined as systolic blood pressure ≤ 160 mg Hg or diastolic pressure ≤ 100 mg Hg, with or without antihypertensive therapy\n* Electrocardiogram without evidence of acute cardiac ischemia within 14 days prior study treatment\n* Subjects must have the following minimum intervals from prior treatments until planned treatment initiation of Cycle 1 Day 1:\n\n  * surgery - 4 weeks\n  * nitrosoureas - 6 weeks\n  * cytotoxic chemotherapy - standard intervals depending on the most recent regimen. i.e., for temozolomide 5 of 28, 23 days after most recent temozolomide; for temozolomide 21 of 28 days, 7 days after most recent dose; etoposide 14 of 21 days, 7 days after last dose.\n  * For drugs not listed, the research nurse, treating investigator, and principal investigator will determine the appropriate interval.\n  * Investigational therapy or non-cytotoxic GBM related therapy - 2 weeks\n* Subject is not deemed as a surgical candidate.\n\nPilot Phase\n\n* Subjects must have histologically or cytologically confirmed WHO grade 4 glioma for which disease recurrence\u002Fprogression after first line therapy is diagnosed by the treating physician.\n* Subjects must not have received sitagliptin or bevacizumab for this disease.\n* Age \\>18 years\n* Performance status: ECOG performance status 0-2\n* Subjects must have adequate organ function and laboratory parameters within 21 days of study entry as defined below:\n\n  1. Hemoglobin ≥ 9 g\u002Fdl\n  2. Absolute neutrophil count ≥ 1,500\u002FmcL\n  3. Platelet count ≥ 100,000\u002FmcL\n  4. Total bilirubin \\\u003C 1.5 x institutional upper limit of normal (ULN)\n  5. AST (SGOT) ≤ 3 X institutional ULN Version date: 30March2026 Page 16\n  6. ALT (SGPT) ≤ 3 X institutional ULN\n  7. Calculated creatinine clearance \\> 50 mL\u002Fmin\n  8. Urine protein screened by urine analysis for urine protein creatinine (UPC) ratio.\n\n     For UPC ratio \\> 0.5, 24-hour urine protein must be obtained and must be \\\u003C 1000 mg.\n  9. Patients on full-dose anticoagulants (e.g., warfarin or LMW heparin) must meet both of the following criteria:\n\n     * No active bleeding or pathological condition that carries a high risk of bleeding (e.g., tumor involving major vessels or known varices)\n     * In-range INR (between 2 and 3) on a stable dose of oral anticoagulant or on a stable dose of low molecular weight heparin\n* Subjects must have the ability to understand and the willingness to sign a written informed consent document.\n* Women of childbearing potential, defined as any female who has experienced menarche and has not undergone surgical sterilization (e.g., hysterectomy, bilateral oophorectomy) and is not postmenopausal (≥12 months of spontaneous amenorrhea without an alternative medical cause), must have a negative pregnancy test within 7 days of treatment start. Women of childbearing potential and men must agree to use adequate contraception (hormonal or barrier method of birth control; abstinence) prior to study entry, for the duration of study participation, and through 30 days after the last dose of study drug. Should a woman become pregnant or suspect she is pregnant while participating in this study, she should inform her treating physician immediately. Men treated or enrolled on this protocol must also agree to use adequate contraception prior to the study, for the duration of study participation, and through 30 days after the last dose of study drug.\n* Subjects must be able to swallow whole tablets.\n* Subjects must have controlled blood pressure, defined as systolic blood pressure ≤ 160 mg Hg or diastolic pressure ≤ 100 mg Hg, with or without antihypertensive therapy\n* Electrocardiogram without evidence of acute cardiac ischemia within 14 days prior to treatment start\n* Subjects must have the following minimum intervals from prior treatments until planned treatment initiation of Cycle 1Day1:\n\n  * surgery - 4 weeks\n  * nitrosoureas - 6 weeks\n  * cytotoxic chemotherapy - standard intervals depending on the most recent regimen. i.e., for temozolomide 5 of 28, 23 days after most recent temozolomide; for temozolomide 21 of 28 days, 7 days after most recent dose; etoposide 14 of 21 days, 7 days after last dose.\n  * For drugs not listed, the research nurse, treating investigator, and principal investigator will determine the appropriate interval.\n  * Investigational therapy or GBM related non-cytotoxic therapy - 2 weeks\n  * For bevacizumab (if for a different cancer) - 4 weeks from the expected date of protocol surgery\n* Subject is deemed as a surgical candidate.\n\nExclusion Criteria (for phase 1b and pilot phase)\n\n* Prior treatment toxicities not resolved to ≤ Grade 1 according to NCI CTCAE Version 5.0 except for alopecia and neuropathy.\n* Subjects receiving any other investigational agents.\n* History of allergic reactions attributed to compounds of similar chemical or biologic composition to sitagliptin or bevacizumab.\n* Subjects with 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* Known HIV-positive subjects on combination antiretroviral therapy are ineligible because of the potential for pharmacokinetic interactions with sitagliptin and\u002For bevacizumab. In addition, these subjects are at increased risk of lethal infections when treated with marrow suppressive therapy.\n* Other malignancy within the past 2 years with the exception of a) adequately treated basal cell carcinoma, squamous cell skin cancer, or thyroid cancer; b) carcinoma in situ of the cervix or vulva; c) prostate cancer of Gleason Score 6 or less with stable prostate specific antigen levels; or d) cancer considered cured by surgical resection or unlikely to impact survival during the duration of the study, such as localized transitional cell carcinoma of the bladder, or benign tumors of the adrenal or pancreas.\n* Significant chronic gastrointestinal disorder with diarrhea as a major symptom (e.g., Crohn's disease, malabsorption, or Grade ≥2 (National Cancer Institute \\[NCI\\] Common Terminology Criteria for Adverse Events Version 5.0 \\[CTCAE v.5.0\\] diarrhea of any etiology at screening).\n* Known active infection with hepatitis B or hepatitis C virus.\n* Pregnant or breastfeeding.\n* Subjects who receive insulin or sulfonylurea for diabetes mellitus.\n* Subjects with history of type 1 diabetes, uncontrolled type 2 diabetes, hypoglycemia requiring medical intervention, or those who are deemed not suitable to receive sitagliptin at the discretion of the investigators.\n* Unable or unwilling to swallow tablets.\n* Evidence of significant medical illness, abnormal laboratory finding, or psychiatric illness\u002Fsocial situations that would, in the Investigator's judgment, make the patient inappropriate for this study.\n* Arterial ischemic event (e.g., unstable angina, myocardial infarction, stroke) within 6 months of study consent.\n* Subjects with history of hematologic bleeding disorder.",{"count":51,"type":20},45,[53],"PHASE1","Sitagliptin, when combined with standard-of-care drug bevacizumab, is being tested to 1) find out if it is effective at treating gliomas that have returned or progressed after treatment, and 2) find out what the highest dose of sitagliptin is appropriate to give when combined with bevacizumab.",[56,57,26,58,59],"Glioma","Glioblastoma","Recurrent Glioblastoma","Grade 4 Malignant Glioma of Brain (Disorder)","2026-06-15",{"date":33,"type":34},{"date":63,"type":34},"2026-06-11",{"date":65,"type":20},"2030-06-11",{"name":67,"class":68},"Kailin Yang, MD, PhD","OTHER",1,{"id":71,"slug":72,"hasResults":11,"nctId":73,"briefTitle":74,"officialTitle":74,"acronym":4,"eligibilityCriteria":75,"healthyVolunteers":76,"sex":16,"minAge":77,"maxAge":78,"enrollmentInfo":79,"targetDuration":4,"studyType":21,"phases":81,"briefSummary":83,"conditions":84,"keywords":4,"overallStatus":87,"whyStopped":4,"lastUpdateSubmitDate":88,"lastUpdatePostDateStruct":89,"startDateStruct":91,"completionDateStruct":93,"leadSponsor":95,"locationsCount":69},"100491235","early-phase-1-mefamp-for-imaging-system-a-amino-acid-transport-in-primary-and-metastatic-brain-tumors-100491235","NCT05676489","MeFAMP for Imaging System A Amino Acid Transport in Primary and Metastatic Brain Tumors","Inclusion Criteria for all cohorts:\n\n1. 18 years of age or older at the time of enrollment\n2. Females with childbearing potential must have a negative urine human chorionic gonadotropin (hCG) test on the day of procedure or a serum hCG test within 48 hours prior to the administration MeFAMP.\n3. Must have a life expectancy greater than 12 weeks.\n\nExclusion Criteria for all cohorts:\n\n1. Use of an investigational drug for any indication within 3 months prior to the imaging study.\n2. Pregnancy or breast feeding\n3. Inability to complete the PET scans.\n4. Significant renal or hepatic dysfunction (estimated glomerular filtration rate (GFR) \\\u003C 60 mL\u002Fmin)\n5. Any condition which may interfere with ability to participate in or complete all study-related activities as assessed by the study team.\n\n6.4.9.3. Inclusion criteria specific to Dosimetry Cohort\n\n1. Normal complete metabolic profile (CMP) and cell blood count (CBC) with differential at baseline.\n2. Normal ECG at baseline.\n\nExclusion criteria specific to Dosimetry Cohort\n\n1\\) Major medical problems (e.g. renal, hepatic, inflammatory) that could interfere with biodistribution of MeFAMP as assessed by the study team.\n\nInclusion Criteria specific to HGG Cohort\n\n1. Grade III or Grade IV glioma previously treated with radiation therapy\n2. Standard of care contrast-enhanced MRI showing an enhancing lesion at least 1-cm in maximum dimension that is equivocal or suspicious for recurrent glioma.\n3. Eastern Cooperative Oncology Group (ECOG) performance score of 2 or better\n\nInclusion Criteria specific to Metastasis Cohort\n\n1. At least one brain metastasis from melanoma, lung cancer (small or non-small cell), or breast cancer measuring at least 1-cm in maximum dimension on contrast-enhanced MRI\n2. Plan for stereotactic radiation therapy within 2 weeks of initial MeFAMP-PET\u002FMRI scan.\n3. ECOG performance score of 2 or better\n\nInclusion of Women and Minorities\n\nPatients 18 years of age or older will be eligible for study participation. No other discriminatory factors, including age, sex, or ethnic background will be used to determine eligibility. Every effort will be made to ensure that minorities are recruited for study participation.",true,"18 Months","89 Years",{"count":80,"type":20},28,[82],"EARLY_PHASE1","This first-in-human study will establish the human safety and radiation dosimetry of the system A amino acid transport substrate, (R)-3-\\[F-18\\]fluoro-2-methyl-2-(methylamino)propanoic acid (\\[F-18\\]MeFAMP), for positron emission tomography (PET) imaging of primary and metastatic brain tumors. This study will include 3 cohorts: healthy volunteers for whole body dosimetry estimates (n=6-8, Dosimetry Cohort), patients undergoing evaluation for recurrent high grade glioma after radiation therapy (n=10, high grade glioma (HGG) Cohort), and patients with brain metastases from extra-cranial solid tumors before and after radiation therapy (n=10, Metastasis Cohort). Exploratory assessment of the diagnostic accuracy of MeFAMP for distinguishing recurrent\u002Fprogressive brain tumors from radiation-related treatment effects will also be performed for subsequent trial design. The study will complete accrual and safety assessment in the Dosimetry Cohort before recruiting for the HGG and Metastasis Cohorts.",[85,26,86],"Healthy Volunteers","Brain Metastases From Extra-cranial Solid Tumors","NOT_YET_RECRUITING","2026-05-30",{"date":90,"type":34},"2026-06-02",{"date":92,"type":20},"2027-04-01",{"date":94,"type":20},"2029-08-30",{"name":96,"class":68},"University of Alabama at Birmingham",{"id":98,"slug":99,"hasResults":11,"nctId":100,"briefTitle":101,"officialTitle":102,"acronym":103,"eligibilityCriteria":104,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":105,"targetDuration":4,"studyType":21,"phases":106,"briefSummary":108,"conditions":109,"keywords":4,"overallStatus":30,"whyStopped":4,"lastUpdateSubmitDate":111,"lastUpdatePostDateStruct":112,"startDateStruct":114,"completionDateStruct":116,"leadSponsor":118,"locationsCount":120},"100546639","proton-pulsed-reduced-dose-rate-radiotherapy-for-recurrent-cns-malignancies-trial-100546639","NCT06397560","PrOton Pulsed reduCed dOse Rate Radiotherapy for Recurrent CNS maligNancies Trial","PrOton Pulsed reduCed dOse Rate Radiotherapy for Recurrent CNS maligNancies (POPCORN) Trial","POPCORN","Inclusion Criteria:\n\n* Karnofsky performance status ≥ 50\n* Histologically-confirmed or radiographic evidence of recurrent \u002F progressive glioma\n* Prior treatment with radiotherapy to a minimum dose of 45 Gy\n* At least 6 months or greater between completion of prior radiotherapy and enrollment in this study. If prospective participants have not passed an interval of at least 6 months, they may still be eligible if they meet one or more of the following criteria:\n\n  1. New areas of tumor outside the original radiotherapy fields as determined by the investigator.\n  2. Histologic confirmation of tumor through biopsy or resection AND an interval of at least 90 days between completion of radiotherapy and enrollment.\n  3. Nuclear medicine imaging, magnetic resonance (MR) spectroscopy, or MR perfusion imaging consistent with true progressive disease, rather than radiation necrosis obtained within 28 days of enrollment AND an interval of at least 90 days between completion of radiotherapy and enrollment.\n* Must have recovered from grade 3+ toxicities of prior therapy and there must be a minimum time of 28 days prior to enrollment from the administration of any investigational agent or prior cytotoxic therapy\n* Must not be pregnant (positive pregnancy test) or breastfeeding. Must agree to use of highly effective contraception during radiotherapy treatment and for an additional 6 months. Should a participant become pregnant or suspect that they are pregnant while participating in this study, they should notify the treating physician immediately.\n\nHighly effective and acceptable forms of contraception are:\n\n* Male condom plus spermicide\n* Cap plus spermicide\n* Diaphragm plus spermicide\n* Copper T\n* Progesterone T\n* Levonorgestrel-releasing intrauterine system (e.g., Mirena®)\n* Implants\n* Hormone shot or injection\n* Combined pill\n* Mini-pill\n* Patch\n\nIndividuals who meet any of the following criteria will not need contraception:\n\n* Individuals assigned male at birth\n* Amenorrhoeic for 1 year or more following cessation of exogenous hormonal treatments\n* Luteinizing hormone (LH) and follicle stimulating hormone (FSH) levels in the postmenopausal range for individuals under 50\n* Radiation-induced oophorectomy with last menses \\> 1 year ago\n* Chemotherapy-induced menopause with \\>1 year interval since last menses\n* Surgical sterilization (bilateral oophorectomy or hysterectomy)\n\nExclusion Criteria:\n\n* Two or more courses of prior radiotherapy\n* Inability to undergo an MRI with contrast\n* Leptomeningeal evidence of recurrent disease\n* Multi-focal disease\n* Any other condition that may put a participant at higher risk, at the discretion of the investigator.",{"count":80,"type":20},[107],"NA","The purpose of this research study is to see if a specific type of radiation therapy, called \"proton pulsed reduced dose rate\" or \"PRDR radiotherapy\" has any benefits at dose levels and number of fractions thought to be acceptable in earlier research studies. The researchers want to find out what effects (good and bad) PRDR has on people with cancer in the brain called a \"recurrent high-grade glioma\" meaning that it grows fast, can spread quickly, and it has come back or gotten worse after being treated previously.",[56,110,26],"Glioma, Malignant","2026-05-28",{"date":113,"type":34},"2026-06-01",{"date":115,"type":34},"2025-04-30",{"date":117,"type":20},"2029-06",{"name":119,"class":68},"Baptist Health South Florida",2,{"id":122,"slug":123,"hasResults":11,"nctId":124,"briefTitle":125,"officialTitle":126,"acronym":4,"eligibilityCriteria":127,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":128,"targetDuration":4,"studyType":21,"phases":130,"briefSummary":131,"conditions":132,"keywords":4,"overallStatus":30,"whyStopped":4,"lastUpdateSubmitDate":133,"lastUpdatePostDateStruct":134,"startDateStruct":136,"completionDateStruct":138,"leadSponsor":140,"locationsCount":120},"100598689","a-digital-treatment-platform-for-the-delivery-of-home-based-sequential-therapy-in-patients-with-glioma-100598689","NCT07074756","A Digital Treatment Platform for the Delivery of Home-Based Sequential Therapy in Patients With Glioma","Neuro-Oncology Anywhere: Glioma Home-Based Sequential Therapy (GHoST) Protocol","Inclusion Criteria:\n\n* Age ≥ 18 years\n* Diagnosis of glioma and intention to treat with either new or ongoing systemic therapy for at least 6 months.\n\n  * NOTE: Patient may be enrolled following completion of surgery and\u002For radiation therapy for newly diagnosed or recurrent tumor.\n  * NOTE: Any number of prior recurrences is permitted\n* Eastern Cooperative Oncology Group (ECOG) performance status of 0, 1, or 2, AND Karnofsky performance status (KPS) of ≥ 60\n* Expected survival ≥ 6 months in the opinion of treatment team\n* Willing and able to adhere with the protocol for the duration of the study including undergoing treatment, and attending scheduled visits, and examinations\n* Negative pregnancy test ≤ 8 days prior to registration for persons of childbearing potential only\n* Provide written informed consent\n* Ability to complete assessments and questionnaires by themselves or with assistance\n\nExclusion Criteria:\n\n* Pregnant or nursing, imprisoned, or lacking capacity for understanding\n* Uncontrolled and\u002For intercurrent illness or other condition which limits safety of or compliance with study proceedings",{"count":129,"type":20},120,[107],"This clinical trial tests how well a digital treatment platform using a mobile application works for the delivery of home-based sequential therapy in patients with glioma. Access to specialized neuro-oncology care in the United States for patients with glioma is critically deficient. Care at centers with neuro-oncology specialists is associated with improved survival outcomes, yet many patients have limited access due to distance, disease-related disability, or lack of financial resources. The application provides patients continuous access to their care team in the home setting. A digital treatment platform may increase clinical trial participation and accelerate development of novel therapeutics while addressing a great health disparity in patients with glioma.",[56,26],"2026-03-24",{"date":135,"type":34},"2026-03-27",{"date":137,"type":34},"2025-09-12",{"date":139,"type":20},"2028-08-31",{"name":141,"class":68},"Mayo Clinic",{"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":155,"overallStatus":30,"whyStopped":4,"lastUpdateSubmitDate":158,"lastUpdatePostDateStruct":159,"startDateStruct":161,"completionDateStruct":163,"leadSponsor":165,"locationsCount":69},"100489995","phase-1-carv3-team-e-t-cells-in-glioblastoma-100489995","NCT05660369","CARv3-TEAM-E T Cells in Glioblastoma","INCIPIENT: INtraventricular CARv3-TEAM-E T Cells for PatIENTs With GBM","Inclusion Criteria:\n\n* Safety Run In Arm and ARM 1: Recurrent GBM, EGFRvIII mutant\n\n  * Participants must have histologically confirmed recurrent GBM or molecular features of GBM with presence of EGFRvIII mutation detected at initial diagnosis. MGMT methylated, unmethylated, or unknown is allowed.\n  * Participants must be at first progression or recurrence and plan is for biopsy or surgical debulking. Participants must have at least received prior radiation. Prior temozolomide is not required if the participant is MGMT unmethylated.\n\nParticipants must be 2 weeks from prior alkylating therapy or immunotherapy and ≥ 5 half-lives from another investigational agent before proceeding with collection or treatment. No washout is required from radiation since participants will need histological confirmation of recurrence to participate.\n\n* ARM 2: Newly Diagnosed GBM, EGFRvIII mutant (will only open once safety is confirmed in Arms 1 and 3)\n\n  * Participants must have histologically confirmed newly diagnosed GBM with presence of EGFRvIII mutation and their tumors must be MGMT unmethylated.\n  * Treatment planned with involved field radiation alone without concomitant or sequential temozolomide.\n* ARM 3: Recurrent GBM, EGFRvIII negative\n\n  * Participants must have histologically confirmed recurrent GBM with EGFR amplification but no EGFRvIII mutation based on initial diagnostic tissue.\n  * Participants must be at first recurrence and plan is for biopsy or surgical debulking. Participants must have at least received prior radiation. Prior temozolomide is not required if the participant is MGMT unmethylated.\n\nParticipants must be 2 weeks from prior alkylating therapy or immunotherapy and ≥ 5 half-lives from another investigational agent. No washout is required from radiation since participants will need histological confirmation of recurrence to participate.\n\n* ARM 1: Recurrent GBM, EGFRvIII mutant and ARM 3: Recurrent GBM, EGFRvIII negative:\n\n  * Must be at least 3 months from completion of radiation or evidence of progression is outside the high dose radiation field.\n* Safety Run-In Arm and ARM 1: Recurrent GBM, EGFRvIII mutant and ARM 3: Recurrent GBM, EGFRvIII negative:\n\n  * Participants must have measurable disease, defined as at least one lesion ≥10 mm (≥1 cm) with MRI. See Section 11 (Measurement of Effect) for the evaluation of measurable disease.\n* ALL ARMS:\n\n  * Patients cannot have posterior fossa or intramedullary spine-only disease. Leptomeningeal disease is allowed anywhere in the neuroaxis. See Section 11 (Measurement of Effect) for the evaluation of measurable disease.\n  * Resolution of AEs from any prior systemic anticancer therapy or radiotherapy to Grade 1 or baseline (except Grade 2 alopecia and Grade 2 sensory neuropathy)\n  * Medically able and willing to undergo placement of an Ommaya reservoir.\n  * Steroid dose anticipated to be ≤ 4 mg of dexamethasone a day or equivalent at time of first CAR-v3-TEAM-E infusion.\n  * Age ≥18 years\n  * Karnofsky ≥60%\n  * Must be able to undergo an MRI with contrast.\n  * Life expectancy of greater than 3 months.\n  * Participants must have adequate organ and marrow function as defined below:\n\n    * Absolute neutrophil count ≥1,000\u002FmcL\n    * Platelets ≥80,000\u002FmcL\n    * Total bilirubin ≤ institutional upper limit of normal (ULN); For patients with Gilbert's syndrome, total bilirubin can be ≤ 3xULN.\n    * AST(SGOT)\u002FALT(SGPT) ≤3 × institutional ULN\n    * CrCl ≥ 60 mL\u002Fmin\n  * Participant has no prior history of malignancy, unless the subject has been free of the disease for ≥5 years with the exception of the following noninvasive malignancies:\n\n    * Basal cell carcinoma of the skin\n    * Squamous cell carcinoma of the skin\n    * Carcinoma in situ of the cervix\n    * Carcinoma in situ of the breast\n    * Incidental histologic finding of prostate cancer (T1a or T1b) or prostate cancer that is curative\n  * Left ventricular ejection fraction \\>50% as determined by TTE.\n  * The effects of CARv3-TEAM-E on the developing human fetus are unknown. For this reason, 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 the duration of study participation. Should a woman become pregnant or suspect she is pregnant while she or her partner is participating in this study, she should inform her treating physician immediately. Men treated or enrolled on this protocol must also agree to use adequate contraception prior to the study, for the duration of study participation, and 4 months after completion of CARv3-TEAM-E administration.\n  * Ability to understand and the willingness to sign a written informed consent document.\n\nExclusion Criteria:\n\n* Intraparenchymal posterior fossa disease\n* Intramedullary spinal disease as the only site of disease.\n* Prior EGFRvIII targeted therapies.\n* Prior bevacizumab treatment.\n* Treatment with an any prior gene-therapy or gene-modified cellular therapy.\n* Patients with a VP shunt or patients needing a shunt in the immediate future are excluded from participating\n* Ongoing treatment with chronic immunosuppressants (e.g., cyclosporine or systemic steroids above physiologic dosing). Intermittent topical, inhaled, or intranasal corticosteroids are allowed\n* Participants who have not recovered from adverse events due to prior anti-cancer therapy (i.e., have residual toxicities \\> Grade 1) with the exception of alopecia.\n* Participants who are receiving any other investigational agents.\n* History of allergic reactions attributed to compounds of similar chemical or biologic composition to CARv3-TEAM-E (ex. cetuximab).\n* Participants with uncontrolled intercurrent illness.\n* Human immunodeficiency virus (HIV)-infected participants are not eligible.\n* Participants with evidence of chronic hepatitis B virus (HBV) infection or active hepatitis C virus (HCV) infection are not eligible.\n* Participants with psychiatric illness\u002Fsocial situations that would limit compliance with study requirements.\n* Pregnant women are excluded from this study because there is an unknown but potential risk for adverse events in nursing infants secondary to treatment of the mother with CARv3-TEAM-E , breastfeeding should be discontinued if the mother is treated with CARv3-TEAM-E.\n* For Arm 2, prior to CARv3-TEAM-E Infusion, the following criteria should be confirmed in addition to the relevant criteria above:\n\n  * Participants must have completed 75% of the planned 6 weeks of involved field radiation without temozolomide\n  * Tumor location and size criteria as in 3.1.7 above.\n  * Prior cancer directed therapy other than radiation is not allowed.",{"count":150,"type":20},21,[53],"The goal of this research study is to determine the best dose of CARv3-TEAM-E T Cells for treating participants with glioblastoma.\n\nThe name of the treatment intervention used in this research study is:\n\n-CARv3-TEAM-E T Cells (or Autologous T lymphocytes).",[57,154,58,26],"Malignant Glioma",[57,154,58,26,156,157],"Immunotherapy","Gene-Transfer Therapy","2026-02-02",{"date":160,"type":34},"2026-02-04",{"date":162,"type":34},"2023-03-22",{"date":164,"type":20},"2027-09-01",{"name":166,"class":68},"Marcela V. Maus, M.D.,Ph.D.",{"id":168,"slug":169,"hasResults":11,"nctId":170,"briefTitle":171,"officialTitle":172,"acronym":4,"eligibilityCriteria":173,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":174,"targetDuration":4,"studyType":21,"phases":176,"briefSummary":177,"conditions":178,"keywords":4,"overallStatus":30,"whyStopped":4,"lastUpdateSubmitDate":180,"lastUpdatePostDateStruct":181,"startDateStruct":183,"completionDateStruct":185,"leadSponsor":187,"locationsCount":190},"100423524","phase-1-a-study-of-gnc-039-a-tetra-specific-antibody-in-participants-with-relapsedrefractory-or-metastatic-solid-tumors-100423524","NCT04794972","A Study of GNC-039, a Tetra-specific Antibody, in Participants With Relapsed\u002FRefractory or Metastatic Solid Tumors","An Open-Label, Multi-Center, Phase I Study to Evaluate the Safety, Tolerability，Pharmacokinetic\u002FPharmacodynamics and Anti-tumor Activity of Tetra-specific Antibody GNC-039 in Participants With Relapsed\u002FRefractory or Metastatic Solid Tumors","Inclusion Criteria:\n\n1. After failure of standard treatment (surgery, stupp regimen), subjects with diagnosed recurrent high-grade glioma (WHO Grade III-IV), or other recurrent\u002Frefractory or metastatic solid tumors can understand the informed consent, voluntarily participate in and sign the informed consent.\n2. No gender limitation.\n3. Age: ≥18 years old.\n4. KPS≥60 points.\n5. The expected survival as determined by the researchers was ≥3 months.\n6. Hematological functions meet the following requirements: neutrophil absolute count (ANC) ≥1.5×109\u002FL, platelet count ≥75×109\u002FL, hemoglobin ≥90g\u002FL.\n7. Renal function meets the following requirements: creatinine (Cr) ≤1.5 ULN and creatinine clearance (Ccr) ≥50 mL\u002Fmin (based on the calculation criteria of the study center), urinary protein ≤2+ or \\\u003C 1000mg\u002F24h (urine).\n8. Liver functions meet the following requirements: Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) ≤3.0×ULN; Total bilirubin ≤1.5×ULN (Gilbert's syndrome ≤3×ULN).\n9. Coagulation function: fibrinogen ≥1.5g\u002FL; Activated partial thromboplastin time (APTT) ≤1.5×ULN; Prothrombin time (PT) ≤1.5×ULN.\n10. A fertile female subject or a fertile male subject with a fertile partner must use highly effective contraception from the date of informed consent until 12 weeks after the last dosing. Serum pregnancy tests must be negative for fertile female subjects within -10 to -3 days prior to initial dosing.\n11. Subject is able and willing to comply with visits, treatment plans, laboratory tests, and other study-related procedures as specified in the study protocol.\n12. For glioma patients: a. There must be a pathological diagnosis and a definite diagnosis of high-grade glioma; b. MRI diagnosis supported recurrence; c. Presence of at least one measurable tumor lesion according to RANO criteria; Or subjects receiving surgical treatment after recurrence; d. Archived primary or recurrent tumor tissue or sections that can be submitted to the Center for review (no less than 10 pathological white slices of 3-5μm or corresponding tissue blocks should be provided). If patients are unable to provide tumor tissue specimens, the Center may inform the sponsor and enroll them.\n13. For patients with other solid tumors: a. Histologically or cytologically confirmed recurrent\u002Frefractory or metastatic solid tumors with disease progression confirmed by imaging or other objective evidence after standard treatment; Or subjects with refractory solid tumors who cannot tolerate standard therapy or have contraindications to standard therapy; b. Must have at least one measurable lesion that meets the RECIST v1.1 definition.\n\nExclusion Criteria:\n\n1. Patients who are allergic to immunoglobulin or any component of the injectable formulation of GNC-039.\n2. Patients with active infections requiring intravenous antibiotics who did not complete treatment 1 week prior to enrollment, except those who received prophylactic antibiotics for puncture or biopsy.\n3. Human immunodeficiency virus antibody (HIVAb) positive, active tuberculosis, active hepatitis B virus infection (HBsAg positive or HBcAb positive with HBV-DNA copy number ≥ULN) or hepatitis C virus infection (HCV-RNA≥ULN).\n4. Toxicity from prior antitumor therapy did not decrease to ≤ grade 1 as defined in CTCAE version 5.0 (except for toxicities that the investigators judged to be of no safety risk, such as alopecia, grade 2 peripheral neurotoxicity, stable hypothyroidism after hormone replacement therapy, etc.).\n5. Patients at risk for active autoimmune diseases, or with a history of autoimmune diseases that may involve the central nervous system, Including but not limited to Crohn's disease, ulcerative colitis, systemic lupus erythematosus, Wegener syndrome, autoimmune hepatitis, systemic sclerosis, Hashimoto's thyroiditis, autoimmune vasculitis, autoimmune neuropathy (Guillain-Barre syndrome), etc. Exceptions include type I diabetes mellitus, hypothyroidism stable on hormone replacement therapy (including hypothyroidism caused by autoimmune thyroid disease), psoriasis or vitiligo that do not require systemic therapy, and autoimmune diseases caused by B cells and anti-autoimmune antibodies.\n6. Lung disease defined by NCI-CTCAE v5.0 as ≥ grade 3, including patients with resting dyspnea, or in need of continuous oxygen therapy, or with a history of interstitial lung disease (ILD).\n7. Previous organ transplant recipients.\n8. History of severe cardiovascular and cerebrovascular diseases, including but not limited to: severe cardiac rhythm or conduction abnormalities, such as ventricular arrhythmia requiring clinical intervention, degree III atrioventricular block, etc.; At rest, the QT interval was prolonged (QTc \\> 450 msec in men or 470 msec in women); Acute coronary syndrome, congestive heart failure, aortic dissection, stroke, or other grade 3 or higher cardiovascular and cerebrovascular events occurred within 6 months prior to initial administration; There is heart failure ≥II on the New York Heart Association (NYHA) cardiac function scale.\n9. Thrombotic events such as deep vein thrombosis, arterial thrombosis, and pulmonary embolism occurred within 6 months prior to screening.\n10. Other conditions deemed unsuitable for participation in this clinical trial by the investigator.\n11. Brain gliomas: a. Patients who underwent surgery, chemotherapy, targeted and immunotherapy, iodine in vivo radiation, radiation therapy, or planned to undergo radiation therapy during the trial within 4 weeks of enrollment or 5 half-lives, whichever is shorter; b. Patients who had received intracranial lesion puncture biopsy within 7 days prior to enrollment; c. Received other investigational drugs or treatments that are not on the market within 4 weeks prior to enrollment; d. There was a history of central nervous system bleeding\u002Finfarction not associated with antineoplastic agents, such as stroke or intracranial and ocular bleeding (including embolic stroke), during the 6 months prior to enrollment.\n12. For other solid tumors: a. Received chemotherapy, antibody therapy, molecular-targeted therapy, or investigational drugs within 4 weeks or 5 half-lives (whichever is shorter) of initial administration; b. Patients who underwent major surgery within 28 days prior to administration of the drug or were scheduled to undergo major surgery during the study period (except for procedures such as puncture or lymph node biopsy); c. poorly controlled hypertension (systolic blood pressure \\> 150 mmHg or diastolic blood pressure \\> 100 mmHg); d. Previous or associated central nervous system lesions, including but not limited to: paralysis, stroke (except those with lacunar infarction indicated by imaging examination but without treatment), severe brain injury, senile dementia, Parkinson's disease, organic brain syndrome, and psychosis; e. Received other investigational drugs or treatments that were not on the market within 4 weeks prior to enrollment.",{"count":175,"type":20},60,[53],"In this study, the safety, tolerability and preliminary effectiveness of GNC-039 in patients with relapsed\u002Frefractory or metastatic glioma or other solid tumors will be investigated to assess the dose-limiting toxicity (DLT), maximum tolerated dose (MTD) or maximum administered dose (MAD) for MTD is not reached of GNC-039.",[26,179],"Solid Tumor","2025-09-26",{"date":182,"type":34},"2025-09-29",{"date":184,"type":34},"2021-04-14",{"date":186,"type":20},"2026-12",{"name":188,"class":189},"Sichuan Baili Pharmaceutical Co., Ltd.","INDUSTRY",6]