[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100295151":3},{"organization":4,"armGroups":7,"interventions":23,"overallOfficials":37,"centralContacts":41,"locations":48,"responsibleParty":64,"collaborators":46,"id":67,"slug":68,"hasResults":69,"nctId":70,"briefTitle":71,"officialTitle":72,"acronym":46,"eligibilityCriteria":73,"healthyVolunteers":69,"sex":74,"minAge":75,"maxAge":46,"enrollmentInfo":76,"targetDuration":46,"studyType":79,"phases":80,"briefSummary":82,"conditions":83,"keywords":46,"overallStatus":50,"whyStopped":46,"lastUpdateSubmitDate":85,"lastUpdatePostDateStruct":86,"startDateStruct":89,"completionDateStruct":91,"leadSponsor":93,"locationsCount":94},{"fullName":5,"class":6},"University of Cincinnati","OTHER",[8,14,19],{"label":9,"type":10,"description":11,"interventionNames":12},"Letrozole","EXPERIMENTAL","The BN-16-01 main study treatment starting dose will be 2.5mg administered orally once daily. Daily doses up to 10mg and single doses of 30mg have been shown to be safe in prior studies and therefore we expect that letrozole doses up to 20mg in this study will be safe.\n\nThe recommended phase II dose (RP2D) will be considered the dose that results in ≥ 2uM letrozole concentration in the tumor or the highest dose achieved (20mg daily for cohort level 7) with \\\u003C 2\u002F6 patients with DLTs. This dose will be planned for future phase II studies to determine potential efficacy.",[13],"Drug: Letrozole Oral Tablet",{"label":15,"type":10,"description":16,"interventionNames":17},"Letrozole and temozolomide","Phase 1 expansion cohort of letrozole 15mg administered in combination with 50 mg\u002Fm2 metronomic temozolomide (TMZ) in patients with high grade gliomas. Letrozole 15mg will be administered orally once daily for a 7-day lead-in period. After 7 days subjects will continue letrozole in combination 50 mg\u002Fm2 TMZ administered orally once daily.",[13,18],"Drug: Temozolomide",{"label":20,"type":10,"description":21,"interventionNames":22},"Previously Received letrozole and temozolomide","Phase 1 expansion cohort of two identified subjects with gliomas who previously participated in the main study UCCI-BN-16-01 who received as physician's choice of treatment 50 mg\u002Fm2 TMZ in combination with dosing of 15 mg letrozole.",[13,18],[24,31],{"type":25,"name":26,"description":27,"armGroupLabels":28,"otherNames":29},"DRUG","Letrozole Oral Tablet","Administration: Letrozole will be given orally once daily.",[9,15,20],[30],"Femara",{"type":25,"name":32,"description":33,"armGroupLabels":34,"otherNames":35},"Temozolomide","50 mg\u002Fm2 TMZ administered orally once daily",[15,20],[36],"Temodar",[38],{"name":39,"affiliation":5,"role":40},"Trisha Wise-Draper, MD, PhD","PRINCIPAL_INVESTIGATOR",[42],{"name":43,"role":44,"phone":45,"phoneExt":46,"email":47},"UC Cancer Center Clinical Trials Office","CONTACT","513-584-7698",null,"cancer@uchealth.com",[49],{"facility":5,"status":50,"city":51,"state":52,"zip":53,"country":54,"countryCode":55,"cosmosGeoPoint":56,"geoPoint":61,"contacts":62},"RECRUITING","Cincinnati","Ohio","45267","United States","US",{"type":57,"coordinates":58},"Point",[59,60],-84.51439,39.12711,{"lat":60,"lon":59},[63],{"name":39,"role":44,"phone":46,"phoneExt":46,"email":46},{"type":40,"investigatorFullName":65,"investigatorTitle":66,"investigatorAffiliation":5,"oldNameTitle":46,"oldOrganization":46},"Trisha Wise-Draper","Principal Investigator","100295151","early-phase-1-study-of-letrozole-in-recurrent-gliomas-100295151",false,"NCT03122197","Study of Letrozole in Recurrent Gliomas","A Phase 0\u002F1 Pharmacokinetic and Pharmacodynamics and Safety and Tolerability Study of Letrozole in Combination With Standard Therapy in Recurrent High Grade Gliomas","Inclusion Criteria\n\n1. Radiographically, histologically or cytologically confirmed recurrent brain high grade glioma with plan for resection or biopsy.\n\n   \\- Inclusion #1 for Sub-study Only: Radiographically, histologically or cytologically confirmed recurrent brain high grade glioma.\n2. Age \\>18 years.\n3. ECOG performance status 0 -2 (Karnofsky \\>60%, see Appendix A).\n4. CBC\u002Fdifferential obtained within 28 days prior to registration on study, with adequate bone marrow function defined as follows:\n\n   * Absolute neutrophil count (ANC) ≥ 1,000 cells\u002Fmm3;\n   * Platelets ≥ 100,000 cells\u002Fmm3;\n   * Hemoglobin ≥ 8.0 g\u002Fdl (Note: The use of transfusion or other intervention to achieve Hgb ≥ 8.0 g\u002Fdl is acceptable).\n5. Adequate hepatic function, defined as follows:\n\n   * Total bilirubin \\\u003C 2 x institutional ULN within 14 days prior to registration;\n   * AST or ALT \\\u003C 3 x institutional ULN within 14 days prior to registration.\n6. Adequate renal function, defined as GFR \\> 30 ml\u002Fmin or Cr \\\u003C 1.5.\n7. Negative serum pregnancy test within 2 weeks prior to registration for women of childbearing potential.\n8. Imaging prior to treatment including MRI of brain (with contrast preferred but not required).\n9. Ability to understand and the willingness to sign a written informed consent document.\n10. Inclusion #10 for Sub-study Only: Measurable disease per RANO criteria within 28 days of starting treatment on this study.\n\nExclusion Criteria\n\n1. Patients may not be receiving any other investigational agents.\n2. History of allergic reactions attributed to letrozole or other agents used in study.\n\n   Exclusion #2 for Sub-study Only: History of allergic reactions attributed to letrozole or TMZ.\n3. Uncontrolled intercurrent illness including, but not limited to, ongoing significant or serious active cardiovascular disease (CHF exacerbation, unstable angina or MI in last 6 months), or infection including the diagnosis of AIDS or active hepatitis B or C infection, or psychiatric illness or medical or personal conditions that in the opinion of the investigator would limit the patient's ability to participate.\n4. Patients attempting to conceive, and pregnant or nursing women are excluded from this study.","ALL","18 Years",{"count":77,"type":78},39,"ESTIMATED","INTERVENTIONAL",[81],"EARLY_PHASE1","The purpose of this study is to determine the ability of letrozole to penetrate the blood brain barrier and concentrate in gliomas.",[84],"Brain Tumor","2026-04-13",{"date":87,"type":88},"2026-04-16","ACTUAL",{"date":90,"type":88},"2017-05-16",{"date":92,"type":78},"2027-12",{"name":5,"class":6},1]