University of Cincinnati
The purpose of this study is to determine the ability of letrozole to penetrate the blood brain barrier and concentrate in gliomas.
Nine to forty-two (42 patients only if every cohort required expansion) total patients were planned for the main BN-16-01 phase 0/1 study to explore the ability of letrozole to penetrate the blood brain barrier and gliomas. As of November 2023 The BN-16-01 main study has completed active recruitment (20 subjects were accrued) and all safety and pharmacokinetics data have been analyzed with subsequent publications pending. Characterization of the safety and pharmacokinetics of letrozole in combination with standard of care treatments, such as TMZ has been completed for the main study and provid…
Inclusion Criteria 1. Radiographically, histologically or cytologically confirmed recurrent brain high grade glioma with plan for resection or biopsy. \- Inclusion #1 for Sub-study Only: Radiographically, histologically or cytologically confirmed recurrent brain high grade glioma. 2. Age \>18 years. 3. ECOG performance status 0 -2 (Karnofsky \>60%, see Appendix A). 4. CBC/differential obtained within 28 days prior to registration on study, with adequate bone marrow function defined as follows: * Absolute neutrophil count (ANC) ≥ 1,000 cells/mm3; * Platelets ≥ 100,000 cells/mm3;…
Administration: Letrozole will be given orally once daily.
50 mg/m2 TMZ administered orally once daily
Arctuva estimate
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