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 provides the rationale for initiation of a sub-study. A new sub-study "Letrozole and Temozolomide" expansion cohort has been opened to accrual. This Phase 1 expansion cohort of letrozole 15mg administered in combination with 50 mg/m2 metronomic temozolomide (TMZ) in patients with high grade gliomas. 19 subjects total (2 historical subjects from the main study and 17 new accruals) will be enrolled into this expansion cohort.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
39
Administration: Letrozole will be given orally once daily.
50 mg/m2 TMZ administered orally once daily
University of Cincinnati
Cincinnati, Ohio, United States
RECRUITINGOverall Letrozole AUC in tumor tissue.
Pharmacokinetic modeling will be used to determine the overall AUC in the tumor tissue to assess for letrozole penetration through blood brain barrier.
Time frame: 5 days
Progression free survival in letrozole and temozolomide combination
Sub-study expansion cohort only: Progression free survival using RANO criteria at 6 months from the start of the combination of 15 mg letrozole and 50 mg/m2 temozolomide.
Time frame: 6 months
Adverse Events
The number of patients with treatment related toxicity will be assessed using CTCAE v4.0
Time frame: The time patients remain on treatment until 30 days after treatment completed
Progression free Survival
Patients will be followed for response using RANO criteria to determine time from start of treatment to progression.
Time frame: From start of treatment until time of progression assessed up to 1 year
Overall Survival
Patients will be followed from start of treatment until time of death
Time frame: From start of treatment until time of death assessed up to 1 year
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