NCT03122197 · University of Cincinnati
Study of Letrozole in Recurrent Gliomas
What this study is about
The purpose of this study is to determine the ability of letrozole to penetrate the blood brain barrier and concentrate in gliomas.
View original scientific description
The purpose of this study is to determine the ability of letrozole to penetrate the blood brain barrier and concentrate in gliomas.
Interventions
DRUG
Letrozole Oral Tablet
Administration: Letrozole will be given orally once daily.
DRUG
Temozolomide
50 mg/m2 TMZ administered orally once daily
Primary outcome measures
Overall Letrozole AUC in tumor tissue.
Time frame: 5 days
Pharmacokinetic modeling will be used to determine the overall AUC in the tumor tissue to assess for letrozole penetration through blood brain barrier.
Progression free survival in letrozole and temozolomide combination
Time frame: 6 months
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.
Who can participate
This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.
Inclusion criteria
- 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.
- Age \>18 years.
- ECOG performance status 0 -2 (Karnofsky \>60%, see Appendix A).
- 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;
- Hemoglobin ≥ 8.0 g/dl (Note: The use of transfusion or other intervention to achieve Hgb ≥ 8.0 g/dl is acceptable).
- Adequate hepatic function, defined as follows:
- Total bilirubin \< 2 x institutional ULN within 14 days prior to registration;
- AST or ALT \< 3 x institutional ULN within 14 days prior to registration.
- Adequate renal function, defined as GFR \> 30 ml/min or Cr \< 1.5.
- Negative serum pregnancy test within 2 weeks prior to registration for women of childbearing potential.
- Imaging prior to treatment including MRI of brain (with contrast preferred but not required).
- Ability to understand and the willingness to sign a written informed consent document.
Exclusion criteria
- Patients may not be receiving any other investigational agents.
- History of allergic reactions attributed to letrozole or other agents used in study. Exclusion #2 for Sub-study Only: History of allergic reactions attributed to letrozole or TMZ.
- 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.
- Patients attempting to conceive, and pregnant or nursing women are excluded from this study.
Where
- Cincinnati, Ohio
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Frequently asked questions
What is a clinical trial?
A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.
Is it safe to participate?
Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.
Will I be compensated?
Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.
Will I receive a placebo instead of treatment?
When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.
Can I leave a trial if I change my mind?
Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.
How long does a clinical trial last?
Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.
Data: ClinicalTrials.gov · synced Apr 16, 2026 · Source of record for eligibility and locations