Study of Letrozole in Recurrent Gliomas

Recruiting now · Early Phase 1

Conditions studied: Brain Tumor

In brief

The purpose of this study is to determine the ability of letrozole to penetrate the blood brain barrier and concentrate in gliomas.

Key facts

Study ID

NCT03122197

Run by

University of Cincinnati

People needed

39

Starts

2017-05-16

Expected to finish

2027-12-01

Last updated by the study team

2026-04-16

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.
• Inclusion #10 for Sub-study Only: Measurable disease per RANO criteria within 28 days of starting treatment on this study.

You may not qualify if…

• 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 it is running

• University of Cincinnati — Cincinnati, Ohio, United States (enrolling)

Full record on ClinicalTrials.gov

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