Recruiting
Early Phase 1

Letrozole

Sponsor:

University of Cincinnati

Code:

NCT03122197

Conditions

Brain Tumor

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Letrozole Oral Tablet

Temozolomide

Study Details

Brief summary:

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

Conditions

Brain Tumor

Study ID

NCT03122197

Start date

May 16, 2017

Status verified date

Apr, 2026

Completion date

Dec, 2027

Anticipated

Primary completion date

Sep 1, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

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;
  • Hemoglobin ≥ 8.0 g/dl (Note: The use of transfusion or other intervention to achieve Hgb ≥ 8.0 g/dl is acceptable).
5. 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.
6. Adequate renal function, defined as GFR > 30 ml/min or Cr < 1.5.
7. Negative serum pregnancy test within 2 weeks prior to registration for women of childbearing potential.
8. Imaging prior to treatment including MRI of brain (with contrast preferred but not required).
9. Ability to understand and the willingness to sign a written informed consent document.
10. Inclusion #10 for Sub-study Only: Measurable disease per RANO criteria within 28 days of starting treatment on this study.

Exclusion Criteria

1. Patients may not be receiving any other investigational agents.
2. 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.
3. 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.
4. Patients attempting to conceive, and pregnant or nursing women are excluded from this study.

Study Design

Enrollment

39 participants

Anticipated

Allocation

Non randomized

Intervention Model

Single group

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: Letrozole

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.

The 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 < 2/6 patients with DLTs. This dose will be planned for future phase II studies to determine potential efficacy.

experimental: Letrozole and temozolomide

Phase 1 expansion cohort of letrozole 15mg administered in combination with 50 mg/m2 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/m2 TMZ administered orally once daily.

experimental: 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/m2 TMZ in combination with dosing of 15 mg letrozole.

Interventions

Letrozole Oral Tablet

Administration: Letrozole will be given orally once daily.

Temozolomide

50 mg/m2 TMZ administered orally once daily

Primary outcome measure

  • Overall Letrozole AUC in tumor tissue. [ Time Frame: 5 days ]
  • Progression free survival in letrozole and temozolomide combination [ Time Frame: 6 months ]

Central Contacts and Locations

Central contacts

UC Cancer Center Clinical Trials Office

513-584-7698cancer@uchealth.com

Locations

University of Cincinnati

Recruiting

Cincinnati, Ohio, United States, 45267

More Information

Sponsor

University of Cincinnati

Last update posted

Aug 18, 2026

Last verified

Apr, 2026

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by University of Cincinnati on 2026-08-18.