Letrozole for Brain Tumor

Recruiting in Palo Alto (17 mi)

Overseen byTrisha Wise-Draper, MD, PhD

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase < 1

Recruiting

Sponsor: University of Cincinnati

No Placebo Group

Approved in 3 Jurisdictions

Trial Summary

What is the purpose of this trial?

This trial is testing if letrozole can reach brain tumors and work with TMZ to treat patients with aggressive brain tumors. Letrozole helps by lowering hormone levels, and TMZ attacks the cancer cells' DNA.

Research Team

Trisha Wise-Draper, MD, PhD

Principal Investigator

University of Cincinnati

Eligibility Criteria

This trial is for individuals with recurrent brain gliomas who are scheduled for surgical removal or biopsy. Participants should be relatively active and self-caring (ECOG 0-2) and have satisfactory lab test results. Those currently on other experimental drugs cannot join.

Inclusion Criteria

I am older than 18 years.

I can take care of myself but might not be able to do heavy physical work.

My liver is functioning well according to recent tests.

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Exclusion Criteria

I am allergic to letrozole or similar medications used in this study.

I do not have any serious ongoing illnesses that would prevent me from participating.

Patients may not be receiving any other investigational agents

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Treatment Details

Interventions

Letrozole (Aromatase Inhibitor)

Trial OverviewThe study is testing the effectiveness of letrozole, an oral tablet, in reaching and concentrating within brain tumors when combined with temozolomide, a standard chemotherapy drug used to treat brain tumors.

Participant Groups

3Treatment groups

Experimental Treatment

Group I: Previously Received letrozole and temozolomideExperimental Treatment2 Interventions

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.

Group II: Letrozole and temozolomideExperimental Treatment2 Interventions

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.

Group III: LetrozoleExperimental Treatment1 Intervention

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.

Letrozole is already approved in Canada for the following indications:

Approved in Canada as Letrozole for:

Adjuvant treatment of postmenopausal women with hormone receptor-positive early breast cancer
First-line treatment of postmenopausal women with hormone receptor-positive advanced breast cancer