39 Participants NeededMy employer runs this trial

Letrozole for Brain Tumor

UC
UC
Overseen ByUC Cancer Center Clinical Trials Office
Age: 18+
Sex: Any
Trial Phase: Phase < 1
Sponsor: University of Cincinnati
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)
Approved in 3 JurisdictionsThis treatment is already approved in other countries

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests letrozole, a drug typically used for breast cancer, to determine if it can penetrate and remain in brain tumors called gliomas. The study consists of different parts: one examines letrozole alone, while another combines it with temozolomide to assess their combined effectiveness. It targets individuals diagnosed with a recurrent high-grade glioma who are planning surgery or a biopsy. Participants should not have severe heart issues or infections and must be free from other experimental treatments. As an Early Phase 1 trial, this research aims to understand how letrozole functions in people with gliomas, offering participants a chance to contribute to groundbreaking cancer research.

Do I have to stop taking my current medications for the trial?

The trial information does not specify if you need to stop taking your current medications. However, you cannot be on any other investigational drugs while participating.

Is there any evidence suggesting that this trial's treatments are likely to be safe?

Research has shown that letrozole is usually well-tolerated. Earlier studies found that taking up to 10 mg of letrozole daily and a single dose of 30 mg were safe. For this trial, doses up to 20 mg are expected to be safe based on previous research.

When combined with temozolomide, past studies have also shown letrozole to be safe. A daily dose of 15 mg of letrozole has been identified as safe for future studies. Temozolomide, a chemotherapy drug used to treat brain tumors, can have side effects. More serious side effects include low blood cell counts and tiredness, known risks of using temozolomide.

Overall, both letrozole alone and in combination with temozolomide have demonstrated a reasonable safety profile in earlier research.12345

Why are researchers excited about this trial's treatments?

Researchers are excited about letrozole for brain tumors because it offers a novel approach compared to standard treatments like surgery, radiation, and chemotherapy. Unlike other treatments for high-grade gliomas that primarily focus on killing cancer cells directly, letrozole works differently by targeting the production of estrogen, which can fuel the growth of certain tumors. Additionally, when combined with temozolomide, a chemotherapy drug, letrozole might enhance the effectiveness of the treatment by potentially disrupting tumor growth more effectively. This innovative combination could provide a new hope for patients with aggressive brain tumors, offering a potentially safer and more effective treatment option.

What evidence suggests that letrozole might be an effective treatment for brain tumors?

Research has shown that letrozole may help treat brain tumors like gliomas. Early tests found that letrozole can shrink tumors by more than 75% in just 8 days. It works by reducing the activity of aromatase, an enzyme that can help tumors grow. In this trial, one group of participants will receive letrozole alone, while another group will receive letrozole combined with temozolomide, another cancer drug. When used with temozolomide, letrozole has been shown to enhance treatment effectiveness by causing more damage to the cancer cells' DNA and improving outcomes. These findings suggest letrozole could be a strong option in fighting aggressive brain cancers.23567

Who Is on the Research Team?

LY

Lalanthica Yogendran, MD

Principal Investigator

University of Cincinnati

Are You a Good Fit for This Trial?

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.
See 7 more

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
See 2 more

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Letrozole 15mg administered orally once daily for a 7-day lead-in period, followed by combination with 50 mg/m2 temozolomide (TMZ) administered orally once daily

6 months
Weekly visits for the first month, then monthly

Follow-up

Participants are monitored for safety and effectiveness after treatment

1 year
Quarterly visits

Open-label extension (optional)

Participants may opt into continuation of treatment long-term

Long-term

What Are the Treatments Tested in This Trial?

Interventions

  • Letrozole

Trial Overview

The 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.

How Is the Trial Designed?

3

Treatment groups

Experimental Treatment

Group I: Previously Received letrozole and temozolomideExperimental Treatment2 Interventions
Group II: Letrozole and temozolomideExperimental Treatment2 Interventions
Group III: LetrozoleExperimental Treatment1 Intervention

Letrozole is already approved in United States, European Union, Canada for the following indications:

🇺🇸
Approved in United States as Femara for:
🇪🇺
Approved in European Union as Letrozole for:
🇨🇦
Approved in Canada as Letrozole for:

Find a Clinic Near You

Who Is Running the Clinical Trial?

University of Cincinnati

Lead Sponsor

Trials
442
Recruited
639,000+

Citations

Preclinical Pharmacological Evaluation of Letrozole as ... - PMC

Imaging analysis employing F18-FDG μPET/CT demonstrated a marked reduction of active tumor volume (>75%) after 8 days of letrozole treatment.

A Phase 0/I Pharmacokinetic and Pharmacodynamics and ...

High-grade gliomas (HGG) carry a poor prognosis, with glioblastoma accounting for almost 50% of primary brain malignancies in the elderly.

ucci-bn-16-01_protocol-v5_06jun2017-clean.docx

IHC analysis of the tumor before and after treatment with letrozole showed marked decrease in aromatase expression (Figure 5; A, positive ...

LETROZOLE TARGETS THE HUMAN ETHER-A-GO ... - PMC

Letrozole has demonstrated efficacy in pre-clinical GBM models. The objective of this research was to assess the potential for hERG inhibition by letrozole to ...

Preclinical Pharmacological Evaluation of Letrozole as a ...

Purpose High-grade gliomas (HGG) carry a poor prognosis, with glioblastoma accounting for almost 50% of primary brain malignancies in the elderly.

6.

pubmed.ncbi.nlm.nih.gov

pubmed.ncbi.nlm.nih.gov/38530160/

A Phase 0/I Pharmacokinetic and Pharmacodynamics and ...

We conducted a phase 0/I single-center clinical trial (NCT03122197) to assess the tumoral availability, pharmacokinetics (PK), safety, and tolerability of LTZ ...

A Phase 0/I Pharmacokinetic and Pharmacodynamics and ...

High-grade gliomas (HGG) carry a poor prognosis, with glioblastoma accounting for almost 50% of primary brain malignancies in the elderly.