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New treatment option for Brain Tumor
Official title Study of Letrozole in Recurrent Gliomas
ClinicalTrials.gov ID: NCT03122197
What this study is testing
What is Letrozole Oral Tablet?
Letrozole Oral Tablet is an investigational medicine, given as an once-daily pill taken by mouth, being studied as a potential treatment for brain tumor.
Also referred to as Femara.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- The purpose of this study is to determine the ability of letrozole to penetrate the blood brain barrier and concentrate in gliomas.
- Phase 1: an early, usually small safety study
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- Radiographically, histologically or cytologically confirmed recurrent brain high grade glioma with plan for resection or biopsy. \- Inclusion #1 for...
- 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;
You likely can't join 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...
- Uncontrolled intercurrent illness including, but not limited to, ongoing significant or serious active cardiovascular disease (CHF exacerbation...
- Patients attempting to conceive, and pregnant or nursing women are excluded from this study.
See the full eligibility 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...
- 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.
- 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...
- Patients attempting to conceive, and pregnant or nursing women are excluded from this study.
The study team makes the final eligibility decision.
Where it's taking place
- Cincinnati, Ohio, United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Cincinnati, Ohio, United States. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.