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Aromatase Inhibitor
Letrozole for Brain Tumor
Phase < 1
Recruiting
Led By Trisha Wise-Draper, MD
Research Sponsored by University of Cincinnati
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Age >18 years
ECOG performance status 0 -2 (Karnofsky >60%)
Timeline
Screening 3 weeks
Treatment Varies
Follow Up from start of treatment until time of death assessed up to 1 year
Awards & highlights
Study Summary
This trial will test whether letrozole can help treat brain tumors by increasing the amount of the drug that gets to the tumor.
Who is the study for?
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.Check my eligibility
What is being tested?
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.See study design
What are the potential side effects?
Potential side effects may include fatigue, nausea, hair loss from temozolomide; and hot flashes, joint pain, and bone thinning from letrozole. Each person's reaction to these medications can vary.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I am older than 18 years.
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I can take care of myself but might not be able to do heavy physical work.
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My liver is functioning well according to recent tests.
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My brain tumor is confirmed to be high grade and plans are in place for surgery or biopsy.
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My kidney function is within the normal range.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ from start of treatment until time of death assessed up to 1 year
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~from start of treatment until time of death assessed up to 1 year
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Overall Letrozole AUC in tumor tissue.
Progression free survival in letrozole and temozolomide combination
Secondary outcome measures
Adverse Events
Overall Survival
Progression free Survival
Trial Design
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.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Temozolomide
2010
Completed Phase 3
~1930
Letrozole
FDA approved
Find a Location
Who is running the clinical trial?
University of CincinnatiLead Sponsor
428 Previous Clinical Trials
634,355 Total Patients Enrolled
Trisha Wise-Draper, MD3.02 ReviewsPrincipal Investigator - University of Cincinnati
University of Cincinnati
2 Previous Clinical Trials
59 Total Patients Enrolled
1Patient Review
I would strongly advise against seeing this physician. They were very cold and had a nasty attitude. I don't believe they knew what they were doing.
Trisha Wise-Draper, MD, PhD3.02 ReviewsPrincipal Investigator - University of Cincinnati
University of Cincinnati
4 Previous Clinical Trials
157 Total Patients Enrolled
1Patient Review
I would strongly advise against seeing this physician. They were very cold and had a nasty attitude. I don't believe they knew what they were doing.
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I am older than 18 years.I am allergic to letrozole or similar medications used in this study.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.I do not have any serious ongoing illnesses that would prevent me from participating.My brain tumor is confirmed to be high grade and plans are in place for surgery or biopsy.I am allergic to letrozole or TMZ.My kidney function is within the normal range.
Research Study Groups:
This trial has the following groups:- Group 1: Letrozole and temozolomide
- Group 2: Letrozole
- Group 3: Previously Received letrozole and temozolomide
Awards:
This trial has 3 awards, including:- Approved for 10 Other Conditions - This treatment demonstrated efficacy for 10 other conditions.
- All Individual Drugs Already Approved - Therapies where all constituent drugs have already been approved are likely to have better-understood side effect profiles.
- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
What is the target population size for this research project?
"This medical study is no longer seeking volunteers. The trial's first posting date was on May 16th, 2017 and the last update occurred on October 3rd, 2022. Currently there are 408 research projects with neoplasms as their focus area and 154 concerning Letrozole Oral Tablet still open for participants."
Answered by AI
In what health conditions is Letrozole Oral Tablet typically prescribed?
"Letrozole Oral Tablet is the preferred medication for treating breast-related ailments. This treatment can also be used to help those suffering from anovulatory cycle, tamoxifen, and postmenopause issues."
Answered by AI
Is there an ongoing call for participants in this trial?
"From the data provided by clinicaltrials.gov, it appears that this project is no longer enrolling patients since its last update on October 3rd 2022. However, there are presently 562 other trials actively recruiting for participation."
Answered by AI
Have any prior studies been conducted on Letrozole Oral Tablet?
"Currently, Letrozole Oral Tablet is being tested in 154 active clinical trials with 39 of them currently in the third phase. Trials for this medication can be found at 10968 sites worldwide; however, most are located near San Francisco, California."
Answered by AI
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