Back to resultsStudy of Letrozole in Recurrent Gliomas
Primary Purpose
Brain Tumor
Status
Active
Phase
Early Phase 1
Locations
United States
Study Type
Interventional
Intervention
Letrozole Oral Tablet
Sponsored by
About this trial
This is an interventional treatment trial for Brain Tumor
Eligibility Criteria
Inclusion Criteria:
- Recurrent brain glioma with plan for resection or biopsy.
- ECOG 0-2
- Adequate labs
Exclusion Criteria:
- Receiving other investigational agents.
Sites / Locations
- University of Cincinnati
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Letrozole
Arm Description
The 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.
Outcomes
Primary Outcome Measures
Overall Letrozole AUC in tumor tissue.
Pharmacokinetic modeling will be used to determine the overall AUC in the tumor tissue to assess for letrozole penetration through blood brain barrier.
Secondary Outcome Measures
Adverse Events
The number of patients with treatment related toxicity will be assessed using CTCAE v4.0
Progression free Survival
Patients will be followed for response using RANO criteria to determine time from start of treatment to progression.
Overall Survival
Patients will be followed from start of treatment until time of death
Full Information
NCT ID
NCT03122197
First Posted
April 10, 2017
Last Updated
October 24, 2023
Sponsor
University of Cincinnati
1. Study Identification
Unique Protocol Identification Number
NCT03122197
Brief Title
Study of Letrozole in Recurrent Gliomas
Official Title
A Phase 0/1 Pharmacokinetic and Pharmacodynamics and Safety and Tolerability Study of Letrozole in Combination With Standard Therapy in Recurrent High Grade Gliomas
Study Type
Interventional
2. Study Status
Record Verification Date
October 2023
Overall Recruitment Status
Active, not recruiting
Study Start Date
May 16, 2017 (Actual)
Primary Completion Date
September 1, 2024 (Anticipated)
Study Completion Date
December 2024 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Cincinnati
4. Oversight
Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
No
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
The purpose of this study is to determine the ability of letrozole to penetrate the blood brain barrier and concentrate in gliomas.
Detailed Description
Nine to forty-two (42 patients only if every cohort required expansion) total patients are planned for this phase 0/1 study to explore the ability of letrozole to penetrate the blood brain barrier and gliomas.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Brain Tumor
7. Study Design
Primary Purpose
Treatment
Study Phase
Early Phase 1
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
42 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Letrozole
Arm Type
Experimental
Arm Description
The 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.
Intervention Type
Drug
Intervention Name(s)
Letrozole Oral Tablet
Other Intervention Name(s)
Femara
Intervention Description
Administration: Letrozole will be given orally once daily.
Primary Outcome Measure Information:
Title
Overall Letrozole AUC in tumor tissue.
Description
Pharmacokinetic modeling will be used to determine the overall AUC in the tumor tissue to assess for letrozole penetration through blood brain barrier.
Time Frame
5 days
Secondary Outcome Measure Information:
Title
Adverse Events
Description
The number of patients with treatment related toxicity will be assessed using CTCAE v4.0
Time Frame
The time patients remain on treatment until 30 days after treatment completed
Title
Progression free Survival
Description
Patients will be followed for response using RANO criteria to determine time from start of treatment to progression.
Time Frame
From start of treatment until time of progression assessed up to 1 year
Title
Overall Survival
Description
Patients will be followed from start of treatment until time of death
Time Frame
From start of treatment until time of death assessed up to 1 year
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Recurrent brain glioma with plan for resection or biopsy.
ECOG 0-2
Adequate labs
Exclusion Criteria:
Receiving other investigational agents.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Trisha Wise-Draper, MD
Organizational Affiliation
University of Cincinnati
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Cincinnati
City
Cincinnati
State/Province
Ohio
ZIP/Postal Code
45267
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Study of Letrozole in Recurrent Gliomas
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