Description:
The purpose of this study is to determine the ability of letrozole to penetrate the blood
brain barrier and concentrate in gliomas.
Title
- 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
Clinical Trial IDs
- ORG STUDY ID:
UCCI-BN-16-01
- NCT ID:
NCT03122197
Conditions
Interventions
| Drug | Synonyms | Arms |
|---|
| Letrozole Oral Tablet | Femara | Letrozole |
Purpose
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.
Trial Arms
| Name | Type | Description | Interventions |
|---|
| Letrozole | Experimental | 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. | |
Eligibility Criteria
Inclusion Criteria:
- Recurrent brain glioma with plan for resection or biopsy.
- ECOG 0-2
- Adequate labs
Exclusion Criteria:
- Receiving other investigational agents.
| Maximum Eligible Age: | N/A |
| Minimum Eligible Age: | 18 Years |
| Eligible Gender: | All |
| Healthy Volunteers: | No |
Primary Outcome Measures
| Measure: | Overall Letrozole AUC in tumor tissue. |
| Time Frame: | 5 days |
| Safety Issue: | |
| Description: | 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
| Measure: | Adverse Events |
| Time Frame: | The time patients remain on treatment until 30 days after treatment completed |
| Safety Issue: | |
| Description: | The number of patients with treatment related toxicity will be assessed using CTCAE v4.0 |
| Measure: | Progression free Survival |
| Time Frame: | From start of treatment until time of progression assessed up to 1 year |
| Safety Issue: | |
| Description: | Patients will be followed for response using RANO criteria to determine time from start of treatment to progression. |
| Measure: | Overall Survival |
| Time Frame: | From start of treatment until time of death assessed up to 1 year |
| Safety Issue: | |
| Description: | Patients will be followed from start of treatment until time of death |
Details
| Phase: | Early Phase 1 |
| Primary Purpose: | Interventional |
| Overall Status: | Recruiting |
| Lead Sponsor: | University of Cincinnati |
Last Updated
December 11, 2020
