Clinical Trials /

Study of Letrozole in Recurrent Gliomas

NCT03122197

Description:

The purpose of this study is to determine the ability of letrozole to penetrate the blood brain barrier and concentrate in gliomas.

Related Conditions:
  • Glioma
Recruiting Status:

Recruiting

Phase:

Early Phase 1

Trial Eligibility

Document

Title

  • Brief Title: Study of Letrozole in Recurrent Gliomas
  • Official Title: A Phase 0/1 Exploratory Pharmacokinetic and Pharmacodynamics Study of Letrozole in Recurrent Gliomas

Clinical Trial IDs

  • ORG STUDY ID: UCCI-BN-16-01
  • NCT ID: NCT03122197

Conditions

  • Brain Tumor

Interventions

DrugSynonymsArms
Letrozole Oral TabletLetrozole

Purpose

The purpose of this study is to determine the ability of letrozole to penetrate the blood brain barrier and concentrate in gliomas.

Trial Arms

NameTypeDescriptionInterventions
LetrozoleExperimentalLetrozole doses range includes 2.5, 3, 6, 9, and 12 mg daily.
  • Letrozole Oral Tablet

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

October 25, 2019