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Study of Letrozole in Recurrent Gliomas

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03122197
Recruitment Status : Recruiting
First Posted : April 20, 2017
Last Update Posted : September 16, 2021
Sponsor:
Information provided by (Responsible Party):
Trisha Wise-Draper, University of Cincinnati

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

Condition or disease Intervention/treatment Phase
Brain Tumor Drug: Letrozole Oral Tablet Early Phase 1

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 42 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Basic Science
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
Actual Study Start Date : May 16, 2017
Estimated Primary Completion Date : June 2022
Estimated Study Completion Date : June 2023

Resource links provided by the National Library of Medicine

Drug Information available for: Letrozole

Arm Intervention/treatment
Experimental: Letrozole

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.

Drug: Letrozole Oral Tablet
Administration: Letrozole will be given orally once daily.
Other Name: Femara




Primary Outcome Measures :
  1. Overall Letrozole AUC in tumor tissue. [ Time Frame: 5 days ]
    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 :
  1. Adverse Events [ Time Frame: The time patients remain on treatment until 30 days after treatment completed ]
    The number of patients with treatment related toxicity will be assessed using CTCAE v4.0

  2. Progression free Survival [ Time Frame: From start of treatment until time of progression assessed up to 1 year ]
    Patients will be followed for response using RANO criteria to determine time from start of treatment to progression.

  3. Overall Survival [ Time Frame: From start of treatment until time of death assessed up to 1 year ]
    Patients will be followed from start of treatment until time of death



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Recurrent brain glioma with plan for resection or biopsy.
  • ECOG 0-2
  • Adequate labs

Exclusion Criteria:

  • Receiving other investigational agents.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03122197


Contacts
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Contact: UC Cancer Institute Clinical Trials Office 513-584-7698 cancer@uchealth.com

Locations
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United States, Ohio
University of Cincinnati Recruiting
Cincinnati, Ohio, United States, 45267
Contact: Trisha Wise-Draper, MD, PhD         
Sponsors and Collaborators
University of Cincinnati
Investigators
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Principal Investigator: Trisha Wise-Draper, MD University of Cincinnati
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Responsible Party: Trisha Wise-Draper, Principal Investigator, University of Cincinnati
ClinicalTrials.gov Identifier: NCT03122197    
Other Study ID Numbers: UCCI-BN-16-01
First Posted: April 20, 2017    Key Record Dates
Last Update Posted: September 16, 2021
Last Verified: September 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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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
Additional relevant MeSH terms:
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Brain Neoplasms
Neoplasms
Central Nervous System Neoplasms
Nervous System Neoplasms
Neoplasms by Site
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Letrozole
Antineoplastic Agents
Aromatase Inhibitors
Steroid Synthesis Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Estrogen Antagonists
Hormone Antagonists
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs