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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. Identifier: NCT03122197
Recruitment Status : Recruiting
First Posted : April 20, 2017
Last Update Posted : October 1, 2018
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

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 12 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Basic Science
Official Title: A Phase 0/1 Exploratory Pharmacokinetic and Pharmacodynamics Study of Letrozole in Recurrent Gliomas
Actual Study Start Date : May 16, 2017
Estimated Primary Completion Date : April 2019
Estimated Study Completion Date : June 2019

Resource links provided by the National Library of Medicine

Drug Information available for: Letrozole

Arm Intervention/treatment
Experimental: Letrozole
Letrozole doses range includes 2.5, 3, 6, 9, and 12 mg daily.
Drug: Letrozole Oral Tablet
Daily treatment 1-5 days preop and resuming post op

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

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 identifier (NCT number): NCT03122197

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Contact: UC Cancer Institute Clinical Trials Office 513-584-7698

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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
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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 Identifier: NCT03122197     History of Changes
Other Study ID Numbers: UCCI-BN-16-01
First Posted: April 20, 2017    Key Record Dates
Last Update Posted: October 1, 2018
Last Verified: September 2018
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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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