Last updated on March 2019

Study to Evaluate Eflornithine + Lomustine vs Lomustine in Recurrent Anaplastic Astrocytoma (AA) Patients

Brief description of study

The purpose of this study is to compare the efficacy and safety of eflornithine in combination with lomustine, compared to lomustine taken alone, in treating patients whose anaplastic astrocytoma has recurred/progressed after radiation and temozolomide chemotherapy.

Detailed Study Description

This study will consist of 4 study periods of up to 50 months in total, consisting of:

Screening Period - A maximum screening duration of 4 weeks.

Treatment Period - Treatment Arm A up to 24 months; Treatment Arm B up to 12 months.

End of Treatment Visit - A minimum of 4 weeks post last treatment for both arms.

Follow-Up Period - Up to 24 months.

A total of approximately 280 patients will be randomized in a 1:1 ratio to receive either eflornithine + lomustine or lomustine alone.

Clinical Study Identifier: NCT02796261

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Kaiser Permanente

Sacramento, CA United States
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Kaiser Permanente Center

Redwood City, CA United States
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Mayo Clinic Minnesota

Rochester, MN United States
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Washington University

Saint Louis, MO United States
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The University of Iowa

Iowa City, IA United States
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University of Utah

Salt Lake City, UT United States
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Swedish Health Services

Seattle, WA United States
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Vanderbilt University

Nashville, TN United States
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Ottawa Hospital

Ottawa, ON Canada
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Henry Ford Hospital

Detroit, MI United States
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Neuro-Oncology Associates

Dallas, TX United States
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MD Anderson Cancer Center

Houston, TX United States
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John Wayne Cancer Institute

Santa Monica, CA United States
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University of Pennsylvania

Philadelphia, PA United States
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UCSD Moores Cancer Center

San Diego, CA United States
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University of Colorado

Aurora, CO United States
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Hoag Memorial Hospital Presbyterian

Newport Beach, CA United States
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Waukesha Memorial Hospital

Waukesha, WI United States
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Northwestern University

Chicago, IL United States
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JFK Medical Center

Edison, NJ United States
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HCA Midwest Division

Kansas City, MO United States
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Kaiser Permanente

Los Angeles, CA United States
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Winship Cancer Institute

Atlanta, GA United States
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Dent Neurologic Institute

Buffalo, NY United States
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Mayo Clinic - Florida

Jacksonville, FL United States
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Recruitment Status: Open

Brief Description Eligibility Contact Research Team

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