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

Status: Active

Description

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.

Eligibility Criteria

Inclusion Criteria

  • Inclusion Criteria: Patients must meet all of the following inclusion criteria to be eligible for participation in this study: - Surgical or biopsy-proven diagnosis of WHO grade 3 AA. - First AA tumor progression or recurrence ≤ 6 months prior to randomization based on MRI using T2 hyperintesity, gadolinium (Gd)-contrast enhancement, or both. To avoid enrollment of patients with glioblastoma, patients with Gd-contrast enhancing tumors will be eligible if there is no necrosis seen on MRI and any of the following criteria is true: 1. Gd-contrast lesion margins are not clearly defined, 2. Gd-contrast lesions are only measurable in one dimension, 3. Gd-contrast lesion has two perpendicular diameters less than 10 mm, 4. Gd-contrast lesion has two perpendicular diameters greater than 10 mm but less than 20 mm and lesion does not demonstrate central necrosis, 5. Recent histopathological confirmation of WHO grade 3 AA - Received EBRT and temozolomide chemotherapy prior to first tumor progression or recurrence of WHO Grade 3 AA. - Completion of EBRT ≥ 6 months prior to randomization. - A patient whose AA tumor has progressed or recurred and has had another surgical resection prior to randomization will be eligible if a) pathology review confirms AA, and b) post-surgical MRI demonstrates measurable tumor on T2 FLAIR. - Karnofsky Performance Status (KPS) score of ≥ 70. Exclusion Criteria: Patients who meet any of the following exclusion criteria are not eligible for study participation: - MRI defining progression is consistent with a diagnosis of glioblastoma or radiation necrosis. - Patients who are considered to be refractory to EBRT and temozolomide but who have not progressed. - Prior systemic therapy for recurrence of AA. - Presence of extracranial or leptomeningeal disease. - Prior lomustine use. - Any other clinical condition or prior therapy that, in the opinion of the Investigator, would make the patient unsuitable for the study. - Pregnant or breastfeeding.

Locations & Contacts

Alabama

Birmingham
University of Alabama at Birmingham Cancer Center
Status: Active
Name Not Available

California

Los Angeles
UCLA / Jonsson Comprehensive Cancer Center
Status: Active
Name Not Available
USC / Norris Comprehensive Cancer Center
Status: Active
Name Not Available
Orange
UC Irvine Health / Chao Family Comprehensive Cancer Center
Status: Active
Name Not Available
San Diego
University of California San Diego
Status: Active
Name Not Available
San Francisco
UCSF Medical Center-Mount Zion
Status: Active
Name Not Available

Colorado

Aurora
University of Colorado Hospital
Status: Active
Name Not Available

Florida

Jacksonville
Mayo Clinic in Florida
Status: Active
Name Not Available
Tampa
Moffitt Cancer Center
Status: Active
Name Not Available

Georgia

Atlanta
Emory University Hospital / Winship Cancer Institute
Status: Active
Name Not Available

Illinois

Chicago
Northwestern University
Status: Active
Name Not Available

Iowa

Iowa City
University of Iowa / Holden Comprehensive Cancer Center
Status: Temporarily closed to accrual
Name Not Available

Kentucky

Lexington
University of Kentucky / Markey Cancer Center
Status: Active
Name Not Available

Massachusetts

Boston
Beth Israel Deaconess Medical Center
Status: Active
Name Not Available
Brigham and Women's Hospital
Status: Active
Name Not Available
Dana-Farber Cancer Institute
Status: Active
Name Not Available
Massachusetts General Hospital Cancer Center
Status: Active
Name Not Available

Minnesota

Rochester
Mayo Clinic
Status: Temporarily closed to accrual
Name Not Available

Missouri

Saint Louis
Siteman Cancer Center at Washington University
Status: Active
Name Not Available

North Carolina

Chapel Hill
UNC Lineberger Comprehensive Cancer Center
Status: Active
Name Not Available
Durham
Duke University Medical Center
Status: Active
Contact: Annick Desjardins
Phone: 888-275-3853
Email: desja002@mc.duke.edu
Winston-Salem
Wake Forest University Health Sciences
Status: Active
Name Not Available

Ohio

Cleveland
Case Comprehensive Cancer Center
Status: Temporarily closed to accrual
Name Not Available

Pennsylvania

Philadelphia
Thomas Jefferson University Hospital
Status: Active
Name Not Available
University of Pennsylvania / Abramson Cancer Center
Status: Active
Name Not Available

South Carolina

Charleston
Medical University of South Carolina
Status: Active
Name Not Available

Tennessee

Nashville
Vanderbilt University / Ingram Cancer Center
Status: Active
Name Not Available

Texas

Houston
M D Anderson Cancer Center
Status: Active
Name Not Available

Utah

Salt Lake City
Huntsman Cancer Institute / University of Utah
Status: Active
Contact: Howard Colman
Phone: 801-581-7200
Email: howard.colman@hci.utah.edu

Trial Objectives and Outline

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 340 patients will be randomized in a 1:1 ratio to receive either eflornithine + lomustine or lomustine alone.

Trial Phase & Type

Trial Phase

Phase III

Trial Type

Treatment

Lead Organization

Lead Organization
Orbus Therapeutics, Inc.

Trial IDs

Primary ID OT-15-001
Secondary IDs NCI-2016-01159
Clinicaltrials.gov ID NCT02796261