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.
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 approximately 36 months, or until patient death. A total of approximately 340 patients will be randomized in a 1:1 ratio to receive either eflornithine + lomustine or lomustine alone.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
343
Eflornithine 2.8 g/m2 administered orally every 8 hours on a 2 week on, 1 week off schedule
Lomustine 90 mg/m2 administered orally once every 6 weeks
Lomustine 110 mg/m2 administered orally once every 6 weeks
Overall survival
Time frame: 4 years
Progression-free survival (PFS)
Time frame: 4 years
Objective response rate (ORR)
Time frame: 4 years
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