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

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.