Clinical Trial Details
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NCT02796261 : Study to Evaluate Eflornithine + Lomustine vs Lomustine in Recurrent Anaplastic Astrocytoma (AA) Patients
PhasePhase 3
AgesMin: 18 Years Max: N/A
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.

- Unequivocal evidence of first AA tumor progression or recurrence = 3 months prior to
randomization based on MRI criteria for tumor progression using enlarging Gd-contrast
enhancement and/or T2 hyperintensity. Patients with non-measurable Gd contrast
enhancing tumors will only be eligible if there is no necrosis seen on MRI and/or
histopathological confirmation of AA per standard of care procedures is obtained.

- First tumor progression or recurrence following surgical resection or biopsy, if
resection is not feasible, EBRT and temozolomide chemotherapy.

- 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

- MRI defining progression is consistent with a diagnosis of glioblastoma or radiation

- Patients who are considered to be refractory to EBRT and temozolomide but who have not

- 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.
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