Last updated on March 2020

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


Are you eligible to participate in this study?

You may be eligible for this study if you meet the following criteria:

  • Conditions: Recurrent Anaplastic Astrocytoma | Gliomas | Glioma | Astrocytoma
  • Age: Between 18 - 100 Years
  • Gender: Male or Female

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.

Recruitment Status: Open


Brief Description Eligibility Contact Research Team


Volunteer Sign-up

Sign up for our FREE service to receive email notifications when clinical trials are posted in the medical category of interest to you.