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

 Neurological Cancer / Posted 3 weeks ago

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.

  • Inclusion Criteria :
    • 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 :
    • 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.
  • Study end date : 31/12/2021
  • Wales-Based Study Contact : Please speak to your clinician
  • Principal Investigator : Kartik Aysola. - kartik.aysola@orbustherapeutics.com
Contact details

University Hospitals Birmingham NHS Foundation Trust, Birmingham, United Kingdom, B15 2TH Sara Meade, MD 0121 3713589 Sara.Meade@uhb.nhs.uk # Edinburgh Cancer Centre - Western General Hospital. Edinburgh, United Kingdom, EH4 2XU Sara Erridge, MD +44( 0)131 537 3266 serridge@exseed.ed.ac.uk Contact: Magdalena Patrzalek 0131 537 3445 Magdalena.Patrzalek@nhslothian.scot.nhs.uk Guy's Hospital Recruiting London, United Kingdom, SE1 9RT Lucy Brazil, MD 020 7188 1447 lucy.brazil@gstt.nhs.uk Contact: Chris Bayliss 020 7188 7188 ext 51783 / 82018 Chris.Bayliss@gstt.nhs.uk The Royal Marsden NHS Foundation Trust London, United Kingdom, SW3 6JJ Contact: Liam Welsh, MD 020 8661 3300 Liam.Welsh@rmh.nhs.uk Contact: Kathy Greenwood 020 8661 3300 Kathy.Greenwood@rmh.nhs.uk The Christie NHS Foundation Trust Manchester, United Kingdom, M20 4BX Contact: Catherine McBain, MD 44 161 918 7008 catherine.mcbain@christie.nhs.uk Contact: Diane Catterall +44 (0)161 918 2358 diane.catterall2@nhs.net

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