Titre A Randomized Phase 3 Open-Label Study To Evaluate the Efficacy and Safety of Eflornithine With Lomustine Compared to Lomustine Alone in Patients With AA That Progress/Recur After Irradiation and Adjuvant Temozolomide Chemotherapy
Protocole ID Orbus OT-15-0011
ClinicalTrials.gov ID NCT02796261
Type(s) de cancer Cerveau (SNC)
Phase Phase III
Médicament Eflornithine + Lomustine
Institution CENTRE UNIVERSITAIRE DE SANTE MCGILL
   HOPITAL NEUROLOGIQUE DE MONTREAL
      3801 Rue Université, Montréal, QC, H3A 2B4
Ville Montréal
Investigateur(trice) principal(e) Dr Kevin Petrecca
Coordonnateur(trice) Isabelle Desloges
514-398-6183
Statut Actif en recrutement
Critètes d'éligibilité
  • 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.
Critètes d'exclusion
  • 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.