| 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) |
Gabriele Riva
514-398-6907
|
| 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.
|
Groupe d'étude en oncologie du Québec