Titre A Phase II Study in Relapsing Glioblastoma of Intraarterial Concurrent Chemoradiation Therapy Using IA Carboplatin
Protocole ID 2018-2452
ClinicalTrials.gov ID NCT03672721
Type(s) de cancer Cerveau (SNC)
Phase Phase II
Stade Récidive
Type étude Traitement
Médicament Carboplatine
      3001 12e Avenue Nord, Sherbrooke, QC, J1H 5N4
Ville Sherbrooke
Investigateur(trice) principal(e) Dr David Fortin
Coordonnateur(trice) Marie-Andrée Roy
 819-346-1110 poste 13895
Statut Actif en recrutement
Critètes d'éligibilité
  • Histological diagnosis of glioblastoma multiforme
  • Radiological progression on an MRI scan, according to the RANO criteria, in the context of a known glioblastoma multiforme, already treated with the Stupp protocol of combined radiotherapy-Temozolomide, and progressing. This implies a measurable disease on MRI.
  • Prior radiotherapy and temozolomide, as per the Stupp protocol, no sooner than 4 weeks, is permitted.
  • 18 of age and over
  • Performance status: Karnofsky 60-100%
  • Haematopoietic parameters at enrolment:
  • Platelet counts > 100,000/mm^3
  • Hemoglobin > 8 g/dL
  • Absolute neutrophil count > 1,500/mm^3
  • No impaired bone marrow function
  • Hepatic parameters at enrolment:
  • Bilirubin ≤ 2 times normal value
  • AST and ALT ≤ 2 times upper limit of normal (ULN) Alkaline phosphatase ≤ 2 times ULN (unless attributed to tumor)
  • No impaired hepatic function
  • Renal parameters at enrollment:
  • No impaired renal function
  • Creatinine no greater than 1.5 fold of the normal value
  • Creatinine clearance > 30 ml/min.
  • Normal ECG
  • Written informed consent obtained
  • Patient should be either sterile or else use a contraceptive strategy (for at least 2 months prior to study accrual).
Critètes d'exclusion
  • Presence of a severe psychiatric or medical condition that would interfere with treatment administration or study enrolment.
  • Presence of an active auto-immune disease.
  • Occurrence of another malignancy within the past 5 years except curatively treated basal cell or squamous cell skin cancer or carcinoma in situ of the cervix
  • Pregnancy (as objectivated by a positive b-HCG) or actively nursing
  • Presence of an uncontrolled systemic infection