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
Institution CIUSSS DE L'ESTRIE – CENTRE HOSP. UNIV. DE SHERBROOKE
   HOPITAL FLEURIMONT
      3001 12e Avenue Nord, Sherbrooke, QC, J1H 5N4
Ville Sherbrooke
Investigateur(trice) principal(e) Dr David Fortin
Coordonnateur(trice) Marie-André 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