Cerveau (SNC)

TITRE Une étude de phase II portant sur la chimioradiothérapie au carboplatine intra-artériel dans le traitement du glioblastome récidivant.
PROTOCOLE ID 2018-2452
CLINICAL TRIAL.gov ID NCT03672721
TYPE(S) DE CANCER Cerveau (SNC)
PHASE Phase II
TYPE D'ÉTUDE Traitement
INSTITUTION CIUSSS DE L'ESTRIE – CENTRE HOSP. UNIV. DE SHERBROOKE
3001 12e Avenue Nord
(819) 346-1110
VILLE Sherbrooke
INVESTIGATEUR(RICE) PRINCIPAL(E) David Fortin
COORDONATEUR(RICE) Marie-Andrée Roy
marie-andree.roy.s-inf.ciussse-chus@ssss.gouv.qc.ca
819-346-1110 poste 13895
STATUT  Actif en recrutement
CRITÈRES D'ÉLIGIBILITÉ (EN)
  • 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).
CRITÈRES D'EXCLUSION (EN)
  • 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