TITRE Essai randomisé de phase III de la chimiothérapie après une radiothérapie chez des patients de 1 à 21 ans atteints d’un épendymome qui vient d’être diagnostiqué
PROTOCOLE ID ACNS0831
CLINICAL TRIAL.gov ID NCT01096368
TYPE(S) DE CANCER Pédiatrique divers
PHASE Phase III
TYPE D'ÉTUDE Traitement
INSTITUTION CENTRE UNIVERSITAIRE DE SANTE MCGILL
1001 boul. Décarie
VILLE Montréal
INVESTIGATEUR(RICE) PRINCIPAL(E) Sharon Abish
COORDONATEUR(RICE) Katia Pamphile
mch.rho@muhc.mcgill.ca
514-412-4400 poste 22592
STATUT  Actif en recrutement
CRITÈRES D'ÉLIGIBILITÉ (EN)

DISEASE CHARACTERISTICS:

  • Histologically confirmed intracranial ependymoma meeting the following criteria:

    • Newly diagnosed disease
    • Classic ependymoma (WHO II) or anaplastic ependymoma (WHO III), including the following subtypes:

      • Clear cell
      • Papillary
      • Cellular
      • Combination of the above
  • No diagnosis of spinal cord ependymoma, myxopapillary ependymoma, subependymoma, ependymoblastoma, or mixed glioma
  • Has undergone surgical resection of the primary tumor

    • More than 1 attempted resection allowed
  • No metastatic disease by MRI or cerebrospinal fluid (CSF) cytology

    • CSR cytology from a ventriculostomy or permanent VP shunt that reveals the presence of tumor cells is indicative of metastatic disease
  • No evidence of non-contiguous spread beyond the primary site as determined by pre- or post-operative MRI of brain, pre- or post-operative MRI of the spine, and post-operative CSF cytology obtained from the lumbar CSF space

    • Lumbar CSF examination may be waived if deemed to be medically contraindicated

PATIENT CHARACTERISTICS:

  • ECOG performance status (PS) 0-2

    • Karnofsky PS for patients > 16 years of age
    • Lansky PS for patients ≤ 16 years of age
  • ANC ≥ 1,000/μL
  • Platelet count ≥ 100,000/μL (transfusion independent)
  • Creatinine clearance or radioisotope GFR ≥ 70 mL/min OR serum creatinine based on age/gender as follows:

    • 0.4 mg/dL (1 month to < 6 months of age)
    • 0.5 mg/dL (6 months to < 1 year of age)
    • 0.6 mg/dL (1 to 2 years of age)
    • 0.8 mg/dL (2 to < 6 years of age)
    • 1.0 mg/dL (6 to 10 years of age)
    • 1.2 mg/dL (10 to 13 years of age)
    • 1.5 mg/dL (male) or 1.4 mg/dL (female) (13 to < 16 years of age)
    • 1.7 mg/dL (male) or 1.4 mg/dL (female) (≥ 16 years of age)
  • Total bilirubin ≤ 1.5 times upper limit of normal (ULN) (≤ 3 times ULN for patients with Gilbert syndrome or hemolytic anemia)
  • AST or ALT < 3 times ULN
  • Adequate cardiac function defined as 1 of the following:

    • Shortening fraction ≥ 27% by ECHO
    • Ejection fraction ≥ 50% by gated radionuclide study.
  • Not pregnant or nursing

    • Patients who agree to stop nursing while on this study are allowed
  • Negative pregnancy test
  • Fertile patients must use effective contraception

PRIOR CONCURRENT THERAPY:

  • See Disease Characteristics
  • No prior treatment for ependymoma other than surgical intervention and corticosteroids
CRITÈRES D'EXCLUSION (EN)