Titre Phase III Randomized Trial of Post-Radiation Chemotherapy in Patients With Newly Diagnosed Ependymoma Ages 1 to 21 Years
Protocole ID COG-ACNS0831
ClinicalTrials.gov ID NCT01096368
Type(s) de cancer Pédiatrique divers
Phase Phase III
Type étude Traitement
Médicament chimiothérapie de maintenance
Institution CENTRE HOSPITALIER UNIVERSITAIRE SAINTE-JUSTINE
Ville Montréal
Investigateur(trice) principal(e) Dr Yvan Samson
Coordonnateur(trice) Linda Hershon
 514-345-4931 poste 5899
Statut Fermé
Critètes d'éligibilité 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
Critètes d'exclusion