| Titre |
Phase III Randomized Trial of Post-Radiation Chemotherapy in Patients With Newly Diagnosed Ependymoma Ages 1 to 21 Years |
| Protocole ID |
ACNS0831 |
| ClinicalTrials.gov ID |
NCT01096368 |
| Type(s) de cancer |
Pédiatrique divers |
| Phase |
Phase III |
| Type étude |
Traitement |
| Médicament |
chimiothérapie de maintenance |
| Institution |
CENTRE UNIVERSITAIRE DE SANTE MCGILL
 HOPITAL DE MONTREAL POUR ENFANTS
1001 boul. Décarie , Montréal, QC, H4A 3J1
|
| Ville |
Montréal |
| Investigateur(trice) principal(e) |
Dre Sharon Abish
|
| Coordonnateur(trice) |
Katia Pamphile
514-412-4400 poste 22592
|
| Statut |
 Actif en recrutement |
| 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 |
|
Groupe d'étude en oncologie du Québec