| Titre |
A Phase 2 Study of Reduced Therapy for Newly Diagnosed Average-Risk WNT-Driven Medulloblastoma Patients |
| Protocole ID |
ACNS1422 |
| ClinicalTrials.gov ID |
NCT02724579 |
| Type(s) de cancer |
Pédiatrique divers |
| Phase |
Phase II |
| 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) |
Stephanie Badour
514-412-4400 poste 23807
|
| Statut |
 Actif en recrutement |
| Critètes d'éligibilité |
- Patients must be newly diagnosed and have a confirmed molecular diagnosis of classical histologic type (non large cell/anaplastic [LC/A]) WNT medulloblastoma from rapid central pathology screening review on APEC14B1 (immunohistochemistry [IHC]/molecular screening [positive nuclear beta (B)-catenin by IHC and positive for catenin beta 1 [CTNNB1] mutation) and confirmation of =< 1.5 cm^2 maximal cross-sectional area of residual tumor from rapid central imaging review
-
Patient must have negative lumbar cerebrospinal fluid (CSF) cytology; CSF cytology for staging should be performed preferably no sooner than 14 days post operatively to avoid false positive CSF; ideally, CSF should be obtained between day 14 and day 21 to allow for final staging status before enrollment onto the study
- Note: patients with positive CSF cytology obtained prior to 14 days after surgery may have cytology repeated to determine eligibility and final CSF status
-
Patients must have eligibility confirmed by rapid central imaging review on APEC14B1; standard whole brain magnetic resonance imaging (MRI) with and without contrast (gadolinium) and spine MRI with contrast (gadolinium) must be performed at the following time points:
- Pre-operative to include an MRI of the brain with and without contrast (including post-contrast three-dimensional [3D] T1-weighted image [T1WI] and post-contrast fluid-attenuated inversion recovery [FLAIR])
- Pre-operative spinal MRI with gadolinium; post-operative staging spinal MRI may be obtained if pre-operative imaging is not possible or is suboptimal; pre-operative spine imaging is strongly preferred, due to the potential of post-operative sequelae, which could affect metastasis detection
- Post-operative brain MRI within 72 hours of surgery
-
Patients must be enrolled on ALTE07C1 prior to enrollment on ACNS1422
- Patients must be enrolled within 36 days of definitive diagnostic surgery (day 0)
- Note: patients must begin treatment within 36 days of definitive surgery
- Patients must have no previous radiotherapy or chemotherapy other than corticosteroids
- Peripheral absolute neutrophil count (ANC) >= 1000/uL
- Platelet count >= 100,000/uL (transfusion independent)
- Hemoglobin >= 10.0 g/dL (may receive red blood cell [RBC] transfusions)
-
Creatinine clearance or radioisotope glomerular filtration rate (GFR) >= 70 mL/min/1.73 m^2 or a serum creatinine based on age/gender as follows:
- 3 to < 6 years of age: maximum (max) serum creatinine 0.8 mg/dL (males and females)
- 6 to < 10 years of age: max serum creatinine 1 mg/dL (males and females)
- 10 to < 13 years of age: max serum creatinine 1.2 mg/dL (males and females)
- 13 to < 16 years of age: max serum creatinine 1.5 md/dL (males) and 1.4 md/dL (females)
-
>= 16 years of age: max serum creatinine 1.7 mg/dL (males) and 1.4 mg/dL (females)
- The threshold creatinine values were derived from the Schwartz formula for estimating GFR utilizing child length and stature data published by the Centers for Disease Control and Prevention (CDC)
- Total or direct bilirubin =< 1.5 x upper limit of normal (ULN) for age, and
- Serum glutamate pyruvate (SGPT) (alanine aminotransferase [ALT]) =< 110 U/L (for the purpose of this study, the upper limit of normal [ULN] for SGPT is 45 U/L)
-
Central nervous system function defined as:
- Patients with seizure disorder may be enrolled if on anticonvulsants and well controlled
- Patients must not be in status epilepticus, a coma or on assisted ventilation at the time of study enrollment
- All patients and/or their parents or legal guardians must sign a written informed consent; assent, when appropriate, will be obtained according to institutional guidelines
- All institutional, Food and Drug Administration (FDA), and National Cancer Institute (NCI) requirements for human studies must be met
|
| Critètes d'exclusion |
- Patients with metastatic disease by either MRI evaluation (brain and spine) or lumbar CSF cytology are not eligible; patients who are unable to undergo a lumbar puncture for assessment of CSF cytology are ineligible
- Patients must not have received any prior tumor-directed therapy other than surgical intervention and corticosteroids
- Female patients who are pregnant are ineligible
- Lactating females are not eligible unless they have agreed not to breastfeed their infants
- Female patients of childbearing potential are not eligible unless a negative pregnancy test result has been obtained
- Sexually active patients of reproductive potential are not eligible unless they have agreed to use an effective contraceptive method for the duration of their study participation
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Groupe d'étude en oncologie du Québec