A Phase 2 Randomized Controlled Trial To Evaluate The Role Of Modified C.O.M.B.A.T MaintenanceRegimen in Children With High Risk Medulloblastoma

TMC Research Administration Council0 个研究点目标入组 0 人开始时间: 待定最近更新: 2021年11月24日

试验速览

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•High risk medulloblastoma as defined by
•anaplastic or large cell variant histology
•Molecular High risk subgroups (Group 3 or 4 disease) defined by presence of MYC
•amplification/MYC overexpression or CDK6 amplification
•-Leptomeningeal disease as evidenced on MRI of brain and spine at the time of diagnosis
•Cerebrospinal fluid cytology positivity for malignancy
•Metastatic disease involving the neuraxis
•Children should have achieved a CR or PR with standardtherapy defined as
•CR â?? complete clearing of radiographic disease for at least 4 weeks
•PR â?? >50% decrease in the sum of the products of all two dimensional masses for a minimum
•[4] Children must have normal organ and marrow function as defined below:
•Leukocyte count >3,000/mcL
•ANC >1,500/mcL
•Platelets >100,000/mcL
•Total bilirubin <2.0mg/dL
•AST/ALT <3 times upper limit of normal
•Creatinine clearance >60 mL/min/1.73 m2 as calculated by Shwartz estimate

•1] Children stratified as high risk purely by extent of residual disease post surgery
•[2] Relapsed or refractory medulloblastoma
•[3] History of allergic reactions attributed to compounds of similar chemical or biologic
•composition as that of the agents used in the study.
•[4] Parents unwilling to wait till therapy completion

发起方

TMC Research Administration Council