Clinical Studies Search

Protocol Summary


Protocol No.
PSCI-18-004
Prinicipal Investigator
McGregor, Lisa
Phase
Phase II
Age Group
Both
Scope
National
Secondary Protocol No.
ACNS1422
Title
A Phase 2 Study of Reduced Therapy for Newly Diagnosed Average-RiskWNT-Driven Medulloblastoma Patients
Objective
Primary Objective
To estimate the progression-free survival (PFS) of children ≥ 3 years of age with WNT-driven average-risk medulloblastoma using reduced craniospinal radiotherapy (CSI) (18 Gy) with a limited target volume boost to the tumor bed of 36 Gy for a total of 54 Gy and reduced chemotherapy approach (no vincristine during radiotherapy and reduced-dose maintenance chemotherapy) and to monitor the PFS for early evidence that the outcome is unacceptable.

Secondary Objectives
To prospectively test the hypothesis that DNA methylation profiling will accurately classify WNT-driven medulloblastoma.
To prospectively evaluate and longitudinally model the cognitive, social, emotional, behavioral and Quality of Life (QoL) functioning of children who are treated with reduced CSI (18 Gy) with a limited target volume boost to the tumor bed (to a total of 54 Gy) and reduced chemotherapy (reduced cisplatin, vincristine and CCNU).

Exploratory Objectives
To explore whether DNA methylation profiling of medulloblastoma samples will result in a predictive classification scheme for the Sonic Hedgehog (SHH), Group 3 and Group 4 medulloblastoma subgroups according to the Heidelberg classifier.
To describe the audiologic and endocrinologic toxicities, as well as peripheral neuropathy in children treated with reduced CSI (18 Gy) with a limited target volume boost to the tumor bed (to a total of 54 Gy) and reduced cisplatin and vincristine chemotherapy.
Applicable Disease Sites
Brain and Nervous System
Status
Open
Participating Institutions
Hershey Medical Center