Targeted Pediatric High-Grade Glioma Therapy
Start Date
8/2/2024
Completion Date
8/28/2034
Summary
The goal of this study is to perform genetic sequencing on brain tumors from children, adolescents, and young adult patients who have been newly diagnosed with a high-grade glioma. This molecular profiling will decide if patients are eligible to participate in a subsequent treatment-based clinical trial based on the genetic alterations identified in their tumor.
Detailed Description
A novel, molecularly-guided, multi-arm phase umbrella II trial is proposed in children, adolescents, and young adults with newly diagnosed HGG, including DIPG, in which we will (1) conduct comprehensive molecular screening of tumor tissue using a multi-omic approach (WES/WGS, gene fusion panels/RNASeq, DNA methylation microarray) across international CONNECT genomics cores with rapid return of clinical results, (2) stratify patients to biologically-targeted treatment arms, based on the tumor molecular profile and histopathology, and (3) perform longitudinal evaluation of peripheral blood, cerebrospinal fluid (CSF), and/or tumor tissue as well as advanced neuro-imaging to determine genomic, immune, and radiologic biomarkers predictive of response, recurrence, resistance, and toxicity. Based on results of the above tumor molecular profiling and pathology-based confirmation of HGG diagnosis, eligible patients will be assigned to one of several biologically guided treatment arms on a phase II trial. Approximately 300-350 patients will be enrolled on the screening protocol through which biospecimens (paired tumor DNA/RNA and normal comparator samples) will undergo extensive molecular profiling and/or there will be comprehensive central molecular and pathology review of previously obtained molecular results to assess eligibility to any of the therapeutic subprotocols of the phase II study.
Eligibility Criteria
Age Range: No minimum to 39 years
Conditions
Locations
Children's Hospital Colorado
Aurora, Colorado 80045
United States
Children's National Medical Center
Washington D.C., District of Columbia 20010
United States
Ann & Robert H. Lurie Children's Hospital of Chicago
Chicago, Illinois 60611
United States
Dana-Farber Cancer Institute
Boston, Massachusetts 02215
United States
C.S. Mott Children's Hospital
Ann Arbor, Michigan 48109
United States
Duke University Health System
Durham, North Carolina 27708
United States
Cincinnati Children's Hospital Medical Center
Cincinnati, Ohio 45229
United States
Nationwide Children's Hospital
Columbus, Ohio 43205
United States
Children's Hospital of Philadelphia
Philadelphia, Pennsylvania 19104
United States
Texas Children's Hospital
Houston, Texas 77030
United States
Seattle Children's Hospital
Seattle, Washington 98105
United States
Sydney Children's Hospital
Randwick, New South Wales 2031
Australia
Queensland Children's Hospital
South Brisbane, Queensland 4101
Australia
Royal Children's Hospital
Melbourne, Victoria 3052
Australia
Perth Children's Hospital
Perth, Western Australia 6000
Australia
The Hospital for Sick Children (SickKids)
Toronto, Ontario M5G1X8
Canada
Montreal Children's Hospital
Montreal, Quebec H4A3J1
Canada
Hopp Children's Cancer Center at NCT Heidelberg (KiTZ)
Heidelberg, Baden-Wurttemberg 69120
Germany
Princess Máxima Center
Utrecht, 3720
Netherlands
Starship Children's Hospital
Auckland, Grafton 1023
New Zealand
Great Ormond Street Hospital
London, WC1N 3JH
United Kingdom