66
Participants
Start Date
August 17, 2016
Primary Completion Date
January 25, 2021
Study Completion Date
January 25, 2021
MRZ
"MRZ dose ranges from 0.55 to 1.2 mg/m2 given IV over 10 minutes on Days 1, 8, 15, 29, and 36 during Concomitant Treatment.~MRZ dose ranges from 0.55 to 1.2 mg/m2 given IV over 10 minutes on Days 1, 8, 15 every 28 days during Adjuvant Treatment.~IV hydration will be given prior to the MRZ infusion."
TMZ
"TMZ will be administered once daily, 7 days/week, for 6 weeks, starting on Day 1, at a dose of 75 mg/m2 during Concomitant Treatment.~TMZ will be administered once daily on Days 1-5 every cycle, dose range 150 to 200 mg/m2 during Adjuvant Treatment."
RT
Focal RT will be administered once daily, 5 days/week, for 30 doses over 6 weeks to a total dose of 60 Gy, starting on Day 1 during Concomitant Treatment.
Optune
Tumor Treating Fields Therapy device to be worn ≥ 18 hours per day.
University of Zurich Hospital, Zurich
Pennsylvania State University College of Medicine, Hershey
Duke Cancer Center, Durham
Northwestern Center For Clinical Research, Chicago
John Wayne Cancer Center Outpatient Clinic, Santa Monica
University of California San Diego Medical Center, La Jolla
UC Irvine, Orange
Princess Margaret Cancer Centre, Toronto
Lead Sponsor
Triphase Research and Development III Corp.
INDUSTRY
Celgene
INDUSTRY