Study of Marizomib With Temozolomide and Radiotherapy in Patients With Newly Diagnosed Brain Cancer

PHASE1CompletedINTERVENTIONAL
Enrollment

66

Participants

Timeline

Start Date

August 17, 2016

Primary Completion Date

January 25, 2021

Study Completion Date

January 25, 2021

Conditions
GlioblastomaMalignant Glioma
Interventions
DRUG

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."

DRUG

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."

RADIATION

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.

DEVICE

Optune

Tumor Treating Fields Therapy device to be worn ≥ 18 hours per day.

Trial Locations (8)

8091

University of Zurich Hospital, Zurich

17033

Pennsylvania State University College of Medicine, Hershey

27710

Duke Cancer Center, Durham

60611

Northwestern Center For Clinical Research, Chicago

90404

John Wayne Cancer Center Outpatient Clinic, Santa Monica

92037

University of California San Diego Medical Center, La Jolla

92868

UC Irvine, Orange

M5G 2M9

Princess Margaret Cancer Centre, Toronto

Sponsors

Lead Sponsor

All Listed Sponsors
collaborator

Triphase Research and Development III Corp.

INDUSTRY

lead

Celgene

INDUSTRY