Testing the Addition of the Chemotherapy Drug Lomustine (Gleostine) to the Usual Treatment (Temozolomide and Radiation Therapy) for Newly Diagnosed MGMT Methylated Glioblastoma

May 15, 2026 updated by: NRG Oncology

A Phase III Trial of Lomustine-Temozolomide Combination Therapy Versus Standard Temozolomide in Patients With Methylated MGMT Promoter Glioblastoma

This phase III trial compares the effect of adding lomustine to standard chemotherapy with temozolomide and radiation therapy versus temozolomide and radiation therapy alone in shrinking or stabilizing newly diagnosed MGMT methylated glioblastoma. MGMT methylated tumors are more likely to respond to temozolomide chemotherapy. Temozolomide is in a class of medications called alkylating agents. It works by damaging the cell's DNA and may kill tumor cells and slow down or stop tumor growth. Lomustine is a chemotherapy drug and in a class of medications called alkylating agents. It damages the cell's DNA and may kill tumor cells. Radiation therapy uses high energy x-ray photons to kill tumor cells and shrink tumors. Adding lomustine to standard chemotherapy with temozolomide and radiation therapy may shrink or stabilize glioblastoma.

Study Overview

Status

Active, not recruiting

Conditions

Intervention / Treatment

Detailed Description

PRIMARY OBJECTIVE:

I. To determine if the regimen with the two alkylating agents temozolomide and lomustine with radiotherapy (RT) significantly prolongs overall survival (OS) versus (vs.) standard chemoradiotherapy with temozolomide in patients with newly diagnosed glioblastoma (GBM) with MGMT promoter methylation.

SECONDARY OBJECTIVES:

I. To determine if the regimen with the two alkylating agents temozolomide and lomustine with radiotherapy (RT) significantly prolongs progression-free survival (PFS) vs. standard chemoradiotherapy with temozolomide in patients with newly diagnosed GBM with MGMT promoter methylation.

II. To compare the two different chemotherapy regimens on patient-reported outcomes (PROs), as measured by the MD Anderson Symptom Inventory - Brain Tumor (MDASI-BT) in patients with newly diagnosed GBM with MGMT promoter methylation.

III. To determine if the regimen with the two alkylating agents temozolomide and lomustine with radiotherapy (RT) is associated with inferior short-term change in PROs as measured by MDASI-BT vs. standard chemoradiotherapy with temozolomide in patients with newly diagnosed GBM with MGMT promoter methylation.

IV. To assess toxicity in the two different chemotherapy regimens.

EXPLORATORY OBJECTIVES:

I. To assess the association between absolute lymphocyte counts and outcomes. II. To assess the association between CD4+ lymphocyte counts and outcomes. III. To compare the two different chemotherapy regimens in terms of long-term PROs as measured by MDASI-BT at years 1 and 2.

OUTLINE: Patients are randomized to 1 of 2 arms.

ARM I: Patients undergo radiation therapy 5 days per week and receive temozolomide orally (PO) once daily (QD) for 6 weeks in the absence of disease progression or unacceptable toxicity. Patients then receive temozolomide PO QD on days 1-5 of each cycle. Treatment repeats every 28 days for 6 cycles in the absence of disease progression or unacceptable toxicity. Patients also undergo magnetic resonance imaging (MRI) throughout the trial.

ARM II: Patients undergo radiation therapy 5 days per week for 6 weeks in the absence of disease progression or unacceptable toxicity. Patients also receive lomustine PO on day 1 of each cycle and temozolomide PO QD on days 2-6 of each cycle. Treatment repeats every 42 days for 6 cycles in the absence of disease progression or unacceptable toxicity. Patients also undergo MRI throughout the trial.

After completion of study treatment, patients are followed up every 3 months for year 1, every 4 months for year 2, and then every 6 months thereafter.

Study Type

Interventional

Enrollment (Actual)

265

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Canada
    • Quebec
      • Montreal, Quebec, Canada, H3H 2R9
        • The Research Institute of the McGill University Health Centre (MUHC)
      • Montreal, Quebec, Canada, H2X 3E4
        • CHUM - Centre hospitalier de l'Universite de Montreal
  • United States
    • Alaska
      • Fairbanks, Alaska, United States, 99701
        • Fairbanks Memorial Hospital
    • Arkansas
      • Fayetteville, Arkansas, United States, 72703
        • Highlands Oncology Group - Fayetteville
      • Little Rock, Arkansas, United States, 72205
        • University of Arkansas for Medical Sciences
      • Rogers, Arkansas, United States, 72758
        • Highlands Oncology Group - Rogers
      • Springdale, Arkansas, United States, 72762
        • Highlands Oncology Group
    • California
      • Anaheim, California, United States, 92806
        • Kaiser Permanente-Anaheim
      • Antioch, California, United States, 94531
        • Kaiser Permanente-Deer Valley Medical Center
      • Auburn, California, United States, 95602
        • Sutter Auburn Faith Hospital
      • Auburn, California, United States, 95603
        • Sutter Cancer Centers Radiation Oncology Services-Auburn
      • Bellflower, California, United States, 90706
        • Kaiser Permanente-Bellflower
      • Berkeley, California, United States, 94704
        • Alta Bates Summit Medical Center-Herrick Campus
      • Carmichael, California, United States, 95608
        • Mercy San Juan Medical Center
      • Carmichael, California, United States, 95608
        • Mercy Cancer Center - Carmichael
      • Concord, California, United States, 94520
        • John Muir Medical Center-Concord
      • Duarte, California, United States, 91010
        • City of Hope Comprehensive Cancer Center
      • Dublin, California, United States, 94568
        • Kaiser Permanente Dublin
      • Elk Grove, California, United States, 95758
        • Mercy Cancer Center - Elk Grove
      • Fremont, California, United States, 94538
        • Kaiser Permanente-Fremont
      • Fremont, California, United States, 94538
        • Palo Alto Medical Foundation-Fremont
      • Fresno, California, United States, 93720
        • Kaiser Permanente-Fresno
      • Fresno, California, United States, 93720
        • Fresno Cancer Center
      • Fresno, California, United States, 93720
        • Kaiser Permanente Fresno Orchard Plaza
      • Irvine, California, United States, 92612
        • UCI Health - Chao Family Comprehensive Cancer Center and Ambulatory Care
      • Los Angeles, California, United States, 90027
        • Kaiser Permanente Los Angeles Medical Center
      • Modesto, California, United States, 95356
        • Kaiser Permanente-Modesto
      • Modesto, California, United States, 95356
        • Kaiser Permanente- Modesto MOB II
      • Mountain View, California, United States, 94040
        • Palo Alto Medical Foundation-Camino Division
      • Oakland, California, United States, 94611
        • Kaiser Permanente-Oakland
      • Oakland, California, United States, 94611
        • Kaiser Permanente Oakland-Broadway
      • Ontario, California, United States, 91761
        • Kaiser Permanente-Ontario
      • Orange, California, United States, 92868
        • UC Irvine Health/Chao Family Comprehensive Cancer Center
      • Palo Alto, California, United States, 94301
        • Palo Alto Medical Foundation Health Care
      • Rancho Cordova, California, United States, 95670
        • Kaiser Permanente-Rancho Cordova Cancer Center
      • Redwood City, California, United States, 94063
        • Kaiser Permanente- Marshall Medical Offices
      • Richmond, California, United States, 94801
        • Kaiser Permanente-Richmond
      • Rocklin, California, United States, 95765
        • Mercy Cancer Center - Rocklin
      • Rohnert Park, California, United States, 94928
        • Rohnert Park Cancer Center
      • Roseville, California, United States, 95678
        • The Permanente Medical Group-Roseville Radiation Oncology
      • Roseville, California, United States, 95661
        • Kaiser Permanente-Roseville
      • Roseville, California, United States, 95661
        • Sutter Cancer Centers Radiation Oncology Services-Roseville
      • Roseville, California, United States, 95661
        • Sutter Roseville Medical Center
      • Sacramento, California, United States, 95816
        • Sutter Medical Center Sacramento
      • Sacramento, California, United States, 95814
        • Kaiser Permanente Downtown Commons
      • Sacramento, California, United States, 95823
        • Kaiser Permanente-South Sacramento
      • Sacramento, California, United States, 95823
        • South Sacramento Cancer Center
      • Sacramento, California, United States, 95816
        • Mercy Cancer Center - Sacramento
      • San Diego, California, United States, 92120
        • Kaiser Permanente-San Diego Zion
      • San Francisco, California, United States, 94115
        • Kaiser Permanente-San Francisco
      • San Francisco, California, United States, 94115
        • California Pacific Medical Center-Pacific Campus
      • San Jose, California, United States, 95119
        • Kaiser Permanente-Santa Teresa-San Jose
      • San Leandro, California, United States, 94577
        • Kaiser Permanente San Leandro
      • San Rafael, California, United States, 94903
        • Kaiser San Rafael-Gallinas
      • Santa Clara, California, United States, 95051
        • Kaiser Permanente Medical Center - Santa Clara
      • Santa Rosa, California, United States, 95403
        • Kaiser Permanente-Santa Rosa
      • Santa Rosa, California, United States, 95403
        • Sutter Pacific Medical Foundation
      • South San Francisco, California, United States, 94080
        • Kaiser Permanente Cancer Treatment Center
      • South San Francisco, California, United States, 94080
        • Kaiser Permanente-South San Francisco
      • Stockton, California, United States, 95210
        • Kaiser Permanente-Stockton
      • Sunnyvale, California, United States, 94086
        • Palo Alto Medical Foundation-Sunnyvale
      • Vacaville, California, United States, 95688
        • Kaiser Permanente Medical Center-Vacaville
      • Vallejo, California, United States, 94589
        • Kaiser Permanente-Vallejo
      • Walnut Creek, California, United States, 94596
        • Kaiser Permanente-Walnut Creek
      • Walnut Creek, California, United States, 94598
        • John Muir Medical Center-Walnut Creek
      • Woodland, California, United States, 95695
        • Woodland Memorial Hospital
    • Colorado
      • Colorado Springs, Colorado, United States, 80909
        • UCHealth Memorial Hospital Central
      • Colorado Springs, Colorado, United States, 80907
        • Rocky Mountain Cancer Centers-Penrose
      • Colorado Springs, Colorado, United States, 80920
        • Memorial Hospital North
      • Fort Collins, Colorado, United States, 80524
        • Poudre Valley Hospital
      • Fort Collins, Colorado, United States, 80528
        • Cancer Care and Hematology-Fort Collins
      • Golden, Colorado, United States, 80401
        • Lutheran Hospital - Cancer Centers of Colorado
      • Greeley, Colorado, United States, 80631
        • UCHealth Greeley Hospital
      • Littleton, Colorado, United States, 80122
        • AdventHealth Littleton
      • Loveland, Colorado, United States, 80538
        • Medical Center of the Rockies
      • Parker, Colorado, United States, 80138
        • AdventHealth Parker
    • Connecticut
      • Greenwich, Connecticut, United States, 06830
        • Smilow Cancer Hospital Care Center at Greenwich
      • New Haven, Connecticut, United States, 06520
        • Yale University
      • New Haven, Connecticut, United States, 06510
        • Smilow Cancer Center/Yale-New Haven Hospital
      • Trumbull, Connecticut, United States, 06611
        • Smilow Cancer Hospital Care Center-Trumbull
      • Waterford, Connecticut, United States, 06385
        • Smilow Cancer Hospital Care Center - Waterford
    • Florida
      • Jacksonville, Florida, United States, 32207
        • Baptist MD Anderson Cancer Center
      • Miami, Florida, United States, 33176
        • Miami Cancer Institute
    • Georgia
      • Atlanta, Georgia, United States, 30308
        • Emory University Hospital Midtown
      • Atlanta, Georgia, United States, 30322
        • Emory University Hospital/Winship Cancer Institute
      • Augusta, Georgia, United States, 30912
        • Augusta University Medical Center
      • Savannah, Georgia, United States, 31404
        • Memorial Health University Medical Center
    • Idaho
      • Boise, Idaho, United States, 83712
        • Saint Luke's Cancer Institute - Boise
      • Fruitland, Idaho, United States, 83619
        • Saint Luke's Cancer Institute - Fruitland
      • Meridian, Idaho, United States, 83642
        • Saint Luke's Cancer Institute - Meridian
      • Nampa, Idaho, United States, 83687
        • Saint Luke's Cancer Institute - Nampa
      • Twin Falls, Idaho, United States, 83301
        • Saint Luke's Cancer Institute - Twin Falls
    • Illinois
      • Alton, Illinois, United States, 62002
        • Alton Memorial Hospital
      • Aurora, Illinois, United States, 60504
        • Rush-Copley Medical Center
      • Aurora, Illinois, United States, 60506
        • Advocate Outpatient Center - Aurora
      • Barrington, Illinois, United States, 60010
        • Advocate Good Shepherd Hospital
      • Bloomington, Illinois, United States, 61704
        • Illinois CancerCare-Bloomington
      • Canton, Illinois, United States, 61520
        • Illinois CancerCare-Canton
      • Carthage, Illinois, United States, 62321
        • Illinois CancerCare-Carthage
      • Centralia, Illinois, United States, 62801
        • Centralia Oncology Clinic
      • Chicago, Illinois, United States, 60637
        • University of Chicago Comprehensive Cancer Center
      • Chicago, Illinois, United States, 60612
        • University of Illinois
      • Chicago, Illinois, United States, 60657
        • Advocate Illinois Masonic Medical Center
      • Chicago, Illinois, United States, 60612
        • Rush MD Anderson Cancer Center
      • Crystal Lake, Illinois, United States, 60014
        • AMG Crystal Lake - Oncology
      • Danville, Illinois, United States, 61832
        • Carle at The Riverfront
      • Decatur, Illinois, United States, 62526
        • Decatur Memorial Hospital
      • Decatur, Illinois, United States, 62526
        • Cancer Care Specialists of Illinois - Decatur
      • Downers Grove, Illinois, United States, 60515
        • Advocate Good Samaritan Hospital
      • Effingham, Illinois, United States, 62401
        • Crossroads Cancer Center
      • Effingham, Illinois, United States, 62401
        • Carle Physician Group-Effingham
      • Elgin, Illinois, United States, 60123
        • Advocate Sherman Hospital
      • Eureka, Illinois, United States, 61530
        • Illinois CancerCare-Eureka
      • Galesburg, Illinois, United States, 61401
        • Illinois CancerCare-Galesburg
      • Hazel Crest, Illinois, United States, 60429
        • Advocate South Suburban Hospital
      • Kewanee, Illinois, United States, 61443
        • Illinois CancerCare-Kewanee Clinic
      • Libertyville, Illinois, United States, 60048
        • AMG Libertyville - Oncology
      • Macomb, Illinois, United States, 61455
        • Illinois CancerCare-Macomb
      • Mattoon, Illinois, United States, 61938
        • Carle Physician Group-Mattoon/Charleston
      • New Lenox, Illinois, United States, 60451
        • UC Comprehensive Cancer Center at Silver Cross
      • O'Fallon, Illinois, United States, 62269
        • Cancer Care Center of O'Fallon
      • O'Fallon, Illinois, United States, 62269
        • HSHS Saint Elizabeth's Hospital
      • Oak Lawn, Illinois, United States, 60453-2699
        • Advocate Christ Medical Center
      • Orland Park, Illinois, United States, 60462
        • University of Chicago Medicine-Orland Park
      • Ottawa, Illinois, United States, 61350
        • Illinois CancerCare-Ottawa Clinic
      • Park Ridge, Illinois, United States, 60068
        • Advocate Lutheran General Hospital
      • Pekin, Illinois, United States, 61554
        • Illinois CancerCare-Pekin
      • Peoria, Illinois, United States, 61637
        • OSF Saint Francis Medical Center
      • Peoria, Illinois, United States, 61615
        • Illinois CancerCare-Peoria
      • Peru, Illinois, United States, 61354
        • Illinois CancerCare-Peru
      • Princeton, Illinois, United States, 61356
        • Illinois CancerCare-Princeton
      • Shiloh, Illinois, United States, 62269
        • Memorial Hospital East
      • Springfield, Illinois, United States, 62702
        • Southern Illinois University School of Medicine
      • Springfield, Illinois, United States, 62702
        • Springfield Clinic
      • Springfield, Illinois, United States, 62781
        • Springfield Memorial Hospital
      • Urbana, Illinois, United States, 61801
        • Carle Cancer Center
      • Urbana, Illinois, United States, 61801
        • The Carle Foundation Hospital
      • Washington, Illinois, United States, 61571
        • Illinois CancerCare - Washington
      • Zion, Illinois, United States, 60099
        • Midwestern Regional Medical Center
    • Indiana
      • Crown Point, Indiana, United States, 46307
        • Northwest Cancer Center - Main Campus
      • Crown Point, Indiana, United States, 46307
        • UChicago Medicine Northwest Indiana
      • Dyer, Indiana, United States, 46311
        • Northwest Oncology LLC
      • Hobart, Indiana, United States, 46342
        • Northwest Cancer Center - Hobart
      • Hobart, Indiana, United States, 46342
        • Saint Mary Medical Center
      • Indianapolis, Indiana, United States, 46219
        • Community Cancer Center East
      • Indianapolis, Indiana, United States, 46227
        • Community Cancer Center South
      • Indianapolis, Indiana, United States, 46256
        • Community Cancer Center North
      • Munster, Indiana, United States, 46321
        • The Community Hospital
      • Munster, Indiana, United States, 46321
        • Women's Diagnostic Center - Munster
      • Valparaiso, Indiana, United States, 46383
        • Northwest Cancer Center - Valparaiso
    • Iowa
      • Ames, Iowa, United States, 50010
        • Mary Greeley Medical Center
      • Ames, Iowa, United States, 50010
        • McFarland Clinic - Ames
      • Ankeny, Iowa, United States, 50023
        • UI Health Care Mission Cancer and Blood - Ankeny Clinic
      • Cedar Rapids, Iowa, United States, 52403
        • Mercy Hospital
      • Cedar Rapids, Iowa, United States, 52403
        • Oncology Associates at Mercy Medical Center
      • Clive, Iowa, United States, 50325
        • Mercy Cancer Center-West Lakes
      • Clive, Iowa, United States, 50325
        • UI Health Care Mission Cancer and Blood - West Des Moines Clinic
      • Creston, Iowa, United States, 50801
        • Greater Regional Medical Center
      • Des Moines, Iowa, United States, 50309
        • Iowa Methodist Medical Center
      • Des Moines, Iowa, United States, 50314
        • Mercy Medical Center - Des Moines
      • Des Moines, Iowa, United States, 50314
        • Broadlawns Medical Center
      • Des Moines, Iowa, United States, 50309
        • UI Health Care Mission Cancer and Blood - Des Moines Clinic
      • Des Moines, Iowa, United States, 50314
        • UI Health Care Mission Cancer and Blood - Laurel Clinic
      • Sioux City, Iowa, United States, 51101
        • Siouxland Regional Cancer Center
      • Waukee, Iowa, United States, 50263
        • UI Health Care Mission Cancer and Blood - Waukee Clinic
      • West Des Moines, Iowa, United States, 50266
        • Mercy Medical Center-West Lakes
      • West Des Moines, Iowa, United States, 50266
        • The Iowa Clinic PC
    • Kansas
      • Kansas City, Kansas, United States, 66160
        • University of Kansas Cancer Center
      • Overland Park, Kansas, United States, 66210
        • University of Kansas Cancer Center-Overland Park
      • Overland Park, Kansas, United States, 66211
        • University of Kansas Hospital-Indian Creek Campus
      • Westwood, Kansas, United States, 66205
        • University of Kansas Hospital-Westwood Cancer Center
      • Wichita, Kansas, United States, 67214
        • Ascension Via Christi Hospitals Wichita
    • Kentucky
      • Lexington, Kentucky, United States, 40536
        • University of Kentucky/Markey Cancer Center
      • Louisville, Kentucky, United States, 40202
        • The James Graham Brown Cancer Center at University of Louisville
      • Louisville, Kentucky, United States, 40241
        • Norton Brownsboro Hospital and Medical Campus
      • Louisville, Kentucky, United States, 40245
        • UofL Health Medical Center Northeast
    • Maine
      • Brewer, Maine, United States, 04412
        • Lafayette Family Cancer Center-EMMC
    • Maryland
      • Baltimore, Maryland, United States, 21201
        • University of Maryland/Greenebaum Cancer Center
      • Columbia, Maryland, United States, 21044
        • Central Maryland Radiation Oncology in Howard County
      • Glen Burnie, Maryland, United States, 21061
        • UM Baltimore Washington Medical Center/Tate Cancer Center
      • Largo, Maryland, United States, 20774
        • UM Capital Region Medical Center
    • Michigan
      • Ann Arbor, Michigan, United States, 48106
        • Trinity Health Saint Joseph Mercy Hospital Ann Arbor
      • Brighton, Michigan, United States, 48114
        • Trinity Health IHA Medical Group Hematology Oncology - Brighton
      • Brighton, Michigan, United States, 48114
        • Trinity Health Medical Center - Brighton
      • Canton, Michigan, United States, 48188
        • Trinity Health IHA Medical Group Hematology Oncology - Canton
      • Canton, Michigan, United States, 48188
        • Trinity Health Medical Center - Canton
      • Caro, Michigan, United States, 48723
        • Caro Cancer Center
      • Chelsea, Michigan, United States, 48118
        • Trinity Health IHA Medical Group Hematology Oncology - Chelsea Hospital
      • Chelsea, Michigan, United States, 48118
        • Chelsea Hospital
      • Detroit, Michigan, United States, 48236
        • Henry Ford Health Saint John Hospital
      • Grand Rapids, Michigan, United States, 49503
        • Trinity Health Grand Rapids Hospital
      • Grand Rapids, Michigan, United States, 49503
        • Corewell Health Grand Rapids Hospitals - Butterworth Hospital
      • Grand Rapids, Michigan, United States, 49503
        • Corewell Health Grand Rapids Hospitals - Helen DeVos Children's Hospital
      • Grosse Pointe Woods, Michigan, United States, 48236
        • Henry Ford Saint John Hospital - Van Elslander
      • Kalamazoo, Michigan, United States, 49007
        • West Michigan Cancer Center
      • Kalamazoo, Michigan, United States, 49007
        • Bronson Methodist Hospital
      • Kalamazoo, Michigan, United States, 49048
        • Beacon Kalamazoo
      • Lansing, Michigan, United States, 48912
        • University of Michigan Health - Sparrow Lansing
      • Livonia, Michigan, United States, 48154
        • Trinity Health Saint Mary Mercy Livonia Hospital
      • Macomb, Michigan, United States, 48044
        • Henry Ford Saint John Hospital - Macomb Medical
      • Marlette, Michigan, United States, 48453
        • Saint Mary's Oncology/Hematology Associates of Marlette
      • Pontiac, Michigan, United States, 48341
        • Trinity Health Saint Joseph Mercy Oakland Hospital
      • Pontiac, Michigan, United States, 48341
        • Michigan Healthcare Professionals Pontiac
      • Saginaw, Michigan, United States, 48604
        • Oncology Hematology Associates of Saginaw Valley PC
      • Saginaw, Michigan, United States, 48601
        • MyMichigan Medical Center Saginaw
      • Tawas City, Michigan, United States, 48764
        • MyMichigan Medical Center Tawas
      • Warren, Michigan, United States, 48093
        • Henry Ford Health Warren Hospital
      • West Branch, Michigan, United States, 48661
        • Saint Mary's Oncology/Hematology Associates of West Branch
      • Wyoming, Michigan, United States, 49519
        • University of Michigan Health - West
      • Ypsilanti, Michigan, United States, 48197
        • Trinity Health IHA Medical Group Hematology Oncology Ann Arbor Campus
    • Minnesota
      • Bemidji, Minnesota, United States, 56601
        • Sanford Joe Lueken Cancer Center
      • Brainerd, Minnesota, United States, 56401
        • Essentia Health Saint Joseph's Medical Center
      • Burnsville, Minnesota, United States, 55337
        • Fairview Ridges Hospital
      • Burnsville, Minnesota, United States, 55337
        • Minnesota Oncology - Burnsville
      • Coon Rapids, Minnesota, United States, 55433
        • Mercy Hospital
      • Deer River, Minnesota, United States, 56636
        • Essentia Health - Deer River Clinic
      • Duluth, Minnesota, United States, 55805
        • Essentia Health Cancer Center
      • Duluth, Minnesota, United States, 55805
        • Essentia Health Saint Mary's Medical Center
      • Duluth, Minnesota, United States, 55805
        • Miller-Dwan Hospital
      • Edina, Minnesota, United States, 55435
        • Fairview Southdale Hospital
      • Fridley, Minnesota, United States, 55432
        • Unity Hospital
      • Hibbing, Minnesota, United States, 55746
        • Essentia Health Hibbing Clinic
      • Maple Grove, Minnesota, United States, 55369
        • Fairview Clinics and Surgery Center Maple Grove
      • Maplewood, Minnesota, United States, 55109
        • Saint John's Hospital - Healtheast
      • Maplewood, Minnesota, United States, 55109
        • Minnesota Oncology Hematology PA-Maplewood
      • Marshall, Minnesota, United States, 56258
        • Avera Cancer Institute at Marshall
      • Minneapolis, Minnesota, United States, 55415
        • Hennepin County Medical Center
      • Minneapolis, Minnesota, United States, 55407
        • Abbott-Northwestern Hospital
      • Minneapolis, Minnesota, United States, 55454
        • Health Partners Inc
      • Monticello, Minnesota, United States, 55362
        • Monticello Cancer Center
      • Robbinsdale, Minnesota, United States, 55422
        • North Memorial Medical Health Center
      • Saint Cloud, Minnesota, United States, 56303
        • Coborn Cancer Center at Saint Cloud Hospital
      • Saint Louis Park, Minnesota, United States, 55416
        • Park Nicollet Clinic - Saint Louis Park
      • Saint Paul, Minnesota, United States, 55101
        • Regions Hospital
      • Saint Paul, Minnesota, United States, 55102
        • United Hospital
      • Sandstone, Minnesota, United States, 55072
        • Essentia Health Sandstone
      • Stillwater, Minnesota, United States, 55082
        • Lakeview Hospital
      • Virginia, Minnesota, United States, 55792
        • Essentia Health Virginia Clinic
      • Waconia, Minnesota, United States, 55387
        • Ridgeview Medical Center
    • Missouri
      • Cape Girardeau, Missouri, United States, 63703
        • Saint Francis Medical Center
      • City of Saint Peters, Missouri, United States, 63376
        • Siteman Cancer Center at Saint Peters Hospital
      • Creve Coeur, Missouri, United States, 63141
        • Siteman Cancer Center at West County Hospital
      • Farmington, Missouri, United States, 63640
        • Parkland Health Center - Farmington
      • Kansas City, Missouri, United States, 64154
        • University of Kansas Cancer Center - North
      • Kansas City, Missouri, United States, 64132
        • Research Medical Center
      • Lee's Summit, Missouri, United States, 64064
        • University of Kansas Cancer Center - Lee's Summit
      • North Kansas City, Missouri, United States, 64116
        • University of Kansas Cancer Center at North Kansas City Hospital
      • Sainte Genevieve, Missouri, United States, 63670
        • Sainte Genevieve County Memorial Hospital
      • Springfield, Missouri, United States, 65804
        • Mercy Hospital Springfield
      • St Louis, Missouri, United States, 63110
        • Washington University School of Medicine
      • St Louis, Missouri, United States, 63129
        • Siteman Cancer Center-South County
      • St Louis, Missouri, United States, 63136
        • Siteman Cancer Center at Christian Hospital
      • St Louis, Missouri, United States, 63131
        • Missouri Baptist Medical Center
      • St Louis, Missouri, United States, 63141
        • Mercy Hospital Saint Louis
      • Sullivan, Missouri, United States, 63080
        • Missouri Baptist Sullivan Hospital
      • Sunset Hills, Missouri, United States, 63127
        • BJC Outpatient Center at Sunset Hills
    • Montana
      • Billings, Montana, United States, 59101
        • Billings Clinic Cancer Center
      • Bozeman, Montana, United States, 59715
        • Bozeman Health Deaconess Hospital
    • Nevada
      • Reno, Nevada, United States, 89502
        • Renown Regional Medical Center
    • New Hampshire
      • Lebanon, New Hampshire, United States, 03756
        • Dartmouth Hitchcock Medical Center/Dartmouth Cancer Center
    • New Jersey
      • Edison, New Jersey, United States, 08818
        • John F Kennedy Medical Center
      • Englewood, New Jersey, United States, 07631
        • Englewood Hospital and Medical Center
      • Jersey City, New Jersey, United States, 07302
        • Jersey City Medical Center
      • Livingston, New Jersey, United States, 07039
        • Saint Barnabas Medical Center
      • Long Branch, New Jersey, United States, 07740
        • Monmouth Medical Center
      • Neptune City, New Jersey, United States, 07753
        • Jersey Shore Medical Center
      • New Brunswick, New Jersey, United States, 08903
        • Rutgers Cancer Institute of New Jersey
      • Newark, New Jersey, United States, 07101
        • Rutgers New Jersey Medical School
      • Toms River, New Jersey, United States, 08755
        • Community Medical Center
    • New Mexico
      • Albuquerque, New Mexico, United States, 87106
        • University of New Mexico Cancer Center
    • New York
      • Canandaigua, New York, United States, 14424
        • Sands Cancer Center
      • Dansville, New York, United States, 14437
        • Noyes Memorial Hospital/Myers Cancer Center
      • Lake Success, New York, United States, 11042
        • Northwell Health/Center for Advanced Medicine
      • New York, New York, United States, 10032
        • NYP/Columbia University Medical Center/Herbert Irving Comprehensive Cancer Center
      • Rochester, New York, United States, 14642
        • University of Rochester
      • Syracuse, New York, United States, 13210
        • State University of New York Upstate Medical University
    • North Carolina
      • Chapel Hill, North Carolina, United States, 27599
        • UNC Lineberger Comprehensive Cancer Center
    • North Dakota
      • Bismarck, North Dakota, United States, 58501
        • Sanford Bismarck Medical Center
      • Fargo, North Dakota, United States, 58122
        • Sanford Roger Maris Cancer Center
      • Fargo, North Dakota, United States, 58122
        • Sanford Broadway Medical Center
    • Ohio
      • Akron, Ohio, United States, 44307
        • Cleveland Clinic Akron General
      • Beavercreek, Ohio, United States, 45431
        • Indu and Raj Soin Medical Center
      • Centerville, Ohio, United States, 45459
        • Miami Valley Hospital South
      • Centerville, Ohio, United States, 45459
        • Dayton Physicians LLC-Miami Valley South
      • Chillicothe, Ohio, United States, 45601
        • Adena Regional Medical Center
      • Cincinnati, Ohio, United States, 45219
        • University of Cincinnati Cancer Center-UC Medical Center
      • Cincinnati, Ohio, United States, 45220
        • Good Samaritan Hospital - Cincinnati
      • Cincinnati, Ohio, United States, 45242
        • Bethesda North Hospital
      • Cleveland, Ohio, United States, 44109
        • MetroHealth Medical Center
      • Cleveland, Ohio, United States, 44195
        • Cleveland Clinic Foundation
      • Columbus, Ohio, United States, 43214
        • Riverside Methodist Hospital
      • Columbus, Ohio, United States, 43210
        • Ohio State University Comprehensive Cancer Center
      • Dayton, Ohio, United States, 45409
        • Miami Valley Hospital
      • Dayton, Ohio, United States, 45415
        • Miami Valley Hospital North
      • Dayton, Ohio, United States, 45415
        • Dayton Physician LLC - Englewood
      • Dayton, Ohio, United States, 45409
        • Premier Blood and Cancer Center
      • Dublin, Ohio, United States, 43016
        • Dublin Methodist Hospital
      • Franklin, Ohio, United States, 45005-1066
        • Atrium Medical Center-Middletown Regional Hospital
      • Franklin, Ohio, United States, 45005
        • Dayton Physicians LLC-Atrium
      • Greenville, Ohio, United States, 45331
        • Wayne Hospital
      • Greenville, Ohio, United States, 45331
        • Dayton Physicians LLC-Wayne
      • Greenville, Ohio, United States, 45331
        • Miami Valley Cancer Care and Infusion
      • Kettering, Ohio, United States, 45429
        • Kettering Medical Center
      • Sylvania, Ohio, United States, 43560
        • ProMedica Flower Hospital
      • Toledo, Ohio, United States, 43606
        • ProMedica Toledo Hospital/Russell J Ebeid Children's Hospital
      • Troy, Ohio, United States, 45373
        • Upper Valley Medical Center
      • Troy, Ohio, United States, 45373
        • Dayton Physicians LLC - Troy
      • West Chester, Ohio, United States, 45069
        • University of Cincinnati Cancer Center-West Chester
    • Oklahoma
      • Oklahoma City, Oklahoma, United States, 73104
        • University of Oklahoma Health Sciences Center
      • Tulsa, Oklahoma, United States, 74146
        • Oklahoma Cancer Specialists and Research Institute-Tulsa
    • Oregon
      • Bend, Oregon, United States, 97701
        • Saint Charles Health System
      • Gresham, Oregon, United States, 97030
        • Legacy Mount Hood Medical Center
      • Newberg, Oregon, United States, 97132
        • Providence Newberg Medical Center
      • Portland, Oregon, United States, 97210
        • Legacy Good Samaritan Hospital and Medical Center
      • Portland, Oregon, United States, 97225
        • Providence Saint Vincent Medical Center
      • Portland, Oregon, United States, 97227
        • Kaiser Permanente Northwest
      • Tualatin, Oregon, United States, 97062
        • Legacy Meridian Park Hospital
    • Pennsylvania
      • Allentown, Pennsylvania, United States, 18103
        • Lehigh Valley Hospital-Cedar Crest
      • Altoona, Pennsylvania, United States, 16601
        • UPMC Altoona
      • Bethlehem, Pennsylvania, United States, 18017
        • Lehigh Valley Hospital - Muhlenberg
      • Danville, Pennsylvania, United States, 17822
        • Geisinger Medical Center
      • Erie, Pennsylvania, United States, 16505
        • UPMC Hillman Cancer Center Erie
      • Farrell, Pennsylvania, United States, 16121
        • UPMC Cancer Center at UPMC Horizon
      • Greensburg, Pennsylvania, United States, 15601
        • UPMC Cancer Centers - Arnold Palmer Pavilion
      • Greenville, Pennsylvania, United States, 16125
        • UPMC Hillman Cancer Center in Greenville/UPMC Horizon
      • Hershey, Pennsylvania, United States, 17033-0850
        • Penn State Milton S Hershey Medical Center
      • Jefferson Hills, Pennsylvania, United States, 15025
        • Jefferson Hospital
      • Johnstown, Pennsylvania, United States, 15901
        • UPMC-Johnstown/John P. Murtha Regional Cancer Center
      • Lewisburg, Pennsylvania, United States, 17837
        • Geisinger Medical Oncology-Lewisburg
      • Monroeville, Pennsylvania, United States, 15146
        • Forbes Hospital
      • Pittsburgh, Pennsylvania, United States, 15212
        • Allegheny General Hospital
      • Pittsburgh, Pennsylvania, United States, 15232
        • University of Pittsburgh Cancer Institute (UPCI)
      • Pittsburgh, Pennsylvania, United States, 15232
        • UPMC-Shadyside Hospital
      • Pittsburgh, Pennsylvania, United States, 15237
        • UPMC-Passavant Hospital
      • Pottsville, Pennsylvania, United States, 17901
        • Geisinger Cancer Services-Pottsville
      • West Reading, Pennsylvania, United States, 19611
        • Reading Hospital
      • Wexford, Pennsylvania, United States, 15090
        • Wexford Health and Wellness Pavilion
      • Wilkes-Barre, Pennsylvania, United States, 18711
        • Geisinger Wyoming Valley/Henry Cancer Center
    • South Carolina
      • Charleston, South Carolina, United States, 29401
        • Roper Hospital
      • Charleston, South Carolina, United States, 29414
        • Bon Secours Saint Francis Hospital
      • Charleston, South Carolina, United States, 29403
        • Charleston Oncology - Roper
      • Charleston, South Carolina, United States, 29414
        • Charleston Oncology - Saint Francis
    • South Dakota
      • Pierre, South Dakota, United States, 57501
        • Avera Cancer Institute at Pierre
      • Rapid City, South Dakota, United States, 57701
        • Rapid City Regional Hospital
      • Sioux Falls, South Dakota, United States, 57105
        • Avera Cancer Institute
      • Sioux Falls, South Dakota, United States, 57117-5134
        • Sanford USD Medical Center - Sioux Falls
      • Sioux Falls, South Dakota, United States, 57104
        • Sanford Cancer Center Oncology Clinic
      • Yankton, South Dakota, United States, 57078
        • Avera Cancer Institute at Yankton
    • Texas
      • Dallas, Texas, United States, 75235
        • Parkland Memorial Hospital
      • Dallas, Texas, United States, 75390
        • UT Southwestern/Simmons Cancer Center-Dallas
      • Houston, Texas, United States, 77030
        • Baylor College of Medicine/Dan L Duncan Comprehensive Cancer Center
      • Houston, Texas, United States, 77030
        • Memorial Hermann Texas Medical Center
      • Houston, Texas, United States, 77030
        • Ben Taub General Hospital
      • Humble, Texas, United States, 77338
        • Memorial Hermann Northeast Hospital
      • The Woodlands, Texas, United States, 77380
        • Memorial Hermann The Woodlands Hospital
    • Utah
      • American Fork, Utah, United States, 84003
        • American Fork Hospital / Huntsman Intermountain Cancer Center
      • Cedar City, Utah, United States, 84720
        • Sandra L Maxwell Cancer Center
      • Logan, Utah, United States, 84321
        • Logan Regional Hospital
      • Murray, Utah, United States, 84107
        • Intermountain Medical Center
      • Ogden, Utah, United States, 84403
        • McKay-Dee Hospital Center
      • Provo, Utah, United States, 84604
        • Utah Valley Regional Medical Center
      • Riverton, Utah, United States, 84065
        • Riverton Hospital
      • Salt Lake City, Utah, United States, 84112
        • Huntsman Cancer Institute/University of Utah
      • Salt Lake City, Utah, United States, 84143
        • LDS Hospital
      • St. George, Utah, United States, 84770
        • Saint George Regional Medical Center
    • Vermont
      • Berlin Corners, Vermont, United States, 05602
        • Central Vermont Medical Center/National Life Cancer Treatment
      • Burlington, Vermont, United States, 05401
        • University of Vermont Medical Center
      • Burlington, Vermont, United States, 05405
        • University of Vermont and State Agricultural College
      • Saint Johnsbury, Vermont, United States, 05819
        • Dartmouth Cancer Center - North
    • Virginia
      • Alexandria, Virginia, United States, 22304
        • Inova Alexandria Hospital
      • Fairfax, Virginia, United States, 22031
        • Inova Schar Cancer Institute
      • Fairfax, Virginia, United States, 22033
        • Inova Fair Oaks Hospital
      • Mechanicsville, Virginia, United States, 23116
        • Bon Secours Memorial Regional Medical Center
      • Midlothian, Virginia, United States, 23114
        • Bon Secours Saint Francis Medical Center
      • Richmond, Virginia, United States, 23235
        • VCU Massey Cancer Center at Stony Point
      • Richmond, Virginia, United States, 23226
        • Bon Secours Saint Mary's Hospital
      • Richmond, Virginia, United States, 23230
        • Bon Secours Cancer Institute at Reynolds Crossing
      • Richmond, Virginia, United States, 23229
        • Henrico Doctor's Hospital
      • Richmond, Virginia, United States, 23298
        • VCU Massey Comprehensive Cancer Center
    • Washington
      • Seattle, Washington, United States, 98101
        • Virginia Mason Medical Center
      • Vancouver, Washington, United States, 98686
        • Legacy Salmon Creek Hospital
      • Vancouver, Washington, United States, 98684
        • Legacy Cancer Institute Medical Oncology and Day Treatment
    • West Virginia
      • Morgantown, West Virginia, United States, 26506
        • West Virginia University Healthcare
    • Wisconsin
      • Antigo, Wisconsin, United States, 54409
        • Langlade Hospital and Cancer Center
      • Ashland, Wisconsin, United States, 54806
        • Duluth Clinic Ashland
      • Ashland, Wisconsin, United States, 54806
        • Northwest Wisconsin Cancer Center
      • Burlington, Wisconsin, United States, 53105
        • Aurora Cancer Care-Southern Lakes VLCC
      • Germantown, Wisconsin, United States, 53022
        • Aurora Health Care Germantown Health Center
      • Grafton, Wisconsin, United States, 53024
        • Aurora Cancer Care-Grafton
      • Green Bay, Wisconsin, United States, 54311
        • Aurora BayCare Medical Center
      • Green Bay, Wisconsin, United States, 54301
        • Saint Vincent Hospital Cancer Center Green Bay
      • Hayward, Wisconsin, United States, 54843
        • Essentia Health-Hayward Clinic
      • Johnson Creek, Wisconsin, United States, 53038
        • University of Wisconsin Carbone Cancer Center - Johnson Creek
      • Kenosha, Wisconsin, United States, 53142
        • Aurora Cancer Care-Kenosha South
      • La Crosse, Wisconsin, United States, 54601
        • Gundersen Lutheran Medical Center
      • Madison, Wisconsin, United States, 53792
        • University of Wisconsin Carbone Cancer Center - University Hospital
      • Madison, Wisconsin, United States, 53718
        • University of Wisconsin Carbone Cancer Center - Eastpark Medical Center
      • Marinette, Wisconsin, United States, 54143
        • Aurora Bay Area Medical Group-Marinette
      • Milwaukee, Wisconsin, United States, 53209
        • Aurora Cancer Care-Milwaukee
      • Milwaukee, Wisconsin, United States, 53215
        • Aurora Saint Luke's Medical Center
      • Milwaukee, Wisconsin, United States, 53233
        • Aurora Sinai Medical Center
      • Mukwonago, Wisconsin, United States, 53149
        • ProHealth D N Greenwald Center
      • New Richmond, Wisconsin, United States, 54017
        • Cancer Center of Western Wisconsin
      • Oconomowoc, Wisconsin, United States, 53066
        • ProHealth Oconomowoc Memorial Hospital
      • Oshkosh, Wisconsin, United States, 54904
        • Vince Lombardi Cancer Clinic - Oshkosh
      • Racine, Wisconsin, United States, 53406
        • Aurora Cancer Care-Racine
      • Rhinelander, Wisconsin, United States, 54501
        • Aspirus Cancer Care - James Beck Cancer Center
      • Sheboygan, Wisconsin, United States, 53081
        • Vince Lombardi Cancer Clinic-Sheboygan
      • Sheboygan, Wisconsin, United States, 53081
        • Saint Vincent Hospital Cancer Center at Sheboygan
      • Spooner, Wisconsin, United States, 54801
        • Essentia Health-Spooner Clinic
      • Stevens Point, Wisconsin, United States, 54481
        • Aspirus Cancer Care - Stevens Point
      • Sturgeon Bay, Wisconsin, United States, 54235-1495
        • Saint Vincent Hospital Cancer Center at Sturgeon Bay
      • Summit, Wisconsin, United States, 53066
        • Aurora Medical Center in Summit
      • Superior, Wisconsin, United States, 54880
        • Essentia Health Saint Mary's Hospital - Superior
      • Two Rivers, Wisconsin, United States, 54241
        • Vince Lombardi Cancer Clinic-Two Rivers
      • Waukesha, Wisconsin, United States, 53188
        • UW Cancer Center at ProHealth Care
      • Wausau, Wisconsin, United States, 54401
        • Aspirus Regional Cancer Center
      • Wauwatosa, Wisconsin, United States, 53226
        • Aurora Cancer Care-Milwaukee West
      • West Allis, Wisconsin, United States, 53227
        • Aurora West Allis Medical Center
      • Wisconsin Rapids, Wisconsin, United States, 54494
        • Aspirus Cancer Care - Wisconsin Rapids

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 70 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • STEP 1 REGISTRATION: No known IDH mutation. (If tested before step 1 registration, patients known to have IDH mutation in the tumor on local or other testing are ineligible and should not be registered)
  • STEP 1 REGISTRATION: Availability of formalin-fixed paraffin-embedded (FFPE) tumor tissue block and hematoxylin and eosin (H&E) stained slide to be sent for central pathology review for confirmation of histology and MGMT promoter methylation status. Note that tissue for central pathology review and central MGMT assessment must be received by the New York University (NYU) Center for Biospecimen Research and Development (CBRD) on or before postoperative calendar day 30. If tissue cannot be received by postoperative calendar day 30, then patients may NOT enroll on this trial as central pathology review will not be complete in time for the patient to start treatment no later than 8 weeks following surgery. Results of central pathology review and central MGMT analysis will generally be completed within 10 business days of receipt of tissue. Results will be entered by the central lab directly into Rave. Note: In the event of an additional tumor resection(s), tissue must be received within 30 days of the most recent resection and the latest resection must have been performed within 30 days after the initial resection. Surgical resection is required; stereotactic biopsy alone is not allowed because it will not provide sufficient tissue for MGMT analysis
  • STEP 1 REGISTRATION: Willing to use highly effective method of contraception for participants of childbearing potential (participants who may become pregnant or who may impregnate a partner) during therapy and for 6 months after completing treatment; this inclusion is necessary because the treatment in this study may be significantly teratogenic
  • STEP 1 REGISTRATION: The patient or a legally authorized representative must provide study-specific informed consent prior to study entry and, for patients treated in the United States (U.S.), authorization permitting release of personal health information
  • STEP 2 REGISTRATION: Histopathologically proven diagnosis of glioblastoma (or gliosarcoma as a subtype of glioblastoma) confirmed by central pathology review

  • STEP 2 REGISTRATION: MGMT promoter with methylation confirmed by central pathology review. Note: Patients with tissue that is insufficient or inadequate for analysis, fails MGMT testing, or has indeterminate or unmethylated MGMT promoter are excluded

    • Note: Any MGMT result other than methylated would require step 2 registration to be reported as a "central review failure"
  • STEP 2 REGISTRATION: Contrast-enhanced brain MRI performed either after surgery or prior to step 2 registration
  • STEP 2 REGISTRATION: IDH mutation testing by at least one method (such as immunohistochemistry for IDH1 R132H) must be performed as part of standard of care and no mutation must be found (i.e IDH wildtype). (If a mutation is identified then the patient will be ineligible and must be registered as ineligible at step 2.)
  • STEP 2 REGISTRATION: History/physical examination within 28 days prior to step 2 registration
  • STEP 2 REGISTRATION: Karnofsky performance status (KPS) >= 70 within 28 days prior to step 2 registration
  • STEP 2 REGISTRATION: Neurologic function assessment within 28 days prior to step 2 registration
  • STEP 2 REGISTRATION: Age 18-70 years
  • STEP 2 REGISTRATION: Hemoglobin >= 10 g/dl (Note: the use of transfusion or other intervention to achieve hemoglobin [Hgb] >= 10.0 g/dl is acceptable) (Within 14 days prior to step 2 registration)
  • STEP 2 REGISTRATION: Leukocytes >= 2,000/mm^3 (Within 14 days prior to step 2 registration)
  • STEP 2 REGISTRATION: Absolute neutrophil count >= 1,500/mm^3 (Within 14 days prior to step 2 registration)
  • STEP 2 REGISTRATION: Platelets >= 100,000/mm^3 (Within 14 days prior to step 2 registration)
  • STEP 2 REGISTRATION: Total bilirubin =< 1.5 x institutional/lab upper limit of normal (ULN) (Within 14 days prior to step 2 registration)
  • STEP 2 REGISTRATION: Aspartate aminotransferase (AST) (serum glutamic-oxaloacetic transaminase [SGOT]) =< 2.5 x ULN (Within 14 days prior to step 2 registration)
  • STEP 2 REGISTRATION: Alanine aminotransferase (ALT) (serum glutamate pyruvate transaminase [SGPT]) =< 2.5 x ULN (Within 14 days prior to step 2 registration)
  • STEP 2 REGISTRATION: Serum creatinine =< 1.5 x ULN OR creatinine clearance (CrCl) >= 50 mL/min (if using the Cockcroft-Gault formula) (Within 14 days prior to step 2 registration)

  • STEP 2 REGISTRATION: For patients with evidence of chronic hepatitis B virus (HBV) infection, the HBV viral load must be undetectable on suppressive therapy, if indicated

    • Note: Known positive test for hepatitis B virus surface antigen (HBV sAg) indicating acute or chronic infection would make the patient ineligible unless the viral load becomes undetectable on suppressive therapy. Patients who are immune to hepatitis B (anti-hepatitis B surface antibody positive) are eligible (e.g. patients immunized against hepatitis B)

  • STEP 2 REGISTRATION: For patients with a history of hepatitis C virus (HCV) infection must have been treated and cured. For patients with HCV infection who are currently on treatment, they are eligible if they have an undetectable HCV viral load

    • Note: Known positive test for hepatitis C virus ribonucleic acid (HCV ribonucleic acid [RNA]) indicating acute or chronic infection would make the patient ineligible unless the viral load becomes undetectable on suppressive therapy
  • STEP 2 REGISTRATION: Known human immunodeficiency virus (HIV) infected patients on effective anti-retroviral therapy with undetectable viral load within 6 months prior to step 2 registration are eligible for this trial. Testing is not required for entry into protocol

  • STEP 2 REGISTRATION: Negative serum or urine pregnancy test (in persons of childbearing potential) within 14 days prior to step 2 registration

    • Childbearing potential is defined as any person who has experienced menarche and who has not undergone surgical sterilization (hysterectomy or bilateral oophorectomy) or who is not postmenopausal

Exclusion Criteria:

  • STEP 2 REGISTRATION: Prior therapy for tumor except for resection or prior laser interstitial thermal therapy (LITT). For example, prior chemotherapy, immunotherapy, or targeted therapy for GBM or lower grade glioma is disallowed (including but not limited to temozolomide, lomustine, bevacizumab, any viral therapy, ipilimumab or other CTLA-4 antibody, PD-1 antibody, CD-137 agonist, CD40 antibody, PDL-1 or 2 antibody, vaccine therapy, polio or similar viral injection as treatment for the tumor, and/or any other antibody or drug specifically targeting T-cell co-stimulation or immune checkpoint pathways) as is Gliadel wafer, radiotherapy, radiosurgery, vaccine or other immunotherapy, brachytherapy, or convection enhanced delivery

    • Note: 5-aminolevulinic acid (ALA)-mediated fluorescent guided resection (FGR) photodynamic therapy (PDT) or fluorescein administered prior to/during surgery to aid resection is not exclusionary and is not considered a chemotherapy or intracerebral agent. Prior laser interstitial thermal therapy (LITT) is allowed
  • STEP 2 REGISTRATION: Current or planned treatment with any other investigational agents for the study cancer
  • STEP 2 REGISTRATION: Definitive clinical or radiologic evidence of metastatic disease outside the brain
  • STEP 2 REGISTRATION: Prior invasive malignancy (except non-melanomatous skin cancer, cervical cancer in situ and melanoma in situ) unless disease free for a minimum of 2 years
  • STEP 2 REGISTRATION: Prior radiotherapy to the head or neck that would result in overlap of radiation therapy fields
  • STEP 2 REGISTRATION: Pregnancy and individuals unwilling to discontinue nursing due to the potential teratogenic effects and potential risk for adverse events in nursing infants
  • STEP 2 REGISTRATION: History of allergic reactions attributed to compounds of similar chemical or biologic composition to temozolomide or lomustine
  • STEP 2 REGISTRATION: History of pulmonary fibrosis

  • STEP 2 REGISTRATION: Uncontrolled intercurrent illness including, but not limited to:

    • Ongoing or active infection requiring intravenous (IV) antibiotics, IV antiviral, or IV antifungal treatment
    • Symptomatic congestive heart failure, defined as New York Heart Association Functional Classification III/IV (Note: Patients with known history or current symptoms of cardiac disease, or history of treatment with cardiotoxic agents, should have a clinical risk assessment of cardiac function using the New York Heart Association Functional Classification)
    • Unstable angina pectoris within 6 months prior to Step 2 registration
    • Uncontrolled cardiac arrhythmia
    • Psychiatric illness/social situations that would limit compliance with study requirements
  • STEP 2 REGISTRATION: Evidence of diffuse leptomeningeal disease that requires whole brain irradiation

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Arm I (radiation therapy, temozolomide)
Patients undergo radiation therapy 5 days per week and receive temozolomide PO QD for 6 weeks in the absence of disease progression or unacceptable toxicity. Patients then receive temozolomide PO QD on days 1-5 of each cycle. Treatment repeats every 28 days for 6 cycles in the absence of disease progression or unacceptable toxicity. Patients also undergo MRI throughout the trial.
Other: Questionnaire Administration
Ancillary studies
Procedure: Magnetic Resonance Imaging
Undergo MRI
Other Names:
  • MRI
  • Magnetic Resonance
  • Magnetic Resonance Imaging Scan
  • Medical Imaging, Magnetic Resonance / Nuclear Magnetic Resonance
  • MR
  • MR Imaging
  • MRI Scan
  • NMR Imaging
  • NMRI
  • Nuclear Magnetic Resonance Imaging
  • Magnetic Resonance Imaging (MRI)
  • sMRI
  • Magnetic resonance imaging (procedure)
  • MRIs
  • Structural MRI
Drug: Temozolomide
Given PO
Other Names:
  • Temodar
  • SCH 52365
  • Temodal
  • Temcad
  • Methazolastone
  • RP-46161
  • Temomedac
  • TMZ
  • CCRG-81045
  • Imidazo[5,1-d]-1,2,3,5-tetrazine-8-carboxamide, 3, 4-dihydro-3-methyl-4-oxo-
  • M & B 39831
  • M and B 39831
  • Gliotem
  • Temizole
Radiation: Photon Beam Radiation Therapy
Undergo radiation therapy
Other Names:
  • Photon EBRT
  • Photon External Beam Radiotherapy
  • Radiation, Photon Beam
  • External beam radiation therapy using photons (procedure)
  • Photon
  • PHOTON Therapy
Experimental: ARM II (radiation therapy, temozolomide, lomustine)
Patients undergo radiation therapy 5 days per week for 6 weeks in the absence of disease progression or unacceptable toxicity. Patients also receive lomustine PO on day 1 of each cycle and temozolomide PO QD on days 2-6 of each cycle. Treatment repeats every 42 days for 6 cycles in the absence of disease progression or unacceptable toxicity. Patients also undergo MRI throughout the trial.
Other: Questionnaire Administration
Ancillary studies
Procedure: Magnetic Resonance Imaging
Undergo MRI
Other Names:
  • MRI
  • Magnetic Resonance
  • Magnetic Resonance Imaging Scan
  • Medical Imaging, Magnetic Resonance / Nuclear Magnetic Resonance
  • MR
  • MR Imaging
  • MRI Scan
  • NMR Imaging
  • NMRI
  • Nuclear Magnetic Resonance Imaging
  • Magnetic Resonance Imaging (MRI)
  • sMRI
  • Magnetic resonance imaging (procedure)
  • MRIs
  • Structural MRI
Drug: Temozolomide
Given PO
Other Names:
  • Temodar
  • SCH 52365
  • Temodal
  • Temcad
  • Methazolastone
  • RP-46161
  • Temomedac
  • TMZ
  • CCRG-81045
  • Imidazo[5,1-d]-1,2,3,5-tetrazine-8-carboxamide, 3, 4-dihydro-3-methyl-4-oxo-
  • M & B 39831
  • M and B 39831
  • Gliotem
  • Temizole
Drug: Lomustine
Given PO
Other Names:
  • CCNU
  • CeeNU
  • Gleostine
  • 1-(2-Chloroethyl)-3-cyclohexyl-1-nitrosourea
  • 1-Nitrosourea, 1-(2-chloroethyl)-3-cyclohexyl-
  • Belustin
  • Belustine
  • Cecenu
  • Chloroethylcyclohexylnitrosourea
  • Citostal
  • Lomeblastin
  • Lomustinum
  • Lucostin
  • Lucostine
  • N-(2-Chloroethyl)-N'-cyclohexyl-N-nitrosourea
  • Prava
  • RB-1509
  • WR-139017
Radiation: Photon Beam Radiation Therapy
Undergo radiation therapy
Other Names:
  • Photon EBRT
  • Photon External Beam Radiotherapy
  • Radiation, Photon Beam
  • External beam radiation therapy using photons (procedure)
  • Photon
  • PHOTON Therapy

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Overall survival
Time Frame: From randomization to death due to any cause, assessed up to 5 years from randomization
The Kaplan-Meier method will be used to estimate survival distribution for each treatment arm.
From randomization to death due to any cause, assessed up to 5 years from randomization

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Progression free survival (PFS)
Time Frame: From randomization to disease progression or death due to any cause, whichever occurs first, assessed up to 5 years from randomization
Analysis will consist of estimation of the PFS distribution of each treatment arm via the Kaplan-Meier method and a stratified log-rank test. Additional analyses may consist of estimating the hazard ratio via the Cox proportional hazards model, accounting for other prognostic covariates (and evaluating whether the proportional hazards assumption holds or whether any treatment effect is notably time-varying), and evaluating for potential treatment by prognostic covariate interactions.
From randomization to disease progression or death due to any cause, whichever occurs first, assessed up to 5 years from randomization
Incidence of adverse events
Time Frame: Up to 5 years from randomization
Adverse events (AEs) will be graded according to Common Terminology Criteria for Adverse Events version 5.0. Comprehensive summaries of all AEs by treatment arm will be generated and examined.
Up to 5 years from randomization
Patient reported outcomes
Time Frame: Up to 5 years from randomization
Measured by the MD Anderson Symptom Inventory - Brain Tumor (MDASI-BT) in patients with newly diagnosed glioblastoma with MGMT promoter methylation. Short-term" and "long-term" MDASI-BT, will be evaluated separately.
Up to 5 years from randomization

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
Absolute lymphocyte counts
Time Frame: Up to 5 years from randomization
Will assess the association between absolute lymphocyte counts and outcomes.
Up to 5 years from randomization
CD4+ lymphocyte counts
Time Frame: Up to 5 years from randomization
Will assess the association between absolute lymphocyte counts and outcomes.
Up to 5 years from randomization
Estimation of the primary outcome treatment effect by sex
Time Frame: Up to 5 years from randomization
Estimates of treatment effect and the corresponding 95% confidence intervals (CIs) will be provided.
Up to 5 years from randomization
Estimation of the primary outcome treatment effect by ethnicity
Time Frame: Up to 5 years from randomization
Estimates of treatment effect and the corresponding 95% CIs will be provided.
Up to 5 years from randomization
Estimation of the primary outcome treatment effect by race
Time Frame: Up to 5 years from randomization
Estimates of treatment effect and the corresponding 95% CIs will be provided.
Up to 5 years from randomization

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

NRG Oncology

Collaborators

National Cancer Institute (NCI)

Investigators

  • Principal Investigator: Fabio M Iwamoto, NRG Oncology

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

March 28, 2022

Primary Completion (Actual)

February 12, 2026

Study Completion (Estimated)

August 8, 2026

Study Registration Dates

First Submitted

October 15, 2021

First Submitted That Met QC Criteria

October 15, 2021

First Posted (Actual)

October 27, 2021

Study Record Updates

Last Update Posted (Actual)

May 19, 2026

Last Update Submitted That Met QC Criteria

May 15, 2026

Last Verified

May 1, 2026

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • NRG-BN011 (Other Identifier: CTEP)
  • U10CA180868 (U.S. NIH Grant/Contract)
  • NCI-2021-10331 (Registry Identifier: CTRP (Clinical Trial Reporting Program))

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

NCI is committed to sharing data in accordance with NIH policy. For more details on how clinical trial data is shared, access the link to the NIH data sharing policy page.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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