Temozolomide With or Without Veliparib in Treating Patients With Newly Diagnosed Glioblastoma Multiforme
Glioblastoma, Gliosarcoma
About this trial
This is an interventional treatment trial for Glioblastoma
Eligibility Criteria
Inclusion Criteria:
- Histologic documentation: newly diagnosed World Health Organization (WHO) grade IV intracranial glioblastoma or gliosarcoma; GBM with oligodendroglial features are NOT PERMITTED in this study if they are 1p19q codeleted; sites submitting GBM with oligodendroglial features will be asked to provide results of 1p/19q codeletion status
- Sufficient tissue available for central pathology review and MGMT methylation status evaluation
- Patients who have had a local MGMT testing that is unmethylated are not allowed to participate
- Tumor MGMT promoter hypermethylation determined by central testing at MD Anderson
- Confirmation by central pathology review of WHO grade IV glioblastoma or gliosarcoma
- Absolute neutrophil count (ANC) >= 1500 cells/mm^3 (within 14 days prior to study registration)
- Platelets >= 100,000 cells/mm^3 (within 14 days prior to study registration)
- Creatinine =< 1.5 x upper limit of normal (ULN) (within 14 days prior to study registration)
- Bilirubin =< 1.5 x ULN (within 14 days prior to study registration; unless patient has Gilbert's disease)
- Alanine aminotransferase (ALT) =< 3 x ULN (within 14 days prior to study registration)
- Aspartate aminotransferase (AST) =< 3 x ULN (within 14 days prior to study registration)
- Eastern Cooperative Oncology Group (ECOG) performance status =< 2
- Measurable disease or non-measurable disease; extent of resection: patients with complete resection, partial resection, or biopsy are eligible
- Progression: patients deemed to have progressive disease based on clinical deterioration after chemoradiation or radiographic progression outside of the radiation field are not eligible; patients deemed to have pseudoprogression are eligible
Prior treatment:
- Must have completed standard radiotherapy and concomitant TMZ therapy as defined and determined by the study oncologist
- Besides concomitant TMZ with radiation, no other therapy (neo-adjuvant or adjuvant) can be given prior to study registration, including chemotherapy (also including Gliadel/carmustine [BCNU] wafers), biologics, immunotherapy, radiation therapy; the only exception is the Optune device (NovoTTF-100A), which may be started any time after end of radiation therapy up through the initiation of Cycle 1; intent to use Optune must be declared at registration for stratification
- No prior allogeneic bone marrow transplant or double umbilical cord blood transplantation
Not pregnant and not nursing; females of childbearing potential must have negative urine or serum pregnancy test within 7 days of registration but before start of treatment; a female of childbearing potential is a sexually mature female who:
- Has not undergone a hysterectomy or bilateral oophorectomy; or
- Has not been naturally postmenopausal for at least 12 consecutive months (i.e., has had menses at any time in the preceding 12 consecutive months)
- Concomitant medications: patients receiving anticoagulation should be on stable dose 2 weeks prior to registration
Comorbid conditions: patients are unable to participate due to the following:
- Generalized or partial seizure disorder that is uncontrolled at the time of registration; the definition of controlled generalized seizures is patients must be on a stable dose of anti-seizure medication and without generalized seizures for at least 10 days prior to registration; the definition of controlled partial seizures is patients must be on a stable dose of anti-seizure medication for at least 10 days prior to registration; patients with occasional breakthrough partial seizures are allowed at treating physician's discretion
- Grade 3 or 4 thromboembolic disease within 6 months (mo) of registration
- Known history of prolonged QT syndrome
- No history of major surgery =< 14 days prior to registration
Patients must have adequate organ and marrow function measured within 28 days prior to administration of ABT-888 as defined below:
- >= 10.0 g/dL hemoglobin (Hb) with no blood transfusion in the past 28 days
- No Patients with treatment-related acute myeloid leukemia (AML) (t-AML)/myelodysplastic syndrome (MDS) or with features suggestive of AML/MDS
Sites / Locations
- University of Alabama at Birmingham Cancer Center
- Katmai Oncology Group
- Providence Alaska Medical Center
- Mayo Clinic in Arizona
- Banner University Medical Center - Tucson
- University of Arkansas for Medical Sciences
- Kaiser Permanente-Deer Valley Medical Center
- Providence Saint Joseph Medical Center/Disney Family Cancer Center
- Mills-Peninsula Medical Center
- John Muir Medical Center-Concord Campus
- Kaiser Permanente-Fremont
- Fresno Cancer Center
- Kaiser Permanente-Fresno
- Saint Jude Medical Center
- UC San Diego Moores Cancer Center
- Kaiser Permanente Los Angeles Medical Center
- Los Angeles County-USC Medical Center
- USC / Norris Comprehensive Cancer Center
- Kaiser Permanente-Modesto
- USC Norris Oncology/Hematology-Newport Beach
- Kaiser Permanente Oakland-Broadway
- Kaiser Permanente-Oakland
- Saint Joseph Hospital - Orange
- Kaiser Permanente-Rancho Cordova Cancer Center
- Kaiser Permanente-Redwood City
- Kaiser Permanente-Richmond
- Rohnert Park Cancer Center
- Kaiser Permanente-Roseville
- Sutter Roseville Medical Center
- The Permanente Medical Group-Roseville Radiation Oncology
- Sutter Medical Center Sacramento
- University of California Davis Comprehensive Cancer Center
- Kaiser Permanente-South Sacramento
- South Sacramento Cancer Center
- Kaiser Permanente - Sacramento
- UC San Diego Medical Center - Hillcrest
- Kaiser Permanente-San Francisco
- UCSF Medical Center-Parnassus
- Kaiser Permanente-Santa Teresa-San Jose
- Kaiser Permanente San Leandro
- Kaiser Permanente-San Rafael
- Kaiser Permanente Medical Center - Santa Clara
- Palo Alto Medical Foundation-Santa Cruz
- Kaiser Permanente-Santa Rosa
- Kaiser Permanente Cancer Treatment Center
- Kaiser Permanente-South San Francisco
- Kaiser Permanente-Stockton
- Northbay Cancer Center
- Kaiser Permanente Medical Center-Vacaville
- Kaiser Permanente-Vallejo
- Kaiser Permanente-Walnut Creek
- John Muir Medical Center-Walnut Creek
- UCHealth University of Colorado Hospital
- Boulder Community Hospital
- Rocky Mountain Cancer Centers-Boulder
- Penrose-Saint Francis Healthcare
- Rocky Mountain Cancer Centers-Penrose
- Kaiser Permanente-Franklin
- Swedish Medical Center
- Poudre Valley Hospital
- North Colorado Medical Center
- Kaiser Permanente-Rock Creek
- Rocky Mountain Cancer Centers-Littleton
- Littleton Adventist Hospital
- Kaiser Permanente-Lone Tree
- Rocky Mountain Cancer Centers-Longmont
- McKee Medical Center
- SCL Health Lutheran Medical Center
- Hartford Hospital
- Smilow Cancer Hospital Care Center at Saint Francis
- Midstate Medical Center
- The Hospital of Central Connecticut
- Yale University
- Boca Raton Regional Hospital
- UM Sylvester Comprehensive Cancer Center at Deerfield Beach
- Memorial Regional Hospital/Joe DiMaggio Children's Hospital
- Mayo Clinic in Florida
- Lakeland Regional Health Hollis Cancer Center
- Mount Sinai Medical Center
- University of Miami Miller School of Medicine-Sylvester Cancer Center
- AdventHealth Orlando
- Orlando Health Cancer Institute
- Memorial Hospital West
- Moffitt Cancer Center
- Piedmont Hospital
- Emory University Hospital/Winship Cancer Institute
- Northside Hospital
- John B Amos Cancer Center
- Northeast Georgia Medical Center-Gainesville
- Hawaii Cancer Care Inc - Waterfront Plaza
- Queen's Cancer Cenrer - POB I
- Queen's Medical Center
- Straub Clinic and Hospital
- Hawaii Cancer Care Inc-Liliha
- Queen's Cancer Center - Kuakini
- Saint Alphonsus Cancer Care Center-Boise
- Kootenai Clinic Cancer Services - Post Falls
- Saint Joseph Medical Center
- Northwestern University
- Rush University Medical Center
- Cancer Care Specialists of Illinois - Decatur
- Decatur Memorial Hospital
- Crossroads Cancer Center
- NorthShore University HealthSystem-Evanston Hospital
- Northwestern Medicine Cancer Center Delnor
- NorthShore University HealthSystem-Glenbrook Hospital
- NorthShore University HealthSystem-Highland Park Hospital
- Edward Hospital/Cancer Center
- Advocate Lutheran General Hospital
- Illinois CancerCare-Peoria
- Methodist Medical Center of Illinois
- OSF Saint Francis Medical Center
- Edward Hospital/Cancer Center?Plainfield
- Central Illinois Hematology Oncology Center
- Southern Illinois University School of Medicine
- Memorial Medical Center
- Carle Cancer Center
- Northwestern Medicine Cancer Center Warrenville
- Parkview Hospital Randallia
- Franciscan Health Indianapolis
- Reid Health
- Memorial Hospital of South Bend
- Physicians' Clinic of Iowa PC
- Medical Oncology and Hematology Associates-West Des Moines
- Mercy Cancer Center-West Lakes
- Iowa Methodist Medical Center
- Mercy Medical Center - Des Moines
- Mission Cancer and Blood - Laurel
- Mercy Medical Center - North Iowa
- Siouxland Regional Cancer Center
- Mercy Medical Center-West Lakes
- Cancer Center of Kansas - Chanute
- Cancer Center of Kansas - Dodge City
- Cancer Center of Kansas - El Dorado
- Cancer Center of Kansas - Fort Scott
- Cancer Center of Kansas-Independence
- Cancer Center of Kansas-Kingman
- Lawrence Memorial Hospital
- Cancer Center of Kansas-Liberal
- Cancer Center of Kansas - McPherson
- Cancer Center of Kansas - Newton
- Menorah Medical Center
- Cancer Center of Kansas - Parsons
- Cancer Center of Kansas - Pratt
- Cancer Center of Kansas - Salina
- Cancer Center of Kansas - Wellington
- Cancer Center of Kansas-Wichita Medical Arts Tower
- Ascension Via Christi Hospitals Wichita
- Cancer Center of Kansas - Wichita
- Cancer Center of Kansas - Winfield
- Baptist Health Corbin
- Baptist Health Lexington
- University of Kentucky/Markey Cancer Center
- Baptist Health Louisville
- Baptist Health Madisonville/Merle Mahr Cancer Center
- Baptist Health Paducah
- Mary Bird Perkins Cancer Center
- The NeuroMedical Center-Clinic
- Ochsner Medical Center Jefferson
- Eastern Maine Medical Center
- Lafayette Family Cancer Center-EMMC
- Maine Center for Cancer Medicine-Scarborough
- Maine Center for Cancer Medicine-Topsham
- Anne Arundel Medical Center
- Sinai Hospital of Baltimore
- Northwest Hospital Center
- TidalHealth Peninsula Regional
- Massachusetts General Hospital Cancer Center
- Dana-Farber Cancer Institute
- Simonds-Sinon Regional Cancer Center
- Lowell General Hospital
- UMass Memorial Medical Center - University Campus
- Saint Joseph Mercy Hospital
- University of Michigan Comprehensive Cancer Center
- Ascension Saint John Hospital
- Green Bay Oncology - Escanaba
- Genesys Hurley Cancer Institute
- Spectrum Health at Butterworth Campus
- Trinity Health Grand Rapids Hospital
- Green Bay Oncology - Iron Mountain
- West Michigan Cancer Center
- Sparrow Hospital
- Trinity Health Saint Mary Mercy Livonia Hospital
- Ascension Providence Hospitals - Novi
- Saint Joseph Mercy Oakland
- Spectrum Health Reed City Hospital
- William Beaumont Hospital-Royal Oak
- Ascension Saint Mary's Hospital
- Lakeland Medical Center Saint Joseph
- Marie Yeager Cancer Center
- Ascension Providence Hospitals - Southfield
- Munson Medical Center
- University of Michigan Health - West
- Sanford Joe Lueken Cancer Center
- Mercy Hospital
- Essentia Health Cancer Center
- Saint Luke's Hospital of Duluth
- Fairview Southdale Hospital
- Abbott-Northwestern Hospital
- Hennepin County Medical Center
- Health Partners Inc
- North Memorial Medical Health Center
- Mayo Clinic in Rochester
- Coborn Cancer Center at Saint Cloud Hospital
- Regions Hospital
- United Hospital
- Rice Memorial Hospital
- Minnesota Oncology Hematology PA-Woodbury
- University of Mississippi Medical Center
- Southeast Cancer Center
- Saint Luke's Hospital
- Centerpoint Medical Center LLC
- Saint Luke's Hospital of Kansas City
- Saint Luke's East - Lee's Summit
- Washington University School of Medicine
- Missouri Baptist Medical Center
- Mercy Hospital Saint Louis
- Mercy Hospital Springfield
- CoxHealth South Hospital
- Billings Clinic Cancer Center
- Bozeman Deaconess Hospital
- Benefis Healthcare- Sletten Cancer Institute
- CHI Health Saint Francis
- CHI Health Good Samaritan
- Faith Regional Health Services Carson Cancer Center
- Nebraska Methodist Hospital
- Alegent Health Immanuel Medical Center
- Alegent Health Bergan Mercy Medical Center
- Nebraska Cancer Specialists - Omaha
- Creighton University Medical Center
- University of Nebraska Medical Center
- Renown Regional Medical Center
- New Hampshire Oncology Hematology PA-Concord
- Dartmouth Hitchcock Medical Center/Dartmouth Cancer Center
- Solinsky Center for Cancer Care
- Portsmouth Regional Hospital
- John F Kennedy Medical Center
- Hackensack University Medical Center
- Saint Barnabas Medical Center
- Rutgers Cancer Institute of New Jersey-Robert Wood Johnson University Hospital
- Rutgers Cancer Institute of New Jersey
- The Valley Hospital-Luckow Pavilion
- Valley Hospital
- Overlook Hospital
- Valley Health System-Hematology/Oncology
- Montefiore Medical Center - Moses Campus
- Roswell Park Cancer Institute
- Mary Imogene Bassett Hospital
- Mount Sinai Hospital
- University of Rochester
- State University of New York Upstate Medical University
- Mission Hospital
- UNC Lineberger Comprehensive Cancer Center
- East Carolina University
- Vidant Oncology-Kinston
- Wake Forest University Health Sciences
- Sanford Broadway Medical Center
- Sanford Clinic North-Fargo
- Sanford Roger Maris Cancer Center
- Altru Cancer Center
- Cleveland Clinic Akron General
- Cleveland Clinic Mercy Hospital
- Adena Regional Medical Center
- University of Cincinnati Cancer Center-UC Medical Center
- Cleveland Clinic Foundation
- Ohio State University Comprehensive Cancer Center
- Mount Carmel East Hospital
- Riverside Methodist Hospital
- Grant Medical Center
- Good Samaritan Hospital - Dayton
- Miami Valley Hospital
- Dayton Physician LLC-Miami Valley Hospital North
- Miami Valley Hospital North
- Armes Family Cancer Center
- Blanchard Valley Hospital
- Orion Cancer Care
- Wayne Hospital
- Toledo Clinic Cancer Centers-Maumee
- Saint Charles Hospital
- Mercy Health Perrysburg Cancer Center
- ProMedica Flower Hospital
- Mercy Health - Saint Anne Hospital
- Toledo Clinic Cancer Centers-Toledo
- University of Cincinnati Cancer Center-West Chester
- University of Oklahoma Health Sciences Center
- Oklahoma Cancer Specialists and Research Institute-Tulsa
- Legacy Good Samaritan Hospital and Medical Center
- Providence Portland Medical Center
- Providence Saint Vincent Medical Center
- Kaiser Permanente Northwest
- Jefferson Abington Hospital
- Lehigh Valley Hospital-Cedar Crest
- Bryn Mawr Hospital
- Geisinger Medical Center
- UPMC Pinnacle Cancer Center/Community Osteopathic Campus
- Lancaster General Hospital
- Paoli Memorial Hospital
- Allegheny General Hospital
- University of Pittsburgh Cancer Institute (UPCI)
- Guthrie Medical Group PC-Robert Packer Hospital
- Geisinger Wyoming Valley/Henry Cancer Center
- UPMC Susquehanna
- Lankenau Medical Center
- Rhode Island Hospital
- Prisma Health Cancer Institute - Spartanburg
- Roper Hospital
- Charleston Oncology - Roper
- Lowcountry Hematology Oncology PA-North Charleston
- Bon Secours Saint Francis Hospital
- Charleston Oncology - Saint Francis
- Lowcountry Hematology Oncology PA-West Ashley
- Medical University of South Carolina
- Prisma Health Cancer Institute - Easley
- Gibbs Cancer Center-Gaffney
- Greenville Health System Cancer Institute-Andrews
- Saint Francis Hospital
- Prisma Health Cancer Institute - Butternut
- Prisma Health Cancer Institute - Faris
- Prisma Health Greenville Memorial Hospital
- Saint Francis Cancer Center
- Prisma Health Cancer Institute - Eastside
- Prisma Health Cancer Institute - Greer
- Gibbs Cancer Center-Pelham
- Lowcountry Hematology Oncology PA-Mount Pleasant
- Prisma Health Cancer Institute - Seneca
- Spartanburg Medical Center
- Avera Cancer Institute-Aberdeen
- Rapid City Regional Hospital
- Sanford Cancer Center Oncology Clinic
- Avera Cancer Institute
- Sanford USD Medical Center - Sioux Falls
- Wellmont Holston Valley Hospital and Medical Center
- University of Tennessee - Knoxville
- Vanderbilt University/Ingram Cancer Center
- UT Southwestern/Simmons Cancer Center-Dallas
- Brooke Army Medical Center
- Baylor College of Medicine/Dan L Duncan Comprehensive Cancer Center
- Ben Taub General Hospital
- M D Anderson Cancer Center
- Memorial Hermann Texas Medical Center
- Huntsman Cancer Institute/University of Utah
- University of Vermont and State Agricultural College
- University of Virginia Cancer Center
- Danville Regional Medical Center
- Inova Fairfax Hospital
- MultiCare Auburn Medical Center
- PeaceHealth Saint Joseph Medical Center
- Highline Medical Center-Main Campus
- MultiCare Gig Harbor Medical Park
- Jefferson Healthcare
- MultiCare Good Samaritan Hospital
- Virginia Mason Medical Center
- Franciscan Research Center-Northwest Medical Plaza
- MultiCare Tacoma General Hospital
- Northwest Medical Specialties PLLC
- PeaceHealth Southwest Medical Center
- Edwards Comprehensive Cancer Center
- West Virginia University Healthcare
- Aurora Cancer Care-Southern Lakes VLCC
- HSHS Sacred Heart Hospital
- Marshfield Clinic Cancer Center at Sacred Heart
- Aurora Health Center-Fond du Lac
- Aurora Health Care Germantown Health Center
- Aurora Cancer Care-Grafton
- Green Bay Oncology at Saint Vincent Hospital
- Saint Vincent Hospital Cancer Center Green Bay
- Green Bay Oncology Limited at Saint Mary's Hospital
- Saint Vincent Hospital Cancer Center at Saint Mary's
- Aurora BayCare Medical Center
- Mercyhealth Hospital and Cancer Center - Janesville
- Gundersen Lutheran Medical Center
- University of Wisconsin Carbone Cancer Center
- Aurora Bay Area Medical Group-Marinette
- Marshfield Medical Center-Marshfield
- Marshfield Medical Center
- Aurora Cancer Care-Milwaukee
- Aurora Saint Luke's Medical Center
- Medical College of Wisconsin
- Aurora Sinai Medical Center
- Marshfield Clinic-Minocqua Center
- ProHealth D N Greenwald Center
- ProHealth Oconomowoc Memorial Hospital
- Saint Vincent Hospital Cancer Center at Oconto Falls
- Vince Lombardi Cancer Clinic - Oshkosh
- Aurora Cancer Care-Racine
- Lakeview Medical Center-Marshfield Clinic
- Marshfield Medical Center-Rice Lake
- Vince Lombardi Cancer Clinic-Sheboygan
- Saint Vincent Hospital Cancer Center at Sturgeon Bay
- Green Bay Oncology - Sturgeon Bay
- Aurora Medical Center in Summit
- Vince Lombardi Cancer Clinic-Two Rivers
- Aurora Cancer Care-Waukesha
- ProHealth Waukesha Memorial Hospital
- UW Cancer Center at ProHealth Care
- Aurora Cancer Care-Milwaukee West
- Aurora West Allis Medical Center
- Diagnostic and Treatment Center
- Marshfield Medical Center - Weston
- Fundacion De Investigacion de Diego
Arms of the Study
Arm 1
Arm 2
Experimental
Placebo Comparator
Arm I (temozolomide, veliparib)
Arm II (temozolomide, placebo)
Patients receive temozolomide PO QD on days 1-5 and veliparib PO BID on days 1-7. Treatment repeats every 28 days for 6 cycles in the absence of disease progression (confirmed progression) or unacceptable toxicity.
Patients receive temozolomide as in Arm I and placebo PO BID on days 1-7. Treatment repeats every 28 days for 6 cycles in the absence of disease progression (confirmed progression) or unacceptable toxicity.