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Temozolomide With or Without Veliparib in Treating Patients With Newly Diagnosed Glioblastoma Multiforme

Sponsor
National Cancer Institute (NCI) (NIH)
Overall Status
Active, not recruiting
CT.gov ID
NCT02152982
Collaborator
(none)
447
Enrollment
400
Locations
2
Arms
96
Anticipated Duration (Months)
1.1
Patients Per Site
0
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

This randomized phase II/III trial studies how well temozolomide and veliparib work compared to temozolomide alone in treating patients with newly diagnosed glioblastoma multiforme. Drugs used in chemotherapy, such as temozolomide, work in different ways to stop the growth of tumor cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Veliparib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. It is not yet known whether temozolomide is more effective with or without veliparib in treating glioblastoma multiforme.

Condition or Disease Intervention/Treatment Phase
Phase 2/Phase 3

Detailed Description

PRIMARY OBJECTIVE:
  1. Test whether the experimental combination of ABT-888 (veliparib) combined with TMZ (temozolomide), compared to the control of placebo combined with TMZ, significantly extends overall survival in newly diagnosed glioblastoma multiforme (GBM) patients with tumor MGMT promoter hypermethylation.
SECONDARY OBJECTIVES:

  1. Test whether the experimental treatment significantly extends progression-free survival.

  2. Test whether the experimental treatment improves objective tumor response. III. Test whether the experimental treatment is associated with significantly greater rates of grade 3 or higher adverse events.

CORRELATIVE SCIENCE OBJECTIVES:

  1. Evaluate the utility of dynamic susceptibility contrast (DSC) and diffusion weighted imaging (DWI) magnetic resonance imaging (MRI) techniques in defining time to progression in the setting of a large multi-institutional clinical trial.

  2. Test the concordance between site-determined MGMT methylation status and central laboratory determination of MGMT status in cases with local testing.

  3. Evaluate whether genetic or epigenetic alterations in deoxyribonucleic acid (DNA) repair or replication genes are associated with overall survival, progression-free survival, and objective tumor response.

  4. Test whether polymorphisms in MGMT, PARP1, or other DNA repair proteins, are associated with overall survival, progression-free survival, objective tumor response, or rates of grade 3 or higher adverse events.

OUTLINE: Patients are randomized to 1 of 2 treatment arms.

ARM I: Patients receive temozolomide orally (PO) once daily (QD) on days 1-5 and veliparib PO twice daily (BID) on days 1-7. Treatment repeats every 28 days for 6 cycles in the absence of disease progression (confirmed progression) or unacceptable toxicity.

ARM II: 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.

After completion of study treatment, patients are followed up every 3 months for 3 years, every 6 months for 2 years.

Study Design

Study Type:
Interventional
Actual Enrollment :
447 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Double (Participant, Investigator)
Primary Purpose:
Treatment
Official Title:
A Phase II/III Randomized Trial of Veliparib or Placebo in Combination With Adjuvant Temozolomide in Newly Diagnosed Glioblastoma With MGMT Promoter Hypermethylation
Actual Study Start Date :
Dec 15, 2014
Actual Primary Completion Date :
Dec 1, 2021
Anticipated Study Completion Date :
Dec 15, 2022

Arms and Interventions

Arm Intervention/Treatment
Experimental: Arm I (temozolomide, veliparib)

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.

Other: Laboratory Biomarker Analysis
Correlative studies

Other: Quality-of-Life Assessment
Ancillary studies
Other Names:
  • Quality of Life Assessment

    • Drug: Temozolomide
    Given PO
    Other Names:
  • 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
  • Methazolastone
  • RP-46161
  • SCH 52365
  • Temcad
  • Temodal
  • Temodar
  • Temomedac
  • TMZ

    • Drug: Veliparib
    Given PO
    Other Names:
  • ABT-888
  • PARP-1 inhibitor ABT-888

    		•
    Placebo Comparator: Arm II (temozolomide, placebo)

    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.

    Other: Laboratory Biomarker Analysis
    Correlative studies

    Other: Placebo Administration
    Given PO

    Other: Quality-of-Life Assessment
    Ancillary studies
    Other Names:
  • Quality of Life Assessment

    • Drug: Temozolomide
    Given PO
    Other Names:
  • 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
  • Methazolastone
  • RP-46161
  • SCH 52365
  • Temcad
  • Temodal
  • Temodar
  • Temomedac
  • TMZ

    		•

    Outcome Measures

    Primary Outcome Measures

    1. Overall survival (OS) [From study registration to the date of death due to any cause, assessed up to 10 years]

      The distribution of OS for each arm will be estimated using the Kaplan-Meier method and compared with a stratified logrank test. Stratified Cox proportional hazard models will be used to estimate the hazard ratio for the treatment effect.

    Secondary Outcome Measures

    1. Interaction with Optune device [Up to 5 years]

      Cox proportional hazards model will be used to evaluate whether there is a potential interaction between the treatment arm and the Optune device. If an interaction is detected, separate analyses of treatment effect (using Cox models) will be done for patients treated with the Optune device and patients who were not treated with the Optune device.

    2. Progression-free survival (PFS) [From study registration to the date of first observation of disease progression or death due to any cause (whichever comes first), assessed up to 10 years]

      The distribution of PFS for each arm will be estimated using the Kaplan-Meier method, and be compared using Cox proportional hazard models with all stratification factors adjusted.

    3. Objective tumor response [Up to 5 years]

      Defined as complete response or partial response as specified in the Revised Assessment in Neuro-Oncology criteria. An objective tumor response will be evaluated for each patient and the tumor response rate will be summarized for each arm and compared using the Chi-square test.

    4. Overall adverse event rates for grade 3 or higher adverse events [Up to 5 years]

      Assessed using National Cancer Institute Common Terminology Criteria for Adverse Events version 4.0 (version 5 beginning April 1, 2018). The overall adverse event rates for grade 3 or higher adverse events will be summarized and be compared using Chi-Square or Fisher's Exact tests between treatment arms. The maximum grade for each type of treatment-related adverse event will be recorded for each patient, and frequency tables for each arm will be reviewed to determine patterns. Treatment-related adverse events will be tabulated for each arm.

    5. Change in quality of life (QOL) [Baseline to up to 5 years]

      Measured by the fatigue/uniscale tool. The fatigue/uniscale tool will be used as a measure of QOL. Potential differences in fatigue levels of patients treated on the two different arms will be evaluated. Changes in this measure will be evaluated over the course of treatment for both arms and will be compared using a two-sample t-test at each timepoint. Will also compute a normalized area under the curve (AUC) for the values of each patient over time and compare the mean AUCs for patients on the two arms.

    Other Outcome Measures

    1. MGMT status [Baseline]

      The concordance between site-determined MGMT methylation status and central laboratory determination of MGMT status will be analyzed using the Chi-Square test of proportions and 95% confidence intervals for the proportion of tests in disagreement with the local site.

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    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

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 University of Alabama at Birmingham Cancer Center Birmingham Alabama United States 35233
    2 Katmai Oncology Group Anchorage Alaska United States 99508
    3 Providence Alaska Medical Center Anchorage Alaska United States 99508
    4 Mayo Clinic in Arizona Scottsdale Arizona United States 85259
    5 Banner University Medical Center - Tucson Tucson Arizona United States 85719
    6 University of Arkansas for Medical Sciences Little Rock Arkansas United States 72205
    7 Kaiser Permanente-Deer Valley Medical Center Antioch California United States 94531
    8 Providence Saint Joseph Medical Center/Disney Family Cancer Center Burbank California United States 91505
    9 Mills-Peninsula Medical Center Burlingame California United States 94010
    10 John Muir Medical Center-Concord Campus Concord California United States 94520
    11 Kaiser Permanente-Fremont Fremont California United States 94538
    12 Fresno Cancer Center Fresno California United States 93720
    13 Kaiser Permanente-Fresno Fresno California United States 93720
    14 Saint Jude Medical Center Fullerton California United States 92835
    15 UC San Diego Moores Cancer Center La Jolla California United States 92093
    16 Kaiser Permanente Los Angeles Medical Center Los Angeles California United States 90027
    17 Los Angeles County-USC Medical Center Los Angeles California United States 90033
    18 USC / Norris Comprehensive Cancer Center Los Angeles California United States 90033
    19 Kaiser Permanente-Modesto Modesto California United States 95356
    20 USC Norris Oncology/Hematology-Newport Beach Newport Beach California United States 92663
    21 Kaiser Permanente Oakland-Broadway Oakland California United States 94611
    22 Kaiser Permanente-Oakland Oakland California United States 94611
    23 Saint Joseph Hospital - Orange Orange California United States 92868
    24 Kaiser Permanente-Rancho Cordova Cancer Center Rancho Cordova California United States 95670
    25 Kaiser Permanente-Redwood City Redwood City California United States 94063
    26 Kaiser Permanente-Richmond Richmond California United States 94801
    27 Rohnert Park Cancer Center Rohnert Park California United States 94928
    28 Kaiser Permanente-Roseville Roseville California United States 95661
    29 Sutter Roseville Medical Center Roseville California United States 95661
    30 The Permanente Medical Group-Roseville Radiation Oncology Roseville California United States 95678
    31 Sutter Medical Center Sacramento Sacramento California United States 95816
    32 University of California Davis Comprehensive Cancer Center Sacramento California United States 95817
    33 Kaiser Permanente-South Sacramento Sacramento California United States 95823
    34 South Sacramento Cancer Center Sacramento California United States 95823
    35 Kaiser Permanente - Sacramento Sacramento California United States 95825
    36 UC San Diego Medical Center - Hillcrest San Diego California United States 92103
    37 Kaiser Permanente-San Francisco San Francisco California United States 94115
    38 UCSF Medical Center-Parnassus San Francisco California United States 94143
    39 Kaiser Permanente-Santa Teresa-San Jose San Jose California United States 95119
    40 Kaiser Permanente San Leandro San Leandro California United States 94577
    41 Kaiser Permanente-San Rafael San Rafael California United States 94903
    42 Kaiser Permanente Medical Center - Santa Clara Santa Clara California United States 95051
    43 Palo Alto Medical Foundation-Santa Cruz Santa Cruz California United States 95065
    44 Kaiser Permanente-Santa Rosa Santa Rosa California United States 95403
    45 Kaiser Permanente Cancer Treatment Center South San Francisco California United States 94080
    46 Kaiser Permanente-South San Francisco South San Francisco California United States 94080
    47 Kaiser Permanente-Stockton Stockton California United States 95210
    48 Northbay Cancer Center Vacaville California United States 95687
    49 Kaiser Permanente Medical Center-Vacaville Vacaville California United States 95688
    50 Kaiser Permanente-Vallejo Vallejo California United States 94589
    51 Kaiser Permanente-Walnut Creek Walnut Creek California United States 94596
    52 John Muir Medical Center-Walnut Creek Walnut Creek California United States 94598
    53 University of Colorado Hospital Aurora Colorado United States 80045
    54 Boulder Community Hospital Boulder Colorado United States 80301
    55 Rocky Mountain Cancer Centers-Boulder Boulder Colorado United States 80304
    56 Penrose-Saint Francis Healthcare Colorado Springs Colorado United States 80907
    57 Rocky Mountain Cancer Centers-Penrose Colorado Springs Colorado United States 80907
    58 Kaiser Permanente-Franklin Denver Colorado United States 80205
    59 Swedish Medical Center Englewood Colorado United States 80113
    60 Poudre Valley Hospital Fort Collins Colorado United States 80524
    61 North Colorado Medical Center Greeley Colorado United States 80631
    62 Kaiser Permanente-Rock Creek Lafayette Colorado United States 80026
    63 Rocky Mountain Cancer Centers-Littleton Littleton Colorado United States 80120
    64 Littleton Adventist Hospital Littleton Colorado United States 80122
    65 Kaiser Permanente-Lone Tree Lone Tree Colorado United States 80124
    66 Rocky Mountain Cancer Centers-Longmont Longmont Colorado United States 80501
    67 McKee Medical Center Loveland Colorado United States 80539
    68 SCL Health Lutheran Medical Center Wheat Ridge Colorado United States 80033
    69 Hartford Hospital Hartford Connecticut United States 06102
    70 Smilow Cancer Hospital Care Center at Saint Francis Hartford Connecticut United States 06105
    71 Midstate Medical Center Meriden Connecticut United States 06451
    72 The Hospital of Central Connecticut New Britain Connecticut United States 06050
    73 Yale University New Haven Connecticut United States 06520
    74 Boca Raton Regional Hospital Boca Raton Florida United States 33486
    75 UM Sylvester Comprehensive Cancer Center at Deerfield Beach Deerfield Beach Florida United States 33442
    76 Memorial Regional Hospital/Joe DiMaggio Children's Hospital Hollywood Florida United States 33021
    77 Mayo Clinic in Florida Jacksonville Florida United States 32224-9980
    78 Lakeland Regional Health Hollis Cancer Center Lakeland Florida United States 33805
    79 Mount Sinai Medical Center Miami Beach Florida United States 33140
    80 University of Miami Miller School of Medicine-Sylvester Cancer Center Miami Florida United States 33136
    81 AdventHealth Orlando Orlando Florida United States 32803
    82 Orlando Health Cancer Institute Orlando Florida United States 32806
    83 Memorial Hospital West Pembroke Pines Florida United States 33028
    84 Moffitt Cancer Center Tampa Florida United States 33612
    85 Piedmont Hospital Atlanta Georgia United States 30309
    86 Emory University Hospital/Winship Cancer Institute Atlanta Georgia United States 30322
    87 Northside Hospital Atlanta Georgia United States 30342
    88 John B Amos Cancer Center Columbus Georgia United States 31904
    89 Northeast Georgia Medical Center-Gainesville Gainesville Georgia United States 30501
    90 Hawaii Cancer Care Inc - Waterfront Plaza Honolulu Hawaii United States 96813
    91 Queen's Cancer Cenrer - POB I Honolulu Hawaii United States 96813
    92 Queen's Medical Center Honolulu Hawaii United States 96813
    93 Straub Clinic and Hospital Honolulu Hawaii United States 96813
    94 Hawaii Cancer Care Inc-Liliha Honolulu Hawaii United States 96817
    95 Queen's Cancer Center - Kuakini Honolulu Hawaii United States 96817
    96 Saint Alphonsus Cancer Care Center-Boise Boise Idaho United States 83706
    97 Kootenai Clinic Cancer Services - Post Falls Post Falls Idaho United States 83854
    98 Saint Joseph Medical Center Bloomington Illinois United States 61701
    99 Northwestern University Chicago Illinois United States 60611
    100 Rush University Medical Center Chicago Illinois United States 60612
    101 Cancer Care Specialists of Illinois - Decatur Decatur Illinois United States 62526
    102 Decatur Memorial Hospital Decatur Illinois United States 62526
    103 Crossroads Cancer Center Effingham Illinois United States 62401
    104 NorthShore University HealthSystem-Evanston Hospital Evanston Illinois United States 60201
    105 Northwestern Medicine Cancer Center Delnor Geneva Illinois United States 60134
    106 NorthShore University HealthSystem-Glenbrook Hospital Glenview Illinois United States 60026
    107 NorthShore University HealthSystem-Highland Park Hospital Highland Park Illinois United States 60035
    108 Edward Hospital/Cancer Center Naperville Illinois United States 60540
    109 Advocate Lutheran General Hospital Park Ridge Illinois United States 60068
    110 Illinois CancerCare-Peoria Peoria Illinois United States 61615
    111 Methodist Medical Center of Illinois Peoria Illinois United States 61636
    112 OSF Saint Francis Medical Center Peoria Illinois United States 61637
    113 Edward Hospital/Cancer Center?Plainfield Plainfield Illinois United States 60585
    114 Central Illinois Hematology Oncology Center Springfield Illinois United States 62702
    115 Southern Illinois University School of Medicine Springfield Illinois United States 62702
    116 Memorial Medical Center Springfield Illinois United States 62781
    117 Carle Cancer Center Urbana Illinois United States 61801
    118 Northwestern Medicine Cancer Center Warrenville Warrenville Illinois United States 60555
    119 Parkview Hospital Randallia Fort Wayne Indiana United States 46805
    120 Franciscan Health Indianapolis Indianapolis Indiana United States 46237
    121 Reid Health Richmond Indiana United States 47374
    122 Memorial Hospital of South Bend South Bend Indiana United States 46601
    123 Physicians' Clinic of Iowa PC Cedar Rapids Iowa United States 52402
    124 Medical Oncology and Hematology Associates-West Des Moines Clive Iowa United States 50325
    125 Mercy Cancer Center-West Lakes Clive Iowa United States 50325
    126 Iowa Methodist Medical Center Des Moines Iowa United States 50309
    127 Medical Oncology and Hematology Associates-Laurel Des Moines Iowa United States 50314
    128 Mercy Medical Center - Des Moines Des Moines Iowa United States 50314
    129 Mercy Medical Center - North Iowa Mason City Iowa United States 50401
    130 Siouxland Regional Cancer Center Sioux City Iowa United States 51101
    131 Mercy Medical Center-West Lakes West Des Moines Iowa United States 50266
    132 Cancer Center of Kansas - Chanute Chanute Kansas United States 66720
    133 Cancer Center of Kansas - Dodge City Dodge City Kansas United States 67801
    134 Cancer Center of Kansas - El Dorado El Dorado Kansas United States 67042
    135 Cancer Center of Kansas - Fort Scott Fort Scott Kansas United States 66701
    136 Cancer Center of Kansas-Independence Independence Kansas United States 67301
    137 Cancer Center of Kansas-Kingman Kingman Kansas United States 67068
    138 Lawrence Memorial Hospital Lawrence Kansas United States 66044
    139 Cancer Center of Kansas-Liberal Liberal Kansas United States 67905
    140 Cancer Center of Kansas - McPherson McPherson Kansas United States 67460
    141 Cancer Center of Kansas - Newton Newton Kansas United States 67114
    142 Menorah Medical Center Overland Park Kansas United States 66209
    143 Cancer Center of Kansas - Parsons Parsons Kansas United States 67357
    144 Cancer Center of Kansas - Pratt Pratt Kansas United States 67124
    145 Cancer Center of Kansas - Salina Salina Kansas United States 67401
    146 Cancer Center of Kansas - Wellington Wellington Kansas United States 67152
    147 Cancer Center of Kansas-Wichita Medical Arts Tower Wichita Kansas United States 67208
    148 Ascension Via Christi Hospitals Wichita Wichita Kansas United States 67214
    149 Cancer Center of Kansas - Wichita Wichita Kansas United States 67214
    150 Cancer Center of Kansas - Winfield Winfield Kansas United States 67156
    151 Baptist Health Corbin Corbin Kentucky United States 40701
    152 Baptist Health Lexington Lexington Kentucky United States 40503
    153 University of Kentucky/Markey Cancer Center Lexington Kentucky United States 40536
    154 Baptist Health Louisville Louisville Kentucky United States 40207
    155 Baptist Health Madisonville/Merle Mahr Cancer Center Madisonville Kentucky United States 42431
    156 Baptist Health Paducah Paducah Kentucky United States 42003
    157 Mary Bird Perkins Cancer Center Baton Rouge Louisiana United States 70809
    158 The NeuroMedical Center-Clinic Baton Rouge Louisiana United States 70810
    159 Ochsner Medical Center Jefferson New Orleans Louisiana United States 70121
    160 Eastern Maine Medical Center Bangor Maine United States 04401
    161 Lafayette Family Cancer Center-EMMC Brewer Maine United States 04412
    162 Maine Center for Cancer Medicine-Scarborough Scarborough Maine United States 04074
    163 Maine Center for Cancer Medicine-Topsham Topsham Maine United States 04086
    164 Anne Arundel Medical Center Annapolis Maryland United States 21401
    165 Sinai Hospital of Baltimore Baltimore Maryland United States 21215
    166 Northwest Hospital Center Randallstown Maryland United States 21133
    167 TidalHealth Peninsula Regional Salisbury Maryland United States 21801
    168 Massachusetts General Hospital Cancer Center Boston Massachusetts United States 02114
    169 Dana-Farber Cancer Institute Boston Massachusetts United States 02215
    170 Simonds-Sinon Regional Cancer Center Fitchburg Massachusetts United States 01420
    171 Lowell General Hospital Lowell Massachusetts United States 01854
    172 UMass Memorial Medical Center - University Campus Worcester Massachusetts United States 01655
    173 Saint Joseph Mercy Hospital Ann Arbor Michigan United States 48106
    174 University of Michigan Comprehensive Cancer Center Ann Arbor Michigan United States 48109
    175 Ascension Saint John Hospital Detroit Michigan United States 48236
    176 Green Bay Oncology - Escanaba Escanaba Michigan United States 49829
    177 Genesys Hurley Cancer Institute Flint Michigan United States 48503
    178 Mercy Health Saint Mary's Grand Rapids Michigan United States 49503
    179 Spectrum Health at Butterworth Campus Grand Rapids Michigan United States 49503
    180 Green Bay Oncology - Iron Mountain Iron Mountain Michigan United States 49801
    181 West Michigan Cancer Center Kalamazoo Michigan United States 49007
    182 Sparrow Hospital Lansing Michigan United States 48912
    183 Trinity Health Saint Mary Mercy Livonia Hospital Livonia Michigan United States 48154
    184 Ascension Providence Hospitals - Novi Novi Michigan United States 48374
    185 Saint Joseph Mercy Oakland Pontiac Michigan United States 48341
    186 Spectrum Health Reed City Hospital Reed City Michigan United States 49677
    187 William Beaumont Hospital-Royal Oak Royal Oak Michigan United States 48073
    188 Ascension Saint Mary's Hospital Saginaw Michigan United States 48601
    189 Lakeland Medical Center Saint Joseph Saint Joseph Michigan United States 49085
    190 Marie Yeager Cancer Center Saint Joseph Michigan United States 49085
    191 Ascension Providence Hospitals - Southfield Southfield Michigan United States 48075
    192 Munson Medical Center Traverse City Michigan United States 49684
    193 Metro Health Hospital Wyoming Michigan United States 49519
    194 Sanford Joe Lueken Cancer Center Bemidji Minnesota United States 56601
    195 Mercy Hospital Coon Rapids Minnesota United States 55433
    196 Essentia Health Cancer Center Duluth Minnesota United States 55805
    197 Saint Luke's Hospital of Duluth Duluth Minnesota United States 55805
    198 Fairview Southdale Hospital Edina Minnesota United States 55435
    199 Abbott-Northwestern Hospital Minneapolis Minnesota United States 55407
    200 Hennepin County Medical Center Minneapolis Minnesota United States 55415
    201 Health Partners Inc Minneapolis Minnesota United States 55454
    202 North Memorial Medical Health Center Robbinsdale Minnesota United States 55422
    203 Mayo Clinic in Rochester Rochester Minnesota United States 55905
    204 Coborn Cancer Center at Saint Cloud Hospital Saint Cloud Minnesota United States 56303
    205 Regions Hospital Saint Paul Minnesota United States 55101
    206 United Hospital Saint Paul Minnesota United States 55102
    207 Rice Memorial Hospital Willmar Minnesota United States 56201
    208 Minnesota Oncology Hematology PA-Woodbury Woodbury Minnesota United States 55125
    209 University of Mississippi Medical Center Jackson Mississippi United States 39216
    210 Southeast Cancer Center Cape Girardeau Missouri United States 63703
    211 Saint Luke's Hospital Chesterfield Missouri United States 63017
    212 Centerpoint Medical Center LLC Independence Missouri United States 64057
    213 Saint Luke's Hospital of Kansas City Kansas City Missouri United States 64111
    214 Saint Luke's East - Lee's Summit Lee's Summit Missouri United States 64086
    215 Washington University School of Medicine Saint Louis Missouri United States 63110
    216 Missouri Baptist Medical Center Saint Louis Missouri United States 63131
    217 Mercy Hospital Saint Louis Saint Louis Missouri United States 63141
    218 Mercy Hospital Springfield Springfield Missouri United States 65804
    219 CoxHealth South Hospital Springfield Missouri United States 65807
    220 Billings Clinic Cancer Center Billings Montana United States 59101
    221 Bozeman Deaconess Hospital Bozeman Montana United States 59715
    222 Benefis Healthcare- Sletten Cancer Institute Great Falls Montana United States 59405
    223 CHI Health Saint Francis Grand Island Nebraska United States 68803
    224 CHI Health Good Samaritan Kearney Nebraska United States 68847
    225 Faith Regional Health Services Carson Cancer Center Norfolk Nebraska United States 68701
    226 Nebraska Methodist Hospital Omaha Nebraska United States 68114
    227 Alegent Health Immanuel Medical Center Omaha Nebraska United States 68122
    228 Alegent Health Bergan Mercy Medical Center Omaha Nebraska United States 68124
    229 Nebraska Cancer Specialists - Omaha Omaha Nebraska United States 68124
    230 Creighton University Medical Center Omaha Nebraska United States 68131
    231 University of Nebraska Medical Center Omaha Nebraska United States 68198
    232 Renown Regional Medical Center Reno Nevada United States 89502
    233 New Hampshire Oncology Hematology PA-Concord Concord New Hampshire United States 03301
    234 Dartmouth Hitchcock Medical Center Lebanon New Hampshire United States 03756
    235 Solinsky Center for Cancer Care Manchester New Hampshire United States 03103
    236 Portsmouth Regional Hospital Portsmouth New Hampshire United States 03802
    237 John F Kennedy Medical Center Edison New Jersey United States 08818
    238 Hackensack University Medical Center Hackensack New Jersey United States 07601
    239 Saint Barnabas Medical Center Livingston New Jersey United States 07039
    240 Rutgers Cancer Institute of New Jersey-Robert Wood Johnson University Hospital New Brunswick New Jersey United States 08903
    241 Rutgers Cancer Institute of New Jersey New Brunswick New Jersey United States 08903
    242 The Valley Hospital-Luckow Pavilion Paramus New Jersey United States 07652
    243 Valley Hospital Ridgewood New Jersey United States 07450
    244 Overlook Hospital Summit New Jersey United States 07902
    245 Valley Health System-Hematology/Oncology Westwood New Jersey United States 07675
    246 Montefiore Medical Center - Moses Campus Bronx New York United States 10467
    247 Roswell Park Cancer Institute Buffalo New York United States 14263
    248 Mary Imogene Bassett Hospital Cooperstown New York United States 13326
    249 Mount Sinai Hospital New York New York United States 10029
    250 University of Rochester Rochester New York United States 14642
    251 State University of New York Upstate Medical University Syracuse New York United States 13210
    252 Mission Hospital Asheville North Carolina United States 28801
    253 UNC Lineberger Comprehensive Cancer Center Chapel Hill North Carolina United States 27599
    254 East Carolina University Greenville North Carolina United States 27834
    255 Vidant Oncology-Kinston Kinston North Carolina United States 28501
    256 Wake Forest University Health Sciences Winston-Salem North Carolina United States 27157
    257 Sanford Broadway Medical Center Fargo North Dakota United States 58122
    258 Sanford Clinic North-Fargo Fargo North Dakota United States 58122
    259 Sanford Roger Maris Cancer Center Fargo North Dakota United States 58122
    260 Altru Cancer Center Grand Forks North Dakota United States 58201
    261 Cleveland Clinic Akron General Akron Ohio United States 44307
    262 Cleveland Clinic Mercy Hospital Canton Ohio United States 44708
    263 Adena Regional Medical Center Chillicothe Ohio United States 45601
    264 University of Cincinnati Cancer Center-UC Medical Center Cincinnati Ohio United States 45219
    265 Cleveland Clinic Foundation Cleveland Ohio United States 44195
    266 Ohio State University Comprehensive Cancer Center Columbus Ohio United States 43210
    267 Mount Carmel East Hospital Columbus Ohio United States 43213
    268 Riverside Methodist Hospital Columbus Ohio United States 43214
    269 Grant Medical Center Columbus Ohio United States 43215
    270 Good Samaritan Hospital - Dayton Dayton Ohio United States 45406
    271 Miami Valley Hospital Dayton Ohio United States 45409
    272 Dayton Physician LLC-Miami Valley Hospital North Dayton Ohio United States 45415
    273 Miami Valley Hospital North Dayton Ohio United States 45415
    274 Armes Family Cancer Center Findlay Ohio United States 45840
    275 Blanchard Valley Hospital Findlay Ohio United States 45840
    276 Orion Cancer Care Findlay Ohio United States 45840
    277 Wayne Hospital Greenville Ohio United States 45331
    278 Toledo Clinic Cancer Centers-Maumee Maumee Ohio United States 43537
    279 Saint Charles Hospital Oregon Ohio United States 43616
    280 Mercy Health Perrysburg Cancer Center Perrysburg Ohio United States 43551
    281 ProMedica Flower Hospital Sylvania Ohio United States 43560
    282 Mercy Health - Saint Anne Hospital Toledo Ohio United States 43623
    283 Toledo Clinic Cancer Centers-Toledo Toledo Ohio United States 43623
    284 University of Cincinnati Cancer Center-West Chester West Chester Ohio United States 45069
    285 University of Oklahoma Health Sciences Center Oklahoma City Oklahoma United States 73104
    286 Oklahoma Cancer Specialists and Research Institute-Tulsa Tulsa Oklahoma United States 74146
    287 Legacy Good Samaritan Hospital and Medical Center Portland Oregon United States 97210
    288 Providence Portland Medical Center Portland Oregon United States 97213
    289 Providence Saint Vincent Medical Center Portland Oregon United States 97225
    290 Kaiser Permanente Northwest Portland Oregon United States 97227
    291 Jefferson Abington Hospital Abington Pennsylvania United States 19001
    292 Lehigh Valley Hospital-Cedar Crest Allentown Pennsylvania United States 18103
    293 Bryn Mawr Hospital Bryn Mawr Pennsylvania United States 19010
    294 Geisinger Medical Center Danville Pennsylvania United States 17822
    295 UPMC Pinnacle Cancer Center/Community Osteopathic Campus Harrisburg Pennsylvania United States 17109
    296 Lancaster General Hospital Lancaster Pennsylvania United States 17602
    297 Paoli Memorial Hospital Paoli Pennsylvania United States 19301
    298 Allegheny General Hospital Pittsburgh Pennsylvania United States 15212
    299 University of Pittsburgh Cancer Institute (UPCI) Pittsburgh Pennsylvania United States 15232
    300 Guthrie Medical Group PC-Robert Packer Hospital Sayre Pennsylvania United States 18840
    301 Geisinger Wyoming Valley/Henry Cancer Center Wilkes-Barre Pennsylvania United States 18711
    302 UPMC Susquehanna Williamsport Pennsylvania United States 17701
    303 Lankenau Medical Center Wynnewood Pennsylvania United States 19096
    304 Rhode Island Hospital Providence Rhode Island United States 02903
    305 Prisma Health Cancer Institute - Spartanburg Boiling Springs South Carolina United States 29316
    306 Roper Hospital Charleston South Carolina United States 29401
    307 Charleston Oncology - Roper Charleston South Carolina United States 29403
    308 Lowcountry Hematology Oncology PA-North Charleston Charleston South Carolina United States 29406
    309 Bon Secours Saint Francis Hospital Charleston South Carolina United States 29414
    310 Charleston Oncology - Saint Francis Charleston South Carolina United States 29414
    311 Lowcountry Hematology Oncology PA-West Ashley Charleston South Carolina United States 29414
    312 Medical University of South Carolina Charleston South Carolina United States 29425
    313 Prisma Health Cancer Institute - Easley Easley South Carolina United States 29640
    314 Gibbs Cancer Center-Gaffney Gaffney South Carolina United States 29341
    315 Greenville Health System Cancer Institute-Andrews Greenville South Carolina United States 29601
    316 Saint Francis Hospital Greenville South Carolina United States 29601
    317 Prisma Health Cancer Institute - Butternut Greenville South Carolina United States 29605
    318 Prisma Health Cancer Institute - Faris Greenville South Carolina United States 29605
    319 Prisma Health Greenville Memorial Hospital Greenville South Carolina United States 29605
    320 Saint Francis Cancer Center Greenville South Carolina United States 29607
    321 Prisma Health Cancer Institute - Eastside Greenville South Carolina United States 29615
    322 Prisma Health Cancer Institute - Greer Greer South Carolina United States 29650
    323 Gibbs Cancer Center-Pelham Greer South Carolina United States 29651
    324 Lowcountry Hematology Oncology PA-Mount Pleasant Mount Pleasant South Carolina United States 29464
    325 Prisma Health Cancer Institute - Seneca Seneca South Carolina United States 29672
    326 Spartanburg Medical Center Spartanburg South Carolina United States 29303
    327 Avera Cancer Institute-Aberdeen Aberdeen South Dakota United States 57401
    328 Rapid City Regional Hospital Rapid City South Dakota United States 57701
    329 Sanford Cancer Center Oncology Clinic Sioux Falls South Dakota United States 57104
    330 Avera Cancer Institute Sioux Falls South Dakota United States 57105
    331 Sanford USD Medical Center - Sioux Falls Sioux Falls South Dakota United States 57117-5134
    332 Wellmont Holston Valley Hospital and Medical Center Kingsport Tennessee United States 37660
    333 University of Tennessee - Knoxville Knoxville Tennessee United States 37920
    334 Vanderbilt University/Ingram Cancer Center Nashville Tennessee United States 37232
    335 UT Southwestern/Simmons Cancer Center-Dallas Dallas Texas United States 75390
    336 Brooke Army Medical Center Fort Sam Houston Texas United States 78234
    337 Baylor College of Medicine/Dan L Duncan Comprehensive Cancer Center Houston Texas United States 77030
    338 Ben Taub General Hospital Houston Texas United States 77030
    339 M D Anderson Cancer Center Houston Texas United States 77030
    340 Memorial Hermann Texas Medical Center Houston Texas United States 77030
    341 Huntsman Cancer Institute/University of Utah Salt Lake City Utah United States 84112
    342 University of Vermont and State Agricultural College Burlington Vermont United States 05405
    343 University of Virginia Cancer Center Charlottesville Virginia United States 22908
    344 Danville Regional Medical Center Danville Virginia United States 24541
    345 Inova Fairfax Hospital Falls Church Virginia United States 22042
    346 MultiCare Auburn Medical Center Auburn Washington United States 98001
    347 PeaceHealth Saint Joseph Medical Center Bellingham Washington United States 98225
    348 Highline Medical Center-Main Campus Burien Washington United States 98166
    349 MultiCare Gig Harbor Medical Park Gig Harbor Washington United States 98335
    350 Jefferson Healthcare Port Townsend Washington United States 98368
    351 MultiCare Good Samaritan Hospital Puyallup Washington United States 98372
    352 Virginia Mason Medical Center Seattle Washington United States 98101
    353 Franciscan Research Center-Northwest Medical Plaza Tacoma Washington United States 98405
    354 MultiCare Tacoma General Hospital Tacoma Washington United States 98405
    355 Northwest Medical Specialties PLLC Tacoma Washington United States 98405
    356 PeaceHealth Southwest Medical Center Vancouver Washington United States 98664
    357 Edwards Comprehensive Cancer Center Huntington West Virginia United States 25701
    358 West Virginia University Healthcare Morgantown West Virginia United States 26506
    359 Aurora Cancer Care-Southern Lakes VLCC Burlington Wisconsin United States 53105
    360 HSHS Sacred Heart Hospital Eau Claire Wisconsin United States 54701
    361 Marshfield Clinic Cancer Center at Sacred Heart Eau Claire Wisconsin United States 54701
    362 Aurora Health Center-Fond du Lac Fond Du Lac Wisconsin United States 54937
    363 Aurora Health Care Germantown Health Center Germantown Wisconsin United States 53022
    364 Aurora Cancer Care-Grafton Grafton Wisconsin United States 53024
    365 Green Bay Oncology at Saint Vincent Hospital Green Bay Wisconsin United States 54301-3526
    366 Saint Vincent Hospital Cancer Center Green Bay Green Bay Wisconsin United States 54301
    367 Green Bay Oncology Limited at Saint Mary's Hospital Green Bay Wisconsin United States 54303
    368 Saint Vincent Hospital Cancer Center at Saint Mary's Green Bay Wisconsin United States 54303
    369 Aurora BayCare Medical Center Green Bay Wisconsin United States 54311
    370 Mercyhealth Hospital and Cancer Center - Janesville Janesville Wisconsin United States 53548
    371 Gundersen Lutheran Medical Center La Crosse Wisconsin United States 54601
    372 University of Wisconsin Carbone Cancer Center Madison Wisconsin United States 53792
    373 Aurora Bay Area Medical Group-Marinette Marinette Wisconsin United States 54143
    374 Marshfield Medical Center-Marshfield Marshfield Wisconsin United States 54449
    375 Marshfield Medical Center Marshfield Wisconsin United States 54449
    376 Aurora Cancer Care-Milwaukee Milwaukee Wisconsin United States 53209
    377 Aurora Saint Luke's Medical Center Milwaukee Wisconsin United States 53215
    378 Medical College of Wisconsin Milwaukee Wisconsin United States 53226
    379 Aurora Sinai Medical Center Milwaukee Wisconsin United States 53233
    380 Marshfield Clinic-Minocqua Center Minocqua Wisconsin United States 54548
    381 ProHealth D N Greenwald Center Mukwonago Wisconsin United States 53149
    382 ProHealth Oconomowoc Memorial Hospital Oconomowoc Wisconsin United States 53066
    383 Saint Vincent Hospital Cancer Center at Oconto Falls Oconto Falls Wisconsin United States 54154
    384 Vince Lombardi Cancer Clinic - Oshkosh Oshkosh Wisconsin United States 54904
    385 Aurora Cancer Care-Racine Racine Wisconsin United States 53406
    386 Lakeview Medical Center-Marshfield Clinic Rice Lake Wisconsin United States 54868
    387 Marshfield Medical Center-Rice Lake Rice Lake Wisconsin United States 54868
    388 Vince Lombardi Cancer Clinic-Sheboygan Sheboygan Wisconsin United States 53081
    389 Saint Vincent Hospital Cancer Center at Sturgeon Bay Sturgeon Bay Wisconsin United States 54235-1495
    390 Green Bay Oncology - Sturgeon Bay Sturgeon Bay Wisconsin United States 54235
    391 Aurora Medical Center in Summit Summit Wisconsin United States 53066
    392 Vince Lombardi Cancer Clinic-Two Rivers Two Rivers Wisconsin United States 54241
    393 Aurora Cancer Care-Waukesha Waukesha Wisconsin United States 53188
    394 ProHealth Waukesha Memorial Hospital Waukesha Wisconsin United States 53188
    395 UW Cancer Center at ProHealth Care Waukesha Wisconsin United States 53188
    396 Aurora Cancer Care-Milwaukee West Wauwatosa Wisconsin United States 53226
    397 Aurora West Allis Medical Center West Allis Wisconsin United States 53227
    398 Diagnostic and Treatment Center Weston Wisconsin United States 54476
    399 Marshfield Medical Center - Weston Weston Wisconsin United States 54476
    400 Fundacion De Investigacion de Diego San Juan Puerto Rico 00927

    Sponsors and Collaborators

    • National Cancer Institute (NCI)

    Investigators

    • Principal Investigator: Jann N Sarkaria, Alliance for Clinical Trials in Oncology

    Study Documents (Full-Text)

    More Information

    Publications

    None provided.
    Responsible Party:
    National Cancer Institute (NCI)
    ClinicalTrials.gov Identifier:
    NCT02152982
    Other Study ID Numbers:
    • NCI-2014-00616
    • NCI-2014-00616
    • A071102
    • CALGB-A071102
    • A071102
    • A071102
    • P50CA108961
    • U10CA180821
    • U10CA031946
    First Posted:
    Jun 2, 2014
    Last Update Posted:
    Jul 28, 2022
    Last Verified:
    Jun 1, 2022
    Additional relevant MeSH terms:
    Glioblastoma
    Gliosarcoma
    Temozolomide
    Veliparib

    Study Results

    No Results Posted as of Jul 28, 2022