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Trial record 1 of 1 for:    A071102
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Temozolomide With or Without Veliparib in Treating Patients With Newly Diagnosed Glioblastoma Multiforme

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ClinicalTrials.gov Identifier: NCT02152982
Recruitment Status : Active, not recruiting
First Posted : June 2, 2014
Last Update Posted : August 2, 2018
Sponsor:
Information provided by (Responsible Party):
National Cancer Institute (NCI)

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
Glioblastoma Gliosarcoma Other: Laboratory Biomarker Analysis Other: Placebo Other: Quality-of-Life Assessment Drug: Temozolomide Drug: Veliparib Phase 2 Phase 3

Detailed Description:

PRIMARY OBJECTIVES:

I. 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:

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

II. 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.

TERTIARY OBJECTIVES:

I. 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.

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

III. 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.

IV. 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 courses 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 courses 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 Type : Interventional  (Clinical Trial)
Estimated Enrollment : 440 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 : December 15, 2014
Estimated Primary Completion Date : June 30, 2022

Resource links provided by the National Library of Medicine


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 courses 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 Name: 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

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 courses in the absence of disease progression (confirmed progression) or unacceptable toxicity.
Other: Laboratory Biomarker Analysis
Correlative studies

Other: Placebo
Given PO
Other Names:
  • placebo therapy
  • PLCB
  • sham therapy

Other: Quality-of-Life Assessment
Ancillary studies
Other Name: 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




Primary Outcome Measures :
  1. Overall survival (OS) [ Time Frame: 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 [ Time Frame: 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) [ Time Frame: 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, defined as complete response or partial response as specified in the Revised Assessment in Neuro-Oncology criteria [ Time Frame: Up to 5 years ]
    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 assessed using National Cancer Institute Common Terminology Criteria for Adverse Events version 4.0 (version 5 beginning April 1, 2018) [ Time Frame: Up to 5 years ]
    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), measured by the fatigue/uniscale tool [ Time Frame: Baseline to up to 5 years ]
    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 [ Time Frame: 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.



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02152982


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Locations
United States, Alabama
University of Alabama at Birmingham Cancer Center
Birmingham, Alabama, United States, 35233
United States, Alaska
Katmai Oncology Group
Anchorage, Alaska, United States, 99508
Providence Alaska Medical Center
Anchorage, Alaska, United States, 99508
United States, Arizona
Mayo Clinic in Arizona
Scottsdale, Arizona, United States, 85259
The University of Arizona Medical Center-University Campus
Tucson, Arizona, United States, 85724
United States, Arkansas
University of Arkansas for Medical Sciences
Little Rock, Arkansas, United States, 72205
United States, California
Kaiser Permanente-Deer Valley Medical Center
Antioch, California, United States, 94531
Providence Saint Joseph Medical Center/Disney Family Cancer Center
Burbank, California, United States, 91505
Mills-Peninsula Medical Center
Burlingame, California, United States, 94010
John Muir Medical Center-Concord Campus
Concord, California, United States, 94520
Kaiser Permanente-Fremont
Fremont, California, United States, 94538
Fresno Cancer Center
Fresno, California, United States, 93720
Kaiser Permanente-Fresno
Fresno, California, United States, 93720
Saint Jude Medical Center
Fullerton, California, United States, 92835
UC San Diego Moores Cancer Center
La Jolla, California, United States, 92093
Kaiser Permanente Los Angeles Medical Center
Los Angeles, California, United States, 90027
Los Angeles County-USC Medical Center
Los Angeles, California, United States, 90033
USC / Norris Comprehensive Cancer Center
Los Angeles, California, United States, 90033
Kaiser Permanente-Modesto
Modesto, California, United States, 95356
USC Norris Oncology/Hematology-Newport Beach
Newport Beach, California, United States, 92663
Kaiser Permanente Oakland-Broadway
Oakland, California, United States, 94611
Kaiser Permanente-Oakland
Oakland, California, United States, 94611
Saint Joseph Hospital - Orange
Orange, California, United States, 92868
Kaiser Permanente-Rancho Cordova Cancer Center
Rancho Cordova, California, United States, 95670
Kaiser Permanente-Redwood City
Redwood City, California, United States, 94063
Kaiser Permanente-Richmond
Richmond, California, United States, 94801
Rohnert Park Cancer Center
Rohnert Park, California, United States, 94928
Kaiser Permanente-Roseville
Roseville, California, United States, 95661
Sutter Roseville Medical Center
Roseville, California, United States, 95661
The Permanente Medical Group-Roseville Radiation Oncology
Roseville, California, United States, 95678
Sutter Medical Center Sacramento
Sacramento, California, United States, 95816
University of California Davis Comprehensive Cancer Center
Sacramento, California, United States, 95817
Kaiser Permanente-South Sacramento
Sacramento, California, United States, 95823
South Sacramento Cancer Center
Sacramento, California, United States, 95823
Kaiser Permanente - Sacramento
Sacramento, California, United States, 95825
University of California San Diego
San Diego, California, United States, 92103
Kaiser Permanente-San Francisco
San Francisco, California, United States, 94115
UCSF Medical Center-Parnassus
San Francisco, California, United States, 94143
Kaiser Permanente-Santa Teresa-San Jose
San Jose, California, United States, 95119
Kaiser Permanente San Leandro
San Leandro, California, United States, 94577
Kaiser Permanente-San Rafael
San Rafael, California, United States, 94903
Kaiser Permanente Medical Center - Santa Clara
Santa Clara, California, United States, 95051
Palo Alto Medical Foundation-Santa Cruz
Santa Cruz, California, United States, 95065
Kaiser Permanente-Santa Rosa
Santa Rosa, California, United States, 95403
Kaiser Permanente Cancer Treatment Center
South San Francisco, California, United States, 94080
Kaiser Permanente-South San Francisco
South San Francisco, California, United States, 94080
Kaiser Permanente-Stockton
Stockton, California, United States, 95210
Northbay Cancer Center
Vacaville, California, United States, 95687
Kaiser Permanente Medical Center-Vacaville
Vacaville, California, United States, 95688
Kaiser Permanente-Vallejo
Vallejo, California, United States, 94589
Kaiser Permanente-Walnut Creek
Walnut Creek, California, United States, 94596
John Muir Medical Center-Walnut Creek
Walnut Creek, California, United States, 94598
United States, Colorado
University of Colorado Hospital
Aurora, Colorado, United States, 80045
Boulder Community Hospital
Boulder, Colorado, United States, 80301
Rocky Mountain Cancer Centers-Boulder
Boulder, Colorado, United States, 80304
Penrose-Saint Francis Healthcare
Colorado Springs, Colorado, United States, 80907
Rocky Mountain Cancer Centers-Penrose
Colorado Springs, Colorado, United States, 80907
Kaiser Permanente-Franklin
Denver, Colorado, United States, 80205
Swedish Medical Center
Englewood, Colorado, United States, 80113
Poudre Valley Hospital
Fort Collins, Colorado, United States, 80524
North Colorado Medical Center
Greeley, Colorado, United States, 80631
Kaiser Permanente-Rock Creek
Lafayette, Colorado, United States, 80026
Rocky Mountain Cancer Centers-Littleton
Littleton, Colorado, United States, 80120
Littleton Adventist Hospital
Littleton, Colorado, United States, 80122
Kaiser Permanente-Lone Tree
Lone Tree, Colorado, United States, 80124
Rocky Mountain Cancer Centers-Longmont
Longmont, Colorado, United States, 80501
McKee Medical Center
Loveland, Colorado, United States, 80539
SCL Health Lutheran Medical Center
Wheat Ridge, Colorado, United States, 80033
United States, Connecticut
Hartford Hospital
Hartford, Connecticut, United States, 06102
Smilow Cancer Hospital Care Center at Saint Francis
Hartford, Connecticut, United States, 06105
Midstate Medical Center
Meriden, Connecticut, United States, 06451
The Hospital of Central Connecticut
New Britain, Connecticut, United States, 06050
Yale University
New Haven, Connecticut, United States, 06520
United States, Florida
Boca Raton Regional Hospital
Boca Raton, Florida, United States, 33486
UM Sylvester Comprehensive Cancer Center at Deerfield Beach
Deerfield Beach, Florida, United States, 33442
Memorial Regional Hospital/Joe DiMaggio Children's Hospital
Hollywood, Florida, United States, 33021
Mayo Clinic in Florida
Jacksonville, Florida, United States, 32224-9980
Lakeland Regional Health Hollis Cancer Center
Lakeland, Florida, United States, 33805
Mount Sinai Medical Center
Miami Beach, Florida, United States, 33140
University of Miami Miller School of Medicine-Sylvester Cancer Center
Miami, Florida, United States, 33136
Florida Hospital Orlando
Orlando, Florida, United States, 32803
UF Cancer Center at Orlando Health
Orlando, Florida, United States, 32806
Memorial Hospital West
Pembroke Pines, Florida, United States, 33028
Moffitt Cancer Center
Tampa, Florida, United States, 33612
United States, Georgia
Piedmont Hospital
Atlanta, Georgia, United States, 30309
Emory University Hospital/Winship Cancer Institute
Atlanta, Georgia, United States, 30322
Northside Hospital
Atlanta, Georgia, United States, 30342
John B Amos Cancer Center
Columbus, Georgia, United States, 31904
Northeast Georgia Medical Center-Gainesville
Gainesville, Georgia, United States, 30501
United States, Hawaii
Hawaii Cancer Care Inc-POB II
Honolulu, Hawaii, United States, 96813
Hawaii Oncology Inc-POB I
Honolulu, Hawaii, United States, 96813
Queen's Medical Center
Honolulu, Hawaii, United States, 96813
Straub Clinic and Hospital
Honolulu, Hawaii, United States, 96813
Hawaii Cancer Care Inc-Liliha
Honolulu, Hawaii, United States, 96817
Hawaii Oncology Inc-Kuakini
Honolulu, Hawaii, United States, 96817
United States, Idaho
Saint Alphonsus Cancer Care Center-Boise
Boise, Idaho, United States, 83706
Kootenai Cancer Center
Post Falls, Idaho, United States, 83854
United States, Illinois
Saint Joseph Medical Center
Bloomington, Illinois, United States, 61701
Northwestern University
Chicago, Illinois, United States, 60611
Rush University Medical Center
Chicago, Illinois, United States, 60612
Cancer Care Specialists of Illinois - Decatur
Decatur, Illinois, United States, 62526
Decatur Memorial Hospital
Decatur, Illinois, United States, 62526
Crossroads Cancer Center
Effingham, Illinois, United States, 62401
NorthShore University HealthSystem-Evanston Hospital
Evanston, Illinois, United States, 60201
Northwestern Medicine Cancer Center Delnor
Geneva, Illinois, United States, 60134
NorthShore University HealthSystem-Glenbrook Hospital
Glenview, Illinois, United States, 60026
NorthShore University HealthSystem-Highland Park Hospital
Highland Park, Illinois, United States, 60035
Edward Hospital/Cancer Center
Naperville, Illinois, United States, 60540
Advocate Lutheran General Hospital
Park Ridge, Illinois, United States, 60068
Illinois CancerCare-Peoria
Peoria, Illinois, United States, 61615
Methodist Medical Center of Illinois
Peoria, Illinois, United States, 61636
OSF Saint Francis Medical Center
Peoria, Illinois, United States, 61637
Edward Hospital/Cancer Center?Plainfield
Plainfield, Illinois, United States, 60585
Central Illinois Hematology Oncology Center
Springfield, Illinois, United States, 62702
Southern Illinois University School of Medicine
Springfield, Illinois, United States, 62702
Memorial Medical Center
Springfield, Illinois, United States, 62781
Carle Cancer Center
Urbana, Illinois, United States, 61801
Northwestern Medicine Cancer Center Warrenville
Warrenville, Illinois, United States, 60555
United States, Indiana
Parkview Hospital Randallia
Fort Wayne, Indiana, United States, 46805
Franciscan Health Indianapolis
Indianapolis, Indiana, United States, 46237
Reid Health
Richmond, Indiana, United States, 47374
Memorial Hospital of South Bend
South Bend, Indiana, United States, 46601
United States, Iowa
Physicians' Clinic of Iowa PC
Cedar Rapids, Iowa, United States, 52402
Medical Oncology and Hematology Associates-West Des Moines
Clive, Iowa, United States, 50325
Mercy Cancer Center-West Lakes
Clive, Iowa, United States, 50325
Iowa Methodist Medical Center
Des Moines, Iowa, United States, 50309
Medical Oncology and Hematology Associates-Laurel
Des Moines, Iowa, United States, 50314
Mercy Medical Center - Des Moines
Des Moines, Iowa, United States, 50314
Mercy Medical Center - North Iowa
Mason City, Iowa, United States, 50401
Siouxland Regional Cancer Center
Sioux City, Iowa, United States, 51101
Mercy Medical Center-West Lakes
West Des Moines, Iowa, United States, 50266
United States, Kansas
Cancer Center of Kansas - Chanute
Chanute, Kansas, United States, 66720
Cancer Center of Kansas - Dodge City
Dodge City, Kansas, United States, 67801
Cancer Center of Kansas - El Dorado
El Dorado, Kansas, United States, 67042
Cancer Center of Kansas - Fort Scott
Fort Scott, Kansas, United States, 66701
Cancer Center of Kansas-Independence
Independence, Kansas, United States, 67301
Cancer Center of Kansas-Kingman
Kingman, Kansas, United States, 67068
Lawrence Memorial Hospital
Lawrence, Kansas, United States, 66044
Cancer Center of Kansas-Liberal
Liberal, Kansas, United States, 67905
Cancer Center of Kansas - McPherson
McPherson, Kansas, United States, 67460
Cancer Center of Kansas - Newton
Newton, Kansas, United States, 67114
Menorah Medical Center
Overland Park, Kansas, United States, 66209
Cancer Center of Kansas - Parsons
Parsons, Kansas, United States, 67357
Cancer Center of Kansas - Pratt
Pratt, Kansas, United States, 67124
Cancer Center of Kansas - Salina
Salina, Kansas, United States, 67401
Cancer Center of Kansas - Wellington
Wellington, Kansas, United States, 67152
Cancer Center of Kansas-Wichita Medical Arts Tower
Wichita, Kansas, United States, 67208
Cancer Center of Kansas - Wichita
Wichita, Kansas, United States, 67214
Via Christi Regional Medical Center
Wichita, Kansas, United States, 67214
Cancer Center of Kansas - Winfield
Winfield, Kansas, United States, 67156
United States, Kentucky
Baptist Health Corbin
Corbin, Kentucky, United States, 40701
Baptist Health Lexington
Lexington, Kentucky, United States, 40503
University of Kentucky/Markey Cancer Center
Lexington, Kentucky, United States, 40536
Baptist Health Louisville
Louisville, Kentucky, United States, 40207
Baptist Health Madisonville/Merle Mahr Cancer Center
Madisonville, Kentucky, United States, 42431
Baptist Health Paducah
Paducah, Kentucky, United States, 42003
United States, Louisiana
Mary Bird Perkins Cancer Center
Baton Rouge, Louisiana, United States, 70809
The NeuroMedical Center-Clinic
Baton Rouge, Louisiana, United States, 70810
Ochsner Medical Center Jefferson
New Orleans, Louisiana, United States, 70121
United States, Maine
Eastern Maine Medical Center
Bangor, Maine, United States, 04401
Lafayette Family Cancer Center-EMMC
Brewer, Maine, United States, 04412
Maine Center for Cancer Medicine-Scarborough
Scarborough, Maine, United States, 04074
Maine Center for Cancer Medicine-Topsham
Topsham, Maine, United States, 04086
United States, Maryland
Anne Arundel Medical Center
Annapolis, Maryland, United States, 21401
Sinai Hospital of Baltimore
Baltimore, Maryland, United States, 21215
Northwest Hospital Center
Randallstown, Maryland, United States, 21133
Peninsula Regional Medical Center
Salisbury, Maryland, United States, 21801
United States, Massachusetts
Massachusetts General Hospital Cancer Center
Boston, Massachusetts, United States, 02114
Dana-Farber Cancer Institute
Boston, Massachusetts, United States, 02215
Simonds-Sinon Regional Cancer Center
Fitchburg, Massachusetts, United States, 01420
Lowell General Hospital
Lowell, Massachusetts, United States, 01854
University of Massachusetts Medical School
Worcester, Massachusetts, United States, 01655
United States, Michigan
Saint Joseph Mercy Hospital
Ann Arbor, Michigan, United States, 48106
University of Michigan Comprehensive Cancer Center
Ann Arbor, Michigan, United States, 48109
Saint John Hospital and Medical Center
Detroit, Michigan, United States, 48236
Green Bay Oncology - Escanaba
Escanaba, Michigan, United States, 49829
Genesys Hurley Cancer Institute
Flint, Michigan, United States, 48503
Mercy Health Saint Mary's
Grand Rapids, Michigan, United States, 49503
Spectrum Health at Butterworth Campus
Grand Rapids, Michigan, United States, 49503
Green Bay Oncology - Iron Mountain
Iron Mountain, Michigan, United States, 49801
West Michigan Cancer Center
Kalamazoo, Michigan, United States, 49007
Sparrow Hospital
Lansing, Michigan, United States, 48912
Saint Mary Mercy Hospital
Livonia, Michigan, United States, 48154
Assarian Cancer Center
Novi, Michigan, United States, 48374-1236
Saint Joseph Mercy Oakland
Pontiac, Michigan, United States, 48341
Spectrum Health Reed City Hospital
Reed City, Michigan, United States, 49677
William Beaumont Hospital-Royal Oak
Royal Oak, Michigan, United States, 48073
Saint Mary's of Michigan
Saginaw, Michigan, United States, 48601
Lakeland Medical Center Saint Joseph
Saint Joseph, Michigan, United States, 49085
Marie Yeager Cancer Center
Saint Joseph, Michigan, United States, 49085
Providence Hospital-Southfield Cancer Center
Southfield, Michigan, United States, 48075
Munson Medical Center
Traverse City, Michigan, United States, 49684
Metro Health Hospital
Wyoming, Michigan, United States, 49519
United States, Minnesota
Sanford Clinic North-Bemidgi
Bemidji, Minnesota, United States, 56601
Mercy Hospital
Coon Rapids, Minnesota, United States, 55433
Essentia Health Cancer Center
Duluth, Minnesota, United States, 55805
Saint Luke's Hospital of Duluth
Duluth, Minnesota, United States, 55805
Fairview-Southdale Hospital
Edina, Minnesota, United States, 55435
Abbott-Northwestern Hospital
Minneapolis, Minnesota, United States, 55407
Hennepin County Medical Center
Minneapolis, Minnesota, United States, 55415
Health Partners Inc
Minneapolis, Minnesota, United States, 55454
North Memorial Medical Health Center
Robbinsdale, Minnesota, United States, 55422
Mayo Clinic
Rochester, Minnesota, United States, 55905
Coborn Cancer Center at Saint Cloud Hospital
Saint Cloud, Minnesota, United States, 56303
Regions Hospital
Saint Paul, Minnesota, United States, 55101
United Hospital
Saint Paul, Minnesota, United States, 55102
Rice Memorial Hospital
Willmar, Minnesota, United States, 56201
Minnesota Oncology Hematology PA-Woodbury
Woodbury, Minnesota, United States, 55125
United States, Mississippi
University of Mississippi Medical Center
Jackson, Mississippi, United States, 39216
United States, Missouri
Southeast Cancer Center
Cape Girardeau, Missouri, United States, 63703
Saint Luke's Hospital
Chesterfield, Missouri, United States, 63017
Centerpoint Medical Center LLC
Independence, Missouri, United States, 64057
Saint Luke's Hospital of Kansas City
Kansas City, Missouri, United States, 64111
Saint Luke's East - Lee's Summit
Lee's Summit, Missouri, United States, 64086
Washington University School of Medicine
Saint Louis, Missouri, United States, 63110
Missouri Baptist Medical Center
Saint Louis, Missouri, United States, 63131
Mercy Hospital Saint Louis
Saint Louis, Missouri, United States, 63141
Mercy Hospital Springfield
Springfield, Missouri, United States, 65804
CoxHealth South Hospital
Springfield, Missouri, United States, 65807
United States, Montana
Billings Clinic Cancer Center
Billings, Montana, United States, 59101
Bozeman Deaconess Hospital
Bozeman, Montana, United States, 59715
Benefis Healthcare- Sletten Cancer Institute
Great Falls, Montana, United States, 59405
United States, Nebraska
CHI Health Saint Francis
Grand Island, Nebraska, United States, 68803
CHI Health Good Samaritan
Kearney, Nebraska, United States, 68847
Faith Regional Health Services Carson Cancer Center
Norfolk, Nebraska, United States, 68701
Nebraska Methodist Hospital
Omaha, Nebraska, United States, 68114
Alegent Health Immanuel Medical Center
Omaha, Nebraska, United States, 68122
Alegent Health Bergan Mercy Medical Center
Omaha, Nebraska, United States, 68124
Nebraska Cancer Specialists - Omaha
Omaha, Nebraska, United States, 68124
Creighton University Medical Center
Omaha, Nebraska, United States, 68131
University of Nebraska Medical Center
Omaha, Nebraska, United States, 68198
United States, Nevada
Renown Regional Medical Center
Reno, Nevada, United States, 89502
United States, New Hampshire
New Hampshire Oncology Hematology PA-Concord
Concord, New Hampshire, United States, 03301
New Hampshire Oncology Hematology PA-Hooksett
Hooksett, New Hampshire, United States, 03106
Dartmouth Hitchcock Medical Center
Lebanon, New Hampshire, United States, 03756
Portsmouth Regional Hospital
Portsmouth, New Hampshire, United States, 03802
United States, New Jersey
John F Kennedy Medical Center
Edison, New Jersey, United States, 08818
Hackensack University Medical Center
Hackensack, New Jersey, United States, 07601
Saint Barnabas Medical Center
Livingston, New Jersey, United States, 07039
Rutgers Cancer Institute of New Jersey-Robert Wood Johnson University Hospital
New Brunswick, New Jersey, United States, 08903
Rutgers Cancer Institute of New Jersey
New Brunswick, New Jersey, United States, 08903
The Valley Hospital-Luckow Pavilion
Paramus, New Jersey, United States, 07652
Valley Hospital
Ridgewood, New Jersey, United States, 07450
Overlook Hospital
Summit, New Jersey, United States, 07902
Valley Health System-Hematology/Oncology
Westwood, New Jersey, United States, 07675
United States, New York
Montefiore Medical Center - Moses Campus
Bronx, New York, United States, 10467
Roswell Park Cancer Institute
Buffalo, New York, United States, 14263
Mary Imogene Bassett Hospital
Cooperstown, New York, United States, 13326
Mount Sinai Hospital
New York, New York, United States, 10029
University of Rochester
Rochester, New York, United States, 14642
State University of New York Upstate Medical University
Syracuse, New York, United States, 13210
United States, North Carolina
Mission Hospital Inc-Memorial Campus
Asheville, North Carolina, United States, 28801
UNC Lineberger Comprehensive Cancer Center
Chapel Hill, North Carolina, United States, 27599
East Carolina University
Greenville, North Carolina, United States, 27858
Vidant Oncology-Kinston
Kinston, North Carolina, United States, 28501
Wake Forest University Health Sciences
Winston-Salem, North Carolina, United States, 27157
United States, North Dakota
Roger Maris Cancer Center
Fargo, North Dakota, United States, 58122
Sanford Broadway Medical Center
Fargo, North Dakota, United States, 58122
Sanford Clinic North-Fargo
Fargo, North Dakota, United States, 58122
Altru Cancer Center
Grand Forks, North Dakota, United States, 58201
United States, Ohio
Cleveland Clinic Akron General
Akron, Ohio, United States, 44307
Mercy Medical Center
Canton, Ohio, United States, 44708
Adena Regional Medical Center
Chillicothe, Ohio, United States, 45601
University of Cincinnati/Barrett Cancer Center
Cincinnati, Ohio, United States, 45219
Cleveland Clinic Foundation
Cleveland, Ohio, United States, 44195
Ohio State University Comprehensive Cancer Center
Columbus, Ohio, United States, 43210
Mount Carmel East Hospital
Columbus, Ohio, United States, 43213
Riverside Methodist Hospital
Columbus, Ohio, United States, 43214
Grant Medical Center
Columbus, Ohio, United States, 43215
Good Samaritan Hospital - Dayton
Dayton, Ohio, United States, 45406
Miami Valley Hospital
Dayton, Ohio, United States, 45409
Dayton Physicians LLC-Samaritan North
Dayton, Ohio, United States, 45415
Samaritan North Health Center
Dayton, Ohio, United States, 45415
Armes Family Cancer Center
Findlay, Ohio, United States, 45840
Blanchard Valley Hospital
Findlay, Ohio, United States, 45840
Orion Cancer Care
Findlay, Ohio, United States, 45840
Wayne Hospital
Greenville, Ohio, United States, 45331
Toledo Clinic Cancer Centers-Maumee
Maumee, Ohio, United States, 43537
Saint Charles Hospital
Oregon, Ohio, United States, 43616
Mercy Health Perrysburg Cancer Center
Perrysburg, Ohio, United States, 43551
Flower Hospital
Sylvania, Ohio, United States, 43560
Mercy Saint Anne Hospital
Toledo, Ohio, United States, 43623
Toledo Clinic Cancer Centers-Toledo
Toledo, Ohio, United States, 43623
University Pointe
West Chester, Ohio, United States, 45069
United States, Oklahoma
University of Oklahoma Health Sciences Center
Oklahoma City, Oklahoma, United States, 73104
Oklahoma Cancer Specialists and Research Institute-Tulsa
Tulsa, Oklahoma, United States, 74146
United States, Oregon
Legacy Good Samaritan Hospital and Medical Center
Portland, Oregon, United States, 97210
Providence Portland Medical Center
Portland, Oregon, United States, 97213
Providence Saint Vincent Medical Center
Portland, Oregon, United States, 97225
Kaiser Permanente Northwest
Portland, Oregon, United States, 97227
United States, Pennsylvania
Abington Memorial Hospital
Abington, Pennsylvania, United States, 19001
Lehigh Valley Hospital-Cedar Crest
Allentown, Pennsylvania, United States, 18103
Bryn Mawr Hospital
Bryn Mawr, Pennsylvania, United States, 19010
Geisinger Medical Center
Danville, Pennsylvania, United States, 17822
UPMC Pinnacle Cancer Center/Community Osteopathic Campus
Harrisburg, Pennsylvania, United States, 17109
Lancaster General Hospital
Lancaster, Pennsylvania, United States, 17604
Paoli Memorial Hospital
Paoli, Pennsylvania, United States, 19301
Allegheny General Hospital
Pittsburgh, Pennsylvania, United States, 15212
University of Pittsburgh Cancer Institute (UPCI)
Pittsburgh, Pennsylvania, United States, 15232
Guthrie Medical Group PC-Robert Packer Hospital
Sayre, Pennsylvania, United States, 18840
Geisinger Wyoming Valley/Henry Cancer Center
Wilkes-Barre, Pennsylvania, United States, 18711
UPMC Susquehanna
Williamsport, Pennsylvania, United States, 17701
Lankenau Medical Center
Wynnewood, Pennsylvania, United States, 19096
United States, Rhode Island
Rhode Island Hospital
Providence, Rhode Island, United States, 02903
United States, South Carolina
Roper Hospital
Charleston, South Carolina, United States, 29401
Charleston Hematology Oncology Associates-Roper
Charleston, South Carolina, United States, 29403
Lowcountry Hematology Oncology PA-North Charleston
Charleston, South Carolina, United States, 29406
Bon Secours Saint Francis Hospital
Charleston, South Carolina, United States, 29414
Charleston Hematology Oncology Associates PA-Saint Francis
Charleston, South Carolina, United States, 29414
Lowcountry Hematology Oncology PA-West Ashley
Charleston, South Carolina, United States, 29414
Medical University of South Carolina
Charleston, South Carolina, United States, 29425
Greenville Health System Cancer Institute-Easley
Easley, South Carolina, United States, 29640
Gibbs Cancer Center-Gaffney
Gaffney, South Carolina, United States, 29341
Greenville Health System Cancer Institute-Andrews
Greenville, South Carolina, United States, 29601
Saint Francis Hospital
Greenville, South Carolina, United States, 29601
Greenville Health System Cancer Institute-Butternut
Greenville, South Carolina, United States, 29605
Greenville Health System Cancer Institute-Faris
Greenville, South Carolina, United States, 29605
Greenville Memorial Hospital
Greenville, South Carolina, United States, 29605
Saint Francis Cancer Center
Greenville, South Carolina, United States, 29607
Greenville Health System Cancer Institute-Eastside
Greenville, South Carolina, United States, 29615
Greenville Health System Cancer Institute-Greer
Greer, South Carolina, United States, 29650
Gibbs Cancer Center-Pelham
Greer, South Carolina, United States, 29651
Lowcountry Hematology Oncology PA-Mount Pleasant
Mount Pleasant, South Carolina, United States, 29464
Greenville Health System Cancer Institute-Seneca
Seneca, South Carolina, United States, 29672
Spartanburg Medical Center
Spartanburg, South Carolina, United States, 29303
Greenville Health System Cancer Institute-Spartanburg
Spartanburg, South Carolina, United States, 29307
United States, South Dakota
Avera Cancer Institute-Aberdeen
Aberdeen, South Dakota, United States, 57401
Rapid City Regional Hospital
Rapid City, South Dakota, United States, 57701
Sanford Cancer Center Oncology Clinic
Sioux Falls, South Dakota, United States, 57104
Avera Cancer Institute
Sioux Falls, South Dakota, United States, 57105
Sanford USD Medical Center - Sioux Falls
Sioux Falls, South Dakota, United States, 57117-5134
United States, Tennessee
Wellmont Holston Valley Hospital and Medical Center
Kingsport, Tennessee, United States, 37660
University of Tennessee - Knoxville
Knoxville, Tennessee, United States, 37920
Vanderbilt University/Ingram Cancer Center
Nashville, Tennessee, United States, 37232
United States, Texas
UT Southwestern/Simmons Cancer Center-Dallas
Dallas, Texas, United States, 75390
Brooke Army Medical Center
Fort Sam Houston, Texas, United States, 78234
Baylor College of Medicine/Dan L Duncan Comprehensive Cancer Center
Houston, Texas, United States, 77030
Ben Taub General Hospital
Houston, Texas, United States, 77030
M D Anderson Cancer Center
Houston, Texas, United States, 77030
Memorial Hermann Texas Medical Center
Houston, Texas, United States, 77030
United States, Utah
Huntsman Cancer Institute/University of Utah
Salt Lake City, Utah, United States, 84112
United States, Vermont
University of Vermont College of Medicine
Burlington, Vermont, United States, 05405
United States, Virginia
University of Virginia Cancer Center
Charlottesville, Virginia, United States, 22908
Danville Hematology Oncology
Danville, Virginia, United States, 24541
Inova Fairfax Hospital
Falls Church, Virginia, United States, 22042
United States, Washington
MultiCare Auburn Medical Center
Auburn, Washington, United States, 98001
PeaceHealth Saint Joseph Medical Center
Bellingham, Washington, United States, 98225
Highline Medical Center-Main Campus
Burien, Washington, United States, 98166
MultiCare Gig Harbor Medical Park
Gig Harbor, Washington, United States, 98335
Jefferson Healthcare
Port Townsend, Washington, United States, 98368
MultiCare Good Samaritan Hospital
Puyallup, Washington, United States, 98372
Virginia Mason Medical Center
Seattle, Washington, United States, 98101
Franciscan Research Center-Northwest Medical Plaza
Tacoma, Washington, United States, 98405
MultiCare Tacoma General Hospital
Tacoma, Washington, United States, 98405
Northwest Medical Specialties PLLC
Tacoma, Washington, United States, 98405
PeaceHealth Southwest Medical Center
Vancouver, Washington, United States, 98664
United States, West Virginia
Edwards Comprehensive Cancer Center
Huntington, West Virginia, United States, 25701
West Virginia University Healthcare
Morgantown, West Virginia, United States, 26506
United States, Wisconsin
Aurora Cancer Care-Southern Lakes VLCC
Burlington, Wisconsin, United States, 53105
HSHS Sacred Heart Hospital
Eau Claire, Wisconsin, United States, 54701
Marshfield Clinic Cancer Center at Sacred Heart
Eau Claire, Wisconsin, United States, 54701
Aurora Health Center-Fond du Lac
Fond Du Lac, Wisconsin, United States, 54937
Aurora Health Care Germantown Health Center
Germantown, Wisconsin, United States, 53022
Aurora Cancer Care-Grafton
Grafton, Wisconsin, United States, 53024
Green Bay Oncology at Saint Vincent Hospital
Green Bay, Wisconsin, United States, 54301-3526
Saint Vincent Hospital Cancer Center Green Bay
Green Bay, Wisconsin, United States, 54301
Green Bay Oncology Limited at Saint Mary's Hospital
Green Bay, Wisconsin, United States, 54303
Saint Vincent Hospital Cancer Center at Saint Mary's
Green Bay, Wisconsin, United States, 54303
Aurora BayCare Medical Center
Green Bay, Wisconsin, United States, 54311
Mercy Health System
Janesville, Wisconsin, United States, 53547
Gundersen Lutheran Medical Center
La Crosse, Wisconsin, United States, 54601
University of Wisconsin Hospital and Clinics
Madison, Wisconsin, United States, 53792
Aurora Bay Area Medical Group-Marinette
Marinette, Wisconsin, United States, 54143
Vince Lombardi Cancer Clinic-Marinette
Marinette, Wisconsin, United States, 54143
Marshfield Clinic
Marshfield, Wisconsin, United States, 54449
Marshfield Medical Center
Marshfield, Wisconsin, United States, 54449
Aurora Cancer Care-Milwaukee
Milwaukee, Wisconsin, United States, 53209
Aurora Saint Luke's Medical Center
Milwaukee, Wisconsin, United States, 53215
Froedtert and the Medical College of Wisconsin
Milwaukee, Wisconsin, United States, 53226
Aurora Sinai Medical Center
Milwaukee, Wisconsin, United States, 53233
Marshfield Clinic-Minocqua Center
Minocqua, Wisconsin, United States, 54548
ProHealth D N Greenwald Center
Mukwonago, Wisconsin, United States, 53149
ProHealth Oconomowoc Memorial Hospital
Oconomowoc, Wisconsin, United States, 53066
Green Bay Oncology - Oconto Falls
Oconto Falls, Wisconsin, United States, 54154
Vince Lombardi Cancer Clinic - Oshkosh
Oshkosh, Wisconsin, United States, 54904
Aurora Cancer Care-Racine
Racine, Wisconsin, United States, 53406
Lakeview Medical Center-Marshfield Clinic
Rice Lake, Wisconsin, United States, 54868
Marshfield Clinic-Rice Lake Center
Rice Lake, Wisconsin, United States, 54868
Vince Lombardi Cancer Clinic-Sheboygan
Sheboygan, Wisconsin, United States, 53081
Saint Vincent Hospital Cancer Center at Sturgeon Bay
Sturgeon Bay, Wisconsin, United States, 54235-1495
Green Bay Oncology - Sturgeon Bay
Sturgeon Bay, Wisconsin, United States, 54235
Aurora Medical Center in Summit
Summit, Wisconsin, United States, 53066
Vince Lombardi Cancer Clinic-Two Rivers
Two Rivers, Wisconsin, United States, 54241
Aurora Cancer Care-Waukesha
Waukesha, Wisconsin, United States, 53188
ProHealth Waukesha Memorial Hospital
Waukesha, Wisconsin, United States, 53188
UW Cancer Center at ProHealth Care
Waukesha, Wisconsin, United States, 53188
Aurora Cancer Care-Milwaukee West
Wauwatosa, Wisconsin, United States, 53226
Aurora West Allis Medical Center
West Allis, Wisconsin, United States, 53227
Diagnostic and Treatment Center
Weston, Wisconsin, United States, 54476
Marshfield Clinic - Weston Center
Weston, Wisconsin, United States, 54476
Puerto Rico
Fundacion De Investigacion de Diego
San Juan, Puerto Rico, 00927
Sponsors and Collaborators
National Cancer Institute (NCI)
Investigators
Principal Investigator: Jann Sarkaria Alliance for Clinical Trials in Oncology

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: National Cancer Institute (NCI)
ClinicalTrials.gov Identifier: NCT02152982     History of Changes
Other Study ID Numbers: NCI-2014-00616
NCI-2014-00616 ( Registry Identifier: CTRP (Clinical Trial Reporting Program) )
A071102
CALGB-A071102
A071102 ( Other Identifier: Alliance for Clinical Trials in Oncology )
A071102 ( Other Identifier: CTEP )
P50CA108961 ( U.S. NIH Grant/Contract )
U10CA180821 ( U.S. NIH Grant/Contract )
U10CA031946 ( U.S. NIH Grant/Contract )
First Posted: June 2, 2014    Key Record Dates
Last Update Posted: August 2, 2018
Last Verified: July 2018

Additional relevant MeSH terms:
Glioblastoma
Gliosarcoma
Astrocytoma
Glioma
Neoplasms, Neuroepithelial
Neuroectodermal Tumors
Neoplasms, Germ Cell and Embryonal
Neoplasms by Histologic Type
Neoplasms
Neoplasms, Glandular and Epithelial
Neoplasms, Nerve Tissue
Temozolomide
Dacarbazine
Veliparib
Antineoplastic Agents, Alkylating
Alkylating Agents
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Poly(ADP-ribose) Polymerase Inhibitors
Enzyme Inhibitors