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This phase II trial studies how well veliparib, radiation therapy, and temozolomide work in treating patients with newly diagnosed malignant glioma without H3 K27M or BRAFV600 mutations. Poly adenosine diphosphate (ADP) ribose polymerases (PARPs) are proteins that help repair DNA mutations. PARP inhibitors, such as veliparib, can keep PARP from working, so tumor cells can't repair themselves, and they may stop growing. Radiation therapy uses high energy x-rays to kill tumor cells and shrink tumors. 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. Giving veliparib, radiation therapy, and temozolomide may work better in treating patients with newly diagnosed malignant glioma without H3 K27M or BRAFV600 mutations compared to radiation therapy and temozolomide alone.
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Accepts Healthy Volunteers
Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms |
No |
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Study Type
An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes. An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes. Searching Both is inclusive of interventional and observational studies. |
Interventional |
| Eligible Ages | 3 Years - 25 Years |
| Gender | All |
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Trial ID:
This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries. |
NCT03581292 |
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Phase
Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans. Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data. Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs. Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use. |
Phase 2 |
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Lead Sponsor
The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data. |
National Cancer Institute (NCI) |
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Principal Investigator
The person who is responsible for the scientific and technical direction of the entire clinical study. |
Matthias A Karajannis |
| Principal Investigator Affiliation | Children's Oncology Group |
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Agency Class
Category of organization(s) involved as sponsor (and collaborator) supporting the trial. |
NIH |
| Overall Status | Active, not recruiting |
| Countries | Australia, Canada, New Zealand, Puerto Rico, United States |
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Conditions
The disease, disorder, syndrome, illness, or injury that is being studied. |
Anaplastic Astrocytoma, Glioblastoma, Malignant Glioma |
PRIMARY OBJECTIVES:
Experimental: Treatment (radiation therapy, veliparib, temozolomide)
CHEMORADIOTHERAPY PHASE: Patients receive veliparib PO BID and undergo 30 daily fractions of radiation therapy 5 days per week for 6-7 weeks in the absence of disease progression or unacceptable toxicity. MAINTENANCE CHEMOTHERAPY: Beginning 4 weeks after chemoradiotherapy phase, patients receive veliparib PO BID and temozolomide PO QD on days 1-5. Treatment repeats every 28 days for up to 10 cycles in the absence of disease progression or unacceptable toxicity.
Radiation: - Radiation Therapy
Undergo radiation therapy
Drug: - Temozolomide
Given PO
Drug: - Veliparib
Given PO
If you are interested in learning more about this trial, find the trial site nearest to your location and contact the site coordinator via email or phone. We also strongly recommend that you consult with your healthcare provider about the trials that may interest you and refer to our terms of service below.
Status
Address
Children's Hospital of Alabama
Birmingham, Alabama, 35233
Status
Address
USA Health Strada Patient Care Center
Mobile, Alabama, 36604
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Address
Banner Children's at Desert
Mesa, Arizona, 85202
Status
Address
Phoenix Childrens Hospital
Phoenix, Arizona, 85016
Status
Address
Arkansas Children's Hospital
Little Rock, Arkansas, 72202-3591
Status
Address
Kaiser Permanente Downey Medical Center
Downey, California, 90242
Status
Address
Loma Linda University Medical Center
Loma Linda, California, 92354
Status
Address
Miller Children's and Women's Hospital Long Beach
Long Beach, California, 90806
Status
Address
Children's Hospital Los Angeles
Los Angeles, California, 90027
Status
Address
Cedars Sinai Medical Center
Los Angeles, California, 90048
Status
Address
Mattel Children's Hospital UCLA
Los Angeles, California, 90095
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Address
Valley Children's Hospital
Madera, California, 93636
Status
Address
UCSF Benioff Children's Hospital Oakland
Oakland, California, 94609
Status
Address
Kaiser Permanente-Oakland
Oakland, California, 94611
Status
Address
Children's Hospital of Orange County
Orange, California, 92868
Status
Address
Lucile Packard Children's Hospital Stanford University
Palo Alto, California, 94304
Status
Address
Lundquist Institute for Biomedical Innovation at Harbor-UCLA Medical Center
Torrance, California, 90502
Status
Address
Children's Hospital Colorado
Aurora, Colorado, 80045
Status
Address
Connecticut Children's Medical Center
Hartford, Connecticut, 06106
Status
Address
Yale University
New Haven, Connecticut, 06520
Status
Address
Alfred I duPont Hospital for Children
Wilmington, Delaware, 19803
Status
Address
MedStar Georgetown University Hospital
Washington, District of Columbia, 20007
Status
Address
Children's National Medical Center
Washington, District of Columbia, 20010
Status
Address
Golisano Children's Hospital of Southwest Florida
Fort Myers, Florida, 33908
Status
Address
Memorial Regional Hospital/Joe DiMaggio Children's Hospital
Hollywood, Florida, 33021
Status
Address
Nemours Children's Clinic-Jacksonville
Jacksonville, Florida, 32207
Status
Address
University of Miami Miller School of Medicine-Sylvester Cancer Center
Miami, Florida, 33136
Status
Address
Nicklaus Children's Hospital
Miami, Florida, 33155
Status
Address
AdventHealth Orlando
Orlando, Florida, 32803
Status
Address
Arnold Palmer Hospital for Children
Orlando, Florida, 32806
Status
Address
Nemours Children's Hospital
Orlando, Florida, 32827
Status
Address
Johns Hopkins All Children's Hospital
Saint Petersburg, Florida, 33701
Status
Address
Tampa General Hospital
Tampa, Florida, 33606
Status
Address
Saint Joseph's Hospital/Children's Hospital-Tampa
Tampa, Florida, 33607
Status
Address
Saint Mary's Hospital
West Palm Beach, Florida, 33407
Status
Address
Children's Healthcare of Atlanta - Egleston
Atlanta, Georgia, 30322
Status
Address
Memorial Health University Medical Center
Savannah, Georgia, 31404
Status
Address
Kapiolani Medical Center for Women and Children
Honolulu, Hawaii, 96826
Status
Address
Saint Luke's Cancer Institute - Boise
Boise, Idaho, 83712
Status
Address
Lurie Children's Hospital-Chicago
Chicago, Illinois, 60611
Status
Address
University of Illinois
Chicago, Illinois, 60612
Status
Address
University of Chicago Comprehensive Cancer Center
Chicago, Illinois, 60637
Status
Address
Loyola University Medical Center
Maywood, Illinois, 60153
Status
Address
Saint Jude Midwest Affiliate
Peoria, Illinois, 61637
Status
Address
Riley Hospital for Children
Indianapolis, Indiana, 46202
Status
Address
Ascension Saint Vincent Indianapolis Hospital
Indianapolis, Indiana, 46260
Status
Address
Blank Children's Hospital
Des Moines, Iowa, 50309
Status
Address
University of Iowa/Holden Comprehensive Cancer Center
Iowa City, Iowa, 52242
Status
Address
University of Kentucky/Markey Cancer Center
Lexington, Kentucky, 40536
Status
Address
Norton Children's Hospital
Louisville, Kentucky, 40202
Status
Address
Children's Hospital New Orleans
New Orleans, Louisiana, 70118
Status
Address
Ochsner Medical Center Jefferson
New Orleans, Louisiana, 70121
Status
Address
Eastern Maine Medical Center
Bangor, Maine, 04401
Status
Address
Johns Hopkins University/Sidney Kimmel Cancer Center
Baltimore, Maryland, 21287
Status
Address
Walter Reed National Military Medical Center
Bethesda, Maryland, 20889-5600
Status
Address
Massachusetts General Hospital Cancer Center
Boston, Massachusetts, 02114
Status
Address
Dana-Farber Cancer Institute
Boston, Massachusetts, 02215
Status
Address
UMass Memorial Medical Center - University Campus
Worcester, Massachusetts, 01655
Status
Address
C S Mott Children's Hospital
Ann Arbor, Michigan, 48109
Status
Address
Wayne State University/Karmanos Cancer Institute
Detroit, Michigan, 48201
Status
Address
Ascension Saint John Hospital
Detroit, Michigan, 48236
Status
Address
Helen DeVos Children's Hospital at Spectrum Health
Grand Rapids, Michigan, 49503
Status
Address
Bronson Methodist Hospital
Kalamazoo, Michigan, 49007
Status
Address
Beaumont Children's Hospital-Royal Oak
Royal Oak, Michigan, 48073
Status
Address
Children's Hospitals and Clinics of Minnesota - Minneapolis
Minneapolis, Minnesota, 55404
Status
Address
University of Minnesota/Masonic Cancer Center
Minneapolis, Minnesota, 55455
Status
Address
Mayo Clinic in Rochester
Rochester, Minnesota, 55905
Status
Address
University of Mississippi Medical Center
Jackson, Mississippi, 39216
Status
Address
Children's Mercy Hospitals and Clinics
Kansas City, Missouri, 64108
Status
Address
Cardinal Glennon Children's Medical Center
Saint Louis, Missouri, 63104
Status
Address
Washington University School of Medicine
Saint Louis, Missouri, 63110
Status
Address
Mercy Hospital Saint Louis
Saint Louis, Missouri, 63141
Status
Address
Children's Hospital and Medical Center of Omaha
Omaha, Nebraska, 68114
Status
Address
University of Nebraska Medical Center
Omaha, Nebraska, 68198
Status
Address
University Medical Center of Southern Nevada
Las Vegas, Nevada, 89102
Status
Address
Sunrise Hospital and Medical Center
Las Vegas, Nevada, 89109
Status
Address
Alliance for Childhood Diseases/Cure 4 the Kids Foundation
Las Vegas, Nevada, 89135
Status
Address
Summerlin Hospital Medical Center
Las Vegas, Nevada, 89144
Status
Address
Renown Regional Medical Center
Reno, Nevada, 89502
Status
Address
Dartmouth Hitchcock Medical Center/Dartmouth Cancer Center
Lebanon, New Hampshire, 03756
Status
Address
Morristown Medical Center
Morristown, New Jersey, 07960
Status
Address
Saint Peter's University Hospital
New Brunswick, New Jersey, 08901
Status
Address
Albany Medical Center
Albany, New York, 12208
Status
Address
Montefiore Medical Center - Moses Campus
Bronx, New York, 10467
Status
Address
Roswell Park Cancer Institute
Buffalo, New York, 14263
Status
Address
Laura and Isaac Perlmutter Cancer Center at NYU Langone
New York, New York, 10016
Status
Address
NYP/Columbia University Medical Center/Herbert Irving Comprehensive Cancer Center
New York, New York, 10032
Status
Address
Memorial Sloan Kettering Cancer Center
New York, New York, 10065
Status
Address
University of Rochester
Rochester, New York, 14642
Status
Address
State University of New York Upstate Medical University
Syracuse, New York, 13210
Status
Address
New York Medical College
Valhalla, New York, 10595
Status
Address
Mission Hospital
Asheville, North Carolina, 28801
Status
Address
UNC Lineberger Comprehensive Cancer Center
Chapel Hill, North Carolina, 27599
Status
Address
Carolinas Medical Center/Levine Cancer Institute
Charlotte, North Carolina, 28203
Status
Address
Duke University Medical Center
Durham, North Carolina, 27710
Status
Address
East Carolina University
Greenville, North Carolina, 27834
Status
Address
Wake Forest University Health Sciences
Winston-Salem, North Carolina, 27157
Status
Address
Sanford Broadway Medical Center
Fargo, North Dakota, 58122
Status
Address
Children's Hospital Medical Center of Akron
Akron, Ohio, 44308
Status
Address
Cincinnati Children's Hospital Medical Center
Cincinnati, Ohio, 45229
Status
Address
Rainbow Babies and Childrens Hospital
Cleveland, Ohio, 44106
Status
Address
Cleveland Clinic Foundation
Cleveland, Ohio, 44195
Status
Address
Nationwide Children's Hospital
Columbus, Ohio, 43205
Status
Address
Dayton Children's Hospital
Dayton, Ohio, 45404
Status
Address
ProMedica Toledo Hospital/Russell J Ebeid Children's Hospital
Toledo, Ohio, 43606
Status
Address
University of Oklahoma Health Sciences Center
Oklahoma City, Oklahoma, 73104
Status
Address
Legacy Emanuel Children's Hospital
Portland, Oregon, 97227
Status
Address
Oregon Health and Science University
Portland, Oregon, 97239
Status
Address
Lehigh Valley Hospital-Cedar Crest
Allentown, Pennsylvania, 18103
Status
Address
Geisinger Medical Center
Danville, Pennsylvania, 17822
Status
Address
Children's Hospital of Philadelphia
Philadelphia, Pennsylvania, 19104
Status
Address
Children's Hospital of Pittsburgh of UPMC
Pittsburgh, Pennsylvania, 15224
Status
Address
Rhode Island Hospital
Providence, Rhode Island, 02903
Status
Address
Medical University of South Carolina
Charleston, South Carolina, 29425
Status
Address
Prisma Health Richland Hospital
Columbia, South Carolina, 29203
Status
Address
BI-LO Charities Children's Cancer Center
Greenville, South Carolina, 29605
Status
Address
Sanford USD Medical Center - Sioux Falls
Sioux Falls, South Dakota, 57117-5134
Status
Address
T C Thompson Children's Hospital
Chattanooga, Tennessee, 37403
Status
Address
East Tennessee Childrens Hospital
Knoxville, Tennessee, 37916
Status
Address
Saint Jude Children's Research Hospital
Memphis, Tennessee, 38105
Status
Address
The Children's Hospital at TriStar Centennial
Nashville, Tennessee, 37203
Status
Address
Vanderbilt University/Ingram Cancer Center
Nashville, Tennessee, 37232
Status
Address
Dell Children's Medical Center of Central Texas
Austin, Texas, 78723
Status
Address
Driscoll Children's Hospital
Corpus Christi, Texas, 78411
Status
Address
Medical City Dallas Hospital
Dallas, Texas, 75230
Status
Address
UT Southwestern/Simmons Cancer Center-Dallas
Dallas, Texas, 75390
Status
Address
Cook Children's Medical Center
Fort Worth, Texas, 76104
Status
Address
Baylor College of Medicine/Dan L Duncan Comprehensive Cancer Center
Houston, Texas, 77030
Status
Address
M D Anderson Cancer Center
Houston, Texas, 77030
Status
Address
Children's Hospital of San Antonio
San Antonio, Texas, 78207
Status
Address
Methodist Children's Hospital of South Texas
San Antonio, Texas, 78229
Status
Address
University of Texas Health Science Center at San Antonio
San Antonio, Texas, 78229
Status
Address
Scott and White Memorial Hospital
Temple, Texas, 76508
Status
Address
Primary Children's Hospital
Salt Lake City, Utah, 84113
Status
Address
Children's Hospital of The King's Daughters
Norfolk, Virginia, 23507
Status
Address
Naval Medical Center - Portsmouth
Portsmouth, Virginia, 23708-2197
Status
Address
Virginia Commonwealth University/Massey Cancer Center
Richmond, Virginia, 23298
Status
Address
Seattle Children's Hospital
Seattle, Washington, 98105
Status
Address
Providence Sacred Heart Medical Center and Children's Hospital
Spokane, Washington, 99204
Status
Address
Mary Bridge Children's Hospital and Health Center
Tacoma, Washington, 98405
Status
Address
Madigan Army Medical Center
Tacoma, Washington, 98431
Status
Address
West Virginia University Healthcare
Morgantown, West Virginia, 26506
Status
Address
University of Wisconsin Carbone Cancer Center
Madison, Wisconsin, 53792
Status
Address
Marshfield Medical Center-Marshfield
Marshfield, Wisconsin, 54449
Status
Address
Children's Hospital of Wisconsin
Milwaukee, Wisconsin, 53226
Status
Address
John Hunter Children's Hospital
Hunter Regional Mail Centre, New South Wales, 2310
Status
Address
Sydney Children's Hospital
Randwick, New South Wales, 2031
Status
Address
The Children's Hospital at Westmead
Westmead, New South Wales, 2145
Status
Address
Queensland Children's Hospital
South Brisbane, Queensland, 4101
Status
Address
Monash Medical Center-Clayton Campus
Clayton, Victoria, 3168
Status
Address
Royal Children's Hospital
Parkville, Victoria, 3052
Status
Address
Perth Children's Hospital
Perth, Western Australia, 6009
Status
Address
Alberta Children's Hospital
Calgary, Alberta, T3B 6A8
Status
Address
British Columbia Children's Hospital
Vancouver, British Columbia, V6H 3V4
Status
Address
Janeway Child Health Centre
Saint John's, Newfoundland and Labrador, A1B 3V6
Status
Address
IWK Health Centre
Halifax, Nova Scotia, B3K 6R8
Status
Address
McMaster Children's Hospital at Hamilton Health Sciences
Hamilton, Ontario, L8N 3Z5
Status
Address
The Montreal Children's Hospital of the MUHC
Montreal, Quebec, H3H 1P3
Status
Address
Centre Hospitalier Universitaire Sainte-Justine
Montreal, Quebec, H3T 1C5
Status
Address
CHU de Quebec-Centre Hospitalier de l'Universite Laval (CHUL)
Quebec, , G1V 4G2
Status
Address
Starship Children's Hospital
Grafton, Auckland, 1145
Status
Address
Christchurch Hospital
Christchurch, , 8011
Status
Address
HIMA San Pablo Oncologic Hospital
Caguas, , 00726
