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

NCT ID: NCT02152982

Last Updated: 2025-11-28

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

ACTIVE_NOT_RECRUITING

Clinical Phase

PHASE2/PHASE3

Total Enrollment

447 participants

Study Classification

INTERVENTIONAL

Study Start Date

2014-12-15

Study Completion Date

2025-12-26

Brief Summary

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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.

Detailed Description

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PRIMARY OBJECTIVE:

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.

CORRELATIVE SCIENCE 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 placebo 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 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.

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

Conditions

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Glioblastoma Gliosarcoma

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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Arm I (temozolomide, placebo)

Patients receive temozolomide PO QD on days 1-5 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.

Group Type PLACEBO_COMPARATOR

Laboratory Biomarker Analysis

Intervention Type OTHER

Correlative studies

Placebo Administration

Intervention Type OTHER

Given PO

Quality-of-Life Assessment

Intervention Type OTHER

Ancillary studies

Temozolomide

Intervention Type DRUG

Given PO

Veliparib

Intervention Type DRUG

Given PO

Arm II (temozolomide, veliparib)

Patients receive temozolomide as in Arm I 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.

Group Type EXPERIMENTAL

Laboratory Biomarker Analysis

Intervention Type OTHER

Correlative studies

Quality-of-Life Assessment

Intervention Type OTHER

Ancillary studies

Temozolomide

Intervention Type DRUG

Given PO

Veliparib

Intervention Type DRUG

Given PO

Interventions

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Laboratory Biomarker Analysis

Correlative studies

Intervention Type OTHER

Placebo Administration

Given PO

Intervention Type OTHER

Quality-of-Life Assessment

Ancillary studies

Intervention Type OTHER

Temozolomide

Given PO

Intervention Type DRUG

Veliparib

Given PO

Intervention Type DRUG

Other Intervention Names

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Quality of Life Assessment CCRG-81045 Gliotem 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 Temizole Temodal Temodar Temomedac TMZ ABT 888 ABT-888 ABT888 PARP-1 inhibitor ABT-888

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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National Cancer Institute (NCI)

NIH

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Jann N Sarkaria

Role: PRINCIPAL_INVESTIGATOR

Alliance for Clinical Trials in Oncology

Locations

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University of Alabama at Birmingham Cancer Center

Birmingham, Alabama, United States

Site Status

Katmai Oncology Group

Anchorage, Alaska, United States

Site Status

Providence Alaska Medical Center

Anchorage, Alaska, United States

Site Status

Mayo Clinic in Arizona

Scottsdale, Arizona, United States

Site Status

Banner University Medical Center - Tucson

Tucson, Arizona, United States

Site Status

University of Arkansas for Medical Sciences

Little Rock, Arkansas, United States

Site Status

Kaiser Permanente-Deer Valley Medical Center

Antioch, California, United States

Site Status

Providence Saint Joseph Medical Center/Disney Family Cancer Center

Burbank, California, United States

Site Status

Mills-Peninsula Medical Center

Burlingame, California, United States

Site Status

John Muir Medical Center-Concord

Concord, California, United States

Site Status

Kaiser Permanente-Fremont

Fremont, California, United States

Site Status

Fresno Cancer Center

Fresno, California, United States

Site Status

Kaiser Permanente-Fresno

Fresno, California, United States

Site Status

Saint Jude Medical Center

Fullerton, California, United States

Site Status

UC San Diego Moores Cancer Center

La Jolla, California, United States

Site Status

Kaiser Permanente Los Angeles Medical Center

Los Angeles, California, United States

Site Status

Los Angeles General Medical Center

Los Angeles, California, United States

Site Status

USC / Norris Comprehensive Cancer Center

Los Angeles, California, United States

Site Status

Kaiser Permanente-Modesto

Modesto, California, United States

Site Status

USC Norris Oncology/Hematology-Newport Beach

Newport Beach, California, United States

Site Status

Kaiser Permanente Oakland-Broadway

Oakland, California, United States

Site Status

Kaiser Permanente-Oakland

Oakland, California, United States

Site Status

Saint Joseph Hospital - Orange

Orange, California, United States

Site Status

Kaiser Permanente-Rancho Cordova Cancer Center

Rancho Cordova, California, United States

Site Status

Kaiser Permanente-Redwood City

Redwood City, California, United States

Site Status

Kaiser Permanente-Richmond

Richmond, California, United States

Site Status

Rohnert Park Cancer Center

Rohnert Park, California, United States

Site Status

Kaiser Permanente-Roseville

Roseville, California, United States

Site Status

Sutter Roseville Medical Center

Roseville, California, United States

Site Status

The Permanente Medical Group-Roseville Radiation Oncology

Roseville, California, United States

Site Status

Sutter Medical Center Sacramento

Sacramento, California, United States

Site Status

University of California Davis Comprehensive Cancer Center

Sacramento, California, United States

Site Status

Kaiser Permanente-South Sacramento

Sacramento, California, United States

Site Status

South Sacramento Cancer Center

Sacramento, California, United States

Site Status

Kaiser Permanente Sacramento Medical Center

Sacramento, California, United States

Site Status

Kaiser Permanente-San Francisco

San Francisco, California, United States

Site Status

UCSF Medical Center-Parnassus

San Francisco, California, United States

Site Status

Kaiser Permanente-Santa Teresa-San Jose

San Jose, California, United States

Site Status

Kaiser Permanente San Leandro

San Leandro, California, United States

Site Status

Kaiser Permanente-San Rafael

San Rafael, California, United States

Site Status

Kaiser Permanente Medical Center - Santa Clara

Santa Clara, California, United States

Site Status

Palo Alto Medical Foundation-Santa Cruz

Santa Cruz, California, United States

Site Status

Kaiser Permanente-Santa Rosa

Santa Rosa, California, United States

Site Status

Kaiser Permanente Cancer Treatment Center

South San Francisco, California, United States

Site Status

Kaiser Permanente-South San Francisco

South San Francisco, California, United States

Site Status

Kaiser Permanente-Stockton

Stockton, California, United States

Site Status

Northbay Cancer Center

Vacaville, California, United States

Site Status

Kaiser Permanente Medical Center-Vacaville

Vacaville, California, United States

Site Status

Kaiser Permanente-Vallejo

Vallejo, California, United States

Site Status

Kaiser Permanente-Walnut Creek

Walnut Creek, California, United States

Site Status

John Muir Medical Center-Walnut Creek

Walnut Creek, California, United States

Site Status

UCHealth University of Colorado Hospital

Aurora, Colorado, United States

Site Status

Boulder Community Foothills Hospital

Boulder, Colorado, United States

Site Status

Rocky Mountain Cancer Centers-Boulder

Boulder, Colorado, United States

Site Status

Penrose-Saint Francis Healthcare

Colorado Springs, Colorado, United States

Site Status

Rocky Mountain Cancer Centers-Penrose

Colorado Springs, Colorado, United States

Site Status

Kaiser Permanente-Franklin

Denver, Colorado, United States

Site Status

Swedish Medical Center

Englewood, Colorado, United States

Site Status

Poudre Valley Hospital

Fort Collins, Colorado, United States

Site Status

Banner North Colorado Medical Center

Greeley, Colorado, United States

Site Status

Kaiser Permanente-Rock Creek

Lafayette, Colorado, United States

Site Status

Rocky Mountain Cancer Centers-Littleton

Littleton, Colorado, United States

Site Status

AdventHealth Littleton

Littleton, Colorado, United States

Site Status

Kaiser Permanente-Lone Tree

Lone Tree, Colorado, United States

Site Status

Rocky Mountain Cancer Centers-Longmont

Longmont, Colorado, United States

Site Status

Banner North Colorado Medical Center - Loveland Campus

Loveland, Colorado, United States

Site Status

Intermountain Health Lutheran Hospital

Wheat Ridge, Colorado, United States

Site Status

Hartford Hospital

Hartford, Connecticut, United States

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Smilow Cancer Hospital Care Center at Saint Francis

Hartford, Connecticut, United States

Site Status

Midstate Medical Center

Meriden, Connecticut, United States

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The Hospital of Central Connecticut

New Britain, Connecticut, United States

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Yale University

New Haven, Connecticut, United States

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Boca Raton Regional Hospital

Boca Raton, Florida, United States

Site Status

UM Sylvester Comprehensive Cancer Center at Deerfield Beach

Deerfield Beach, Florida, United States

Site Status

Memorial Regional Hospital/Joe DiMaggio Children's Hospital

Hollywood, Florida, United States

Site Status

Mayo Clinic in Florida

Jacksonville, Florida, United States

Site Status

Lakeland Regional Health Hollis Cancer Center

Lakeland, Florida, United States

Site Status

University of Miami Miller School of Medicine-Sylvester Cancer Center

Miami, Florida, United States

Site Status

Mount Sinai Medical Center

Miami Beach, Florida, United States

Site Status

AdventHealth Orlando

Orlando, Florida, United States

Site Status

Orlando Health Cancer Institute

Orlando, Florida, United States

Site Status

Memorial Hospital West

Pembroke Pines, Florida, United States

Site Status

Moffitt Cancer Center

Tampa, Florida, United States

Site Status

Piedmont Hospital

Atlanta, Georgia, United States

Site Status

Emory University Hospital/Winship Cancer Institute

Atlanta, Georgia, United States

Site Status

Northside Hospital

Atlanta, Georgia, United States

Site Status

John B Amos Cancer Center

Columbus, Georgia, United States

Site Status

Northeast Georgia Medical Center-Gainesville

Gainesville, Georgia, United States

Site Status

Hawaii Cancer Care Inc - Waterfront Plaza

Honolulu, Hawaii, United States

Site Status

Queen's Cancer Cenrer - POB I

Honolulu, Hawaii, United States

Site Status

Queen's Medical Center

Honolulu, Hawaii, United States

Site Status

Straub Clinic and Hospital

Honolulu, Hawaii, United States

Site Status

Hawaii Cancer Care Inc-Liliha

Honolulu, Hawaii, United States

Site Status

Queen's Cancer Center - Kuakini

Honolulu, Hawaii, United States

Site Status

Saint Alphonsus Cancer Care Center-Boise

Boise, Idaho, United States

Site Status

Kootenai Clinic Cancer Services - Post Falls

Post Falls, Idaho, United States

Site Status

OSF Saint Joseph Medical Center

Bloomington, Illinois, United States

Site Status

Northwestern University

Chicago, Illinois, United States

Site Status

Rush MD Anderson Cancer Center

Chicago, Illinois, United States

Site Status

Cancer Care Specialists of Illinois - Decatur

Decatur, Illinois, United States

Site Status

Decatur Memorial Hospital

Decatur, Illinois, United States

Site Status

Crossroads Cancer Center

Effingham, Illinois, United States

Site Status

NorthShore University HealthSystem-Evanston Hospital

Evanston, Illinois, United States

Site Status

Northwestern Medicine Cancer Center Delnor

Geneva, Illinois, United States

Site Status

NorthShore University HealthSystem-Glenbrook Hospital

Glenview, Illinois, United States

Site Status

NorthShore University HealthSystem-Highland Park Hospital

Highland Park, Illinois, United States

Site Status

Edward Hospital/Cancer Center

Naperville, Illinois, United States

Site Status

Advocate Lutheran General Hospital

Park Ridge, Illinois, United States

Site Status

Illinois CancerCare-Peoria

Peoria, Illinois, United States

Site Status

Methodist Medical Center of Illinois

Peoria, Illinois, United States

Site Status

OSF Saint Francis Medical Center

Peoria, Illinois, United States

Site Status

Edward Hospital/Cancer Center?Plainfield

Plainfield, Illinois, United States

Site Status

Central Illinois Hematology Oncology Center

Springfield, Illinois, United States

Site Status

Southern Illinois University School of Medicine

Springfield, Illinois, United States

Site Status

Springfield Memorial Hospital

Springfield, Illinois, United States

Site Status

Carle Cancer Center

Urbana, Illinois, United States

Site Status

Northwestern Medicine Cancer Center Warrenville

Warrenville, Illinois, United States

Site Status

Parkview Hospital Randallia

Fort Wayne, Indiana, United States

Site Status

Franciscan Health Indianapolis

Indianapolis, Indiana, United States

Site Status

Reid Health

Richmond, Indiana, United States

Site Status

Memorial Hospital of South Bend

South Bend, Indiana, United States

Site Status

Physicians' Clinic of Iowa PC

Cedar Rapids, Iowa, United States

Site Status

Mercy Cancer Center-West Lakes

Clive, Iowa, United States

Site Status

UI Health Care Mission Cancer and Blood - West Des Moines Clinic

Clive, Iowa, United States

Site Status

Iowa Methodist Medical Center

Des Moines, Iowa, United States

Site Status

Mercy Medical Center - Des Moines

Des Moines, Iowa, United States

Site Status

UI Health Care Mission Cancer and Blood - Laurel Clinic

Des Moines, Iowa, United States

Site Status

Mercy Medical Center - North Iowa

Mason City, Iowa, United States

Site Status

Siouxland Regional Cancer Center

Sioux City, Iowa, United States

Site Status

Mercy Medical Center-West Lakes

West Des Moines, Iowa, United States

Site Status

Cancer Center of Kansas - Chanute

Chanute, Kansas, United States

Site Status

Cancer Center of Kansas - Dodge City

Dodge City, Kansas, United States

Site Status

Cancer Center of Kansas - El Dorado

El Dorado, Kansas, United States

Site Status

Cancer Center of Kansas - Fort Scott

Fort Scott, Kansas, United States

Site Status

Cancer Center of Kansas-Independence

Independence, Kansas, United States

Site Status

Cancer Center of Kansas-Kingman

Kingman, Kansas, United States

Site Status

Lawrence Memorial Hospital

Lawrence, Kansas, United States

Site Status

Cancer Center of Kansas-Liberal

Liberal, Kansas, United States

Site Status

Cancer Center of Kansas - McPherson

McPherson, Kansas, United States

Site Status

Cancer Center of Kansas - Newton

Newton, Kansas, United States

Site Status

Menorah Medical Center

Overland Park, Kansas, United States

Site Status

Cancer Center of Kansas - Parsons

Parsons, Kansas, United States

Site Status

Cancer Center of Kansas - Pratt

Pratt, Kansas, United States

Site Status

Cancer Center of Kansas - Salina

Salina, Kansas, United States

Site Status

Cancer Center of Kansas - Wellington

Wellington, Kansas, United States

Site Status

Cancer Center of Kansas-Wichita Medical Arts Tower

Wichita, Kansas, United States

Site Status

Ascension Via Christi Hospitals Wichita

Wichita, Kansas, United States

Site Status

Cancer Center of Kansas - Wichita

Wichita, Kansas, United States

Site Status

Cancer Center of Kansas - Winfield

Winfield, Kansas, United States

Site Status

Baptist Health Corbin

Corbin, Kentucky, United States

Site Status

Baptist Health Lexington

Lexington, Kentucky, United States

Site Status

University of Kentucky/Markey Cancer Center

Lexington, Kentucky, United States

Site Status

Baptist Health Louisville

Louisville, Kentucky, United States

Site Status

Baptist Health Madisonville/Merle Mahr Cancer Center

Madisonville, Kentucky, United States

Site Status

Baptist Health Paducah

Paducah, Kentucky, United States

Site Status

Mary Bird Perkins Cancer Center

Baton Rouge, Louisiana, United States

Site Status

The NeuroMedical Center-Clinic

Baton Rouge, Louisiana, United States

Site Status

Ochsner Medical Center Jefferson

New Orleans, Louisiana, United States

Site Status

Eastern Maine Medical Center

Bangor, Maine, United States

Site Status

Lafayette Family Cancer Center-EMMC

Brewer, Maine, United States

Site Status

New England Cancer Specialists - Topsham

Topsham, Maine, United States

Site Status

New England Cancer Specialists

Westbrook, Maine, United States

Site Status

Luminis Health Anne Arundel Medical Center

Annapolis, Maryland, United States

Site Status

Sinai Hospital of Baltimore

Baltimore, Maryland, United States

Site Status

Northwest Hospital Center

Randallstown, Maryland, United States

Site Status

TidalHealth Peninsula Regional

Salisbury, Maryland, United States

Site Status

Massachusetts General Hospital Cancer Center

Boston, Massachusetts, United States

Site Status

Dana-Farber Cancer Institute

Boston, Massachusetts, United States

Site Status

Simonds-Sinon Regional Cancer Center

Fitchburg, Massachusetts, United States

Site Status

Lowell General Hospital

Lowell, Massachusetts, United States

Site Status

UMass Memorial Medical Center - University Campus

Worcester, Massachusetts, United States

Site Status

Trinity Health Saint Joseph Mercy Hospital Ann Arbor

Ann Arbor, Michigan, United States

Site Status

University of Michigan Comprehensive Cancer Center

Ann Arbor, Michigan, United States

Site Status

Henry Ford Health Saint John Hospital

Detroit, Michigan, United States

Site Status

OSF Saint Francis Hospital and Medical Group

Escanaba, Michigan, United States

Site Status

Genesys Hurley Cancer Institute

Flint, Michigan, United States

Site Status

Corewell Health Grand Rapids Hospitals - Butterworth Hospital

Grand Rapids, Michigan, United States

Site Status

Trinity Health Grand Rapids Hospital

Grand Rapids, Michigan, United States

Site Status

West Michigan Cancer Center

Kalamazoo, Michigan, United States

Site Status

University of Michigan Health - Sparrow Lansing

Lansing, Michigan, United States

Site Status

Trinity Health Saint Mary Mercy Livonia Hospital

Livonia, Michigan, United States

Site Status

Henry Ford Health Providence Novi Hospital

Novi, Michigan, United States

Site Status

Trinity Health Saint Joseph Mercy Oakland Hospital

Pontiac, Michigan, United States

Site Status

Corewell Health Reed City Hospital

Reed City, Michigan, United States

Site Status

Corewell Health William Beaumont University Hospital

Royal Oak, Michigan, United States

Site Status

MyMichigan Medical Center Saginaw

Saginaw, Michigan, United States

Site Status

Corewell Health Lakeland Hospitals - Marie Yeager Cancer Center

Saint Joseph, Michigan, United States

Site Status

Corewell Health Lakeland Hospitals - Saint Joseph Hospital

Saint Joseph, Michigan, United States

Site Status

Henry Ford Health Providence Southfield Hospital

Southfield, Michigan, United States

Site Status

Munson Medical Center

Traverse City, Michigan, United States

Site Status

University of Michigan Health - West

Wyoming, Michigan, United States

Site Status

Sanford Joe Lueken Cancer Center

Bemidji, Minnesota, United States

Site Status

Mercy Hospital

Coon Rapids, Minnesota, United States

Site Status

Essentia Health Cancer Center

Duluth, Minnesota, United States

Site Status

Saint Luke's Hospital of Duluth

Duluth, Minnesota, United States

Site Status

Fairview Southdale Hospital

Edina, Minnesota, United States

Site Status

Abbott-Northwestern Hospital

Minneapolis, Minnesota, United States

Site Status

Hennepin County Medical Center

Minneapolis, Minnesota, United States

Site Status

Health Partners Inc

Minneapolis, Minnesota, United States

Site Status

North Memorial Medical Health Center

Robbinsdale, Minnesota, United States

Site Status

Mayo Clinic in Rochester

Rochester, Minnesota, United States

Site Status

Coborn Cancer Center at Saint Cloud Hospital

Saint Cloud, Minnesota, United States

Site Status

Regions Hospital

Saint Paul, Minnesota, United States

Site Status

United Hospital

Saint Paul, Minnesota, United States

Site Status

Rice Memorial Hospital

Willmar, Minnesota, United States

Site Status

Minnesota Oncology Hematology PA-Woodbury

Woodbury, Minnesota, United States

Site Status

University of Mississippi Medical Center

Jackson, Mississippi, United States

Site Status

Mercy Cancer Center - Cape Girardeau

Cape Girardeau, Missouri, United States

Site Status

Saint Luke's Hospital

Chesterfield, Missouri, United States

Site Status

Centerpoint Medical Center LLC

Independence, Missouri, United States

Site Status

Saint Luke's Hospital of Kansas City

Kansas City, Missouri, United States

Site Status

Saint Luke's East - Lee's Summit

Lee's Summit, Missouri, United States

Site Status

Mercy Hospital Springfield

Springfield, Missouri, United States

Site Status

CoxHealth South Hospital

Springfield, Missouri, United States

Site Status

Washington University School of Medicine

St Louis, Missouri, United States

Site Status

Missouri Baptist Medical Center

St Louis, Missouri, United States

Site Status

Mercy Hospital Saint Louis

St Louis, Missouri, United States

Site Status

Billings Clinic Cancer Center

Billings, Montana, United States

Site Status

Bozeman Health Deaconess Hospital

Bozeman, Montana, United States

Site Status

Benefis Sletten Cancer Institute

Great Falls, Montana, United States

Site Status

Nebraska Cancer Specialists/Oncology Hematology West PC

Grand Island, Nebraska, United States

Site Status

CHI Health Good Samaritan

Kearney, Nebraska, United States

Site Status

Faith Regional Health Services Carson Cancer Center

Norfolk, Nebraska, United States

Site Status

Nebraska Methodist Hospital

Omaha, Nebraska, United States

Site Status

Alegent Health Immanuel Medical Center

Omaha, Nebraska, United States

Site Status

Alegent Health Bergan Mercy Medical Center

Omaha, Nebraska, United States

Site Status

Nebraska Cancer Specialists - Omaha

Omaha, Nebraska, United States

Site Status

Creighton University Medical Center

Omaha, Nebraska, United States

Site Status

University of Nebraska Medical Center

Omaha, Nebraska, United States

Site Status

Renown Regional Medical Center

Reno, Nevada, United States

Site Status

New Hampshire Oncology Hematology PA-Concord

Concord, New Hampshire, United States

Site Status

Dartmouth Hitchcock Medical Center/Dartmouth Cancer Center

Lebanon, New Hampshire, United States

Site Status

Solinsky Center for Cancer Care

Manchester, New Hampshire, United States

Site Status

Portsmouth Regional Hospital

Portsmouth, New Hampshire, United States

Site Status

John F Kennedy Medical Center

Edison, New Jersey, United States

Site Status

Hackensack University Medical Center

Hackensack, New Jersey, United States

Site Status

Saint Barnabas Medical Center

Livingston, New Jersey, United States

Site Status

Rutgers Cancer Institute of New Jersey-Robert Wood Johnson University Hospital

New Brunswick, New Jersey, United States

Site Status

Rutgers Cancer Institute of New Jersey

New Brunswick, New Jersey, United States

Site Status

The Valley Hospital - Luckow Pavilion

Paramus, New Jersey, United States

Site Status

Valley Health System Ridgewood Campus

Ridgewood, New Jersey, United States

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Overlook Hospital

Summit, New Jersey, United States

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Valley Health System-Hematology/Oncology

Westwood, New Jersey, United States

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Roswell Park Cancer Institute

Buffalo, New York, United States

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Mary Imogene Bassett Hospital

Cooperstown, New York, United States

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Mount Sinai Hospital

New York, New York, United States

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University of Rochester

Rochester, New York, United States

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State University of New York Upstate Medical University

Syracuse, New York, United States

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Montefiore Medical Center - Moses Campus

The Bronx, New York, United States

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Mission Hospital

Asheville, North Carolina, United States

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East Carolina University

Greenville, North Carolina, United States

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ECU Health Oncology Kinston

Kinston, North Carolina, United States

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Wake Forest University Health Sciences

Winston-Salem, North Carolina, United States

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Sanford Broadway Medical Center

Fargo, North Dakota, United States

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Sanford Roger Maris Cancer Center

Fargo, North Dakota, United States

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Altru Cancer Center

Grand Forks, North Dakota, United States

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Cleveland Clinic Akron General

Akron, Ohio, United States

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Cleveland Clinic Mercy Hospital

Canton, Ohio, United States

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Adena Regional Medical Center

Chillicothe, Ohio, United States

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University of Cincinnati Cancer Center-UC Medical Center

Cincinnati, Ohio, United States

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Cleveland Clinic Foundation

Cleveland, Ohio, United States

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Ohio State University Comprehensive Cancer Center

Columbus, Ohio, United States

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Mount Carmel East Hospital

Columbus, Ohio, United States

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Riverside Methodist Hospital

Columbus, Ohio, United States

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Grant Medical Center

Columbus, Ohio, United States

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Good Samaritan Hospital - Dayton

Dayton, Ohio, United States

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Miami Valley Hospital

Dayton, Ohio, United States

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Dayton Physician LLC - Englewood

Dayton, Ohio, United States

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Miami Valley Hospital North

Dayton, Ohio, United States

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Armes Family Cancer Center

Findlay, Ohio, United States

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Blanchard Valley Hospital

Findlay, Ohio, United States

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Orion Cancer Care

Findlay, Ohio, United States

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Wayne Hospital

Greenville, Ohio, United States

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Toledo Clinic Cancer Centers-Maumee

Maumee, Ohio, United States

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Saint Charles Hospital

Oregon, Ohio, United States

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Mercy Health - Perrysburg Hospital

Perrysburg, Ohio, United States

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ProMedica Flower Hospital

Sylvania, Ohio, United States

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Mercy Health - Saint Anne Hospital

Toledo, Ohio, United States

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Toledo Clinic Cancer Centers-Toledo

Toledo, Ohio, United States

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University of Cincinnati Cancer Center-West Chester

West Chester, Ohio, United States

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University of Oklahoma Health Sciences Center

Oklahoma City, Oklahoma, United States

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Oklahoma Cancer Specialists and Research Institute-Tulsa

Tulsa, Oklahoma, United States

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Legacy Good Samaritan Hospital and Medical Center

Portland, Oregon, United States

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Providence Portland Medical Center

Portland, Oregon, United States

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Providence Saint Vincent Medical Center

Portland, Oregon, United States

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Kaiser Permanente Northwest

Portland, Oregon, United States

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Jefferson Abington Hospital

Abington, Pennsylvania, United States

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Lehigh Valley Hospital-Cedar Crest

Allentown, Pennsylvania, United States

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Bryn Mawr Hospital

Bryn Mawr, Pennsylvania, United States

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Geisinger Medical Center

Danville, Pennsylvania, United States

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UPMC Pinnacle Cancer Center/Community Osteopathic Campus

Harrisburg, Pennsylvania, United States

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Lancaster General Hospital

Lancaster, Pennsylvania, United States

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Paoli Memorial Hospital

Paoli, Pennsylvania, United States

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Allegheny General Hospital

Pittsburgh, Pennsylvania, United States

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University of Pittsburgh Cancer Institute (UPCI)

Pittsburgh, Pennsylvania, United States

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Guthrie Medical Group PC-Robert Packer Hospital

Sayre, Pennsylvania, United States

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Geisinger Wyoming Valley/Henry Cancer Center

Wilkes-Barre, Pennsylvania, United States

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UPMC Susquehanna

Williamsport, Pennsylvania, United States

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Lankenau Medical Center

Wynnewood, Pennsylvania, United States

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Rhode Island Hospital

Providence, Rhode Island, United States

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Prisma Health Cancer Institute - Spartanburg

Boiling Springs, South Carolina, United States

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Roper Hospital

Charleston, South Carolina, United States

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Charleston Oncology - Roper

Charleston, South Carolina, United States

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Lowcountry Hematology Oncology PA-North Charleston

Charleston, South Carolina, United States

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Bon Secours Saint Francis Hospital

Charleston, South Carolina, United States

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Charleston Oncology - Saint Francis

Charleston, South Carolina, United States

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Lowcountry Hematology Oncology PA-West Ashley

Charleston, South Carolina, United States

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Medical University of South Carolina

Charleston, South Carolina, United States

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Prisma Health Cancer Institute - Easley

Easley, South Carolina, United States

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Gibbs Cancer Center-Gaffney

Gaffney, South Carolina, United States

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Greenville Health System Cancer Institute-Andrews

Greenville, South Carolina, United States

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Saint Francis Hospital

Greenville, South Carolina, United States

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Prisma Health Cancer Institute - Butternut

Greenville, South Carolina, United States

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Prisma Health Cancer Institute - Faris

Greenville, South Carolina, United States

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Prisma Health Greenville Memorial Hospital

Greenville, South Carolina, United States

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Saint Francis Cancer Center

Greenville, South Carolina, United States

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Prisma Health Cancer Institute - Eastside

Greenville, South Carolina, United States

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Prisma Health Cancer Institute - Greer

Greer, South Carolina, United States

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Gibbs Cancer Center-Pelham

Greer, South Carolina, United States

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Lowcountry Hematology Oncology PA-Mount Pleasant

Mt. Pleasant, South Carolina, United States

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Prisma Health Cancer Institute - Seneca

Seneca, South Carolina, United States

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Spartanburg Medical Center

Spartanburg, South Carolina, United States

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Avera Cancer Institute-Aberdeen

Aberdeen, South Dakota, United States

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Rapid City Regional Hospital

Rapid City, South Dakota, United States

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Sanford Cancer Center Oncology Clinic

Sioux Falls, South Dakota, United States

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Avera Cancer Institute

Sioux Falls, South Dakota, United States

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Sanford USD Medical Center - Sioux Falls

Sioux Falls, South Dakota, United States

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Wellmont Holston Valley Hospital and Medical Center

Kingsport, Tennessee, United States

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University of Tennessee - Knoxville

Knoxville, Tennessee, United States

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Vanderbilt University/Ingram Cancer Center

Nashville, Tennessee, United States

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UT Southwestern/Simmons Cancer Center-Dallas

Dallas, Texas, United States

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Brooke Army Medical Center

Fort Sam Houston, Texas, United States

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Baylor College of Medicine/Dan L Duncan Comprehensive Cancer Center

Houston, Texas, United States

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Ben Taub General Hospital

Houston, Texas, United States

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M D Anderson Cancer Center

Houston, Texas, United States

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Memorial Hermann Texas Medical Center

Houston, Texas, United States

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Huntsman Cancer Institute/University of Utah

Salt Lake City, Utah, United States

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University of Vermont and State Agricultural College

Burlington, Vermont, United States

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University of Virginia Cancer Center

Charlottesville, Virginia, United States

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Danville Regional Medical Center

Danville, Virginia, United States

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Inova Fairfax Hospital

Falls Church, Virginia, United States

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MultiCare Auburn Medical Center

Auburn, Washington, United States

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PeaceHealth Saint Joseph Medical Center

Bellingham, Washington, United States

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Highline Medical Center-Main Campus

Burien, Washington, United States

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MultiCare Gig Harbor Medical Park

Gig Harbor, Washington, United States

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Jefferson Healthcare

Port Townsend, Washington, United States

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MultiCare Good Samaritan Hospital

Puyallup, Washington, United States

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Virginia Mason Medical Center

Seattle, Washington, United States

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Franciscan Research Center-Northwest Medical Plaza

Tacoma, Washington, United States

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MultiCare Tacoma General Hospital

Tacoma, Washington, United States

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Northwest Medical Specialties PLLC

Tacoma, Washington, United States

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PeaceHealth Southwest Medical Center

Vancouver, Washington, United States

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Edwards Comprehensive Cancer Center

Huntington, West Virginia, United States

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West Virginia University Healthcare

Morgantown, West Virginia, United States

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Aurora Cancer Care-Southern Lakes VLCC

Burlington, Wisconsin, United States

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HSHS Sacred Heart Hospital

Eau Claire, Wisconsin, United States

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Marshfield Clinic Cancer Center at Sacred Heart

Eau Claire, Wisconsin, United States

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Aurora Health Center-Fond du Lac

Fond du Lac, Wisconsin, United States

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Aurora Health Care Germantown Health Center

Germantown, Wisconsin, United States

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Aurora Cancer Care-Grafton

Grafton, Wisconsin, United States

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Saint Vincent Hospital Cancer Center Green Bay

Green Bay, Wisconsin, United States

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Saint Vincent Hospital Cancer Center at Saint Mary's

Green Bay, Wisconsin, United States

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Aurora BayCare Medical Center

Green Bay, Wisconsin, United States

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Mercyhealth Hospital and Cancer Center - Janesville

Janesville, Wisconsin, United States

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Gundersen Lutheran Medical Center

La Crosse, Wisconsin, United States

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University of Wisconsin Carbone Cancer Center - University Hospital

Madison, Wisconsin, United States

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Aurora Bay Area Medical Group-Marinette

Marinette, Wisconsin, United States

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Marshfield Medical Center-Marshfield

Marshfield, Wisconsin, United States

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Marshfield Medical Center

Marshfield, Wisconsin, United States

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Aurora Cancer Care-Milwaukee

Milwaukee, Wisconsin, United States

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Aurora Saint Luke's Medical Center

Milwaukee, Wisconsin, United States

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Medical College of Wisconsin

Milwaukee, Wisconsin, United States

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Aurora Sinai Medical Center

Milwaukee, Wisconsin, United States

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Marshfield Medical Center - Minocqua

Minocqua, Wisconsin, United States

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ProHealth D N Greenwald Center

Mukwonago, Wisconsin, United States

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ProHealth Oconomowoc Memorial Hospital

Oconomowoc, Wisconsin, United States

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Saint Vincent Hospital Cancer Center at Oconto Falls

Oconto Falls, Wisconsin, United States

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Vince Lombardi Cancer Clinic - Oshkosh

Oshkosh, Wisconsin, United States

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Aurora Cancer Care-Racine

Racine, Wisconsin, United States

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Lakeview Medical Center-Marshfield Clinic

Rice Lake, Wisconsin, United States

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Marshfield Medical Center-Rice Lake

Rice Lake, Wisconsin, United States

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Vince Lombardi Cancer Clinic-Sheboygan

Sheboygan, Wisconsin, United States

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Saint Vincent Hospital Cancer Center at Sturgeon Bay

Sturgeon Bay, Wisconsin, United States

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Aurora Medical Center in Summit

Summit, Wisconsin, United States

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Vince Lombardi Cancer Clinic-Two Rivers

Two Rivers, Wisconsin, United States

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Aurora Cancer Care-Waukesha

Waukesha, Wisconsin, United States

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ProHealth Waukesha Memorial Hospital

Waukesha, Wisconsin, United States

Site Status

UW Cancer Center at ProHealth Care

Waukesha, Wisconsin, United States

Site Status

Aurora Cancer Care-Milwaukee West

Wauwatosa, Wisconsin, United States

Site Status

Aurora West Allis Medical Center

West Allis, Wisconsin, United States

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Marshfield Medical Center - Weston

Weston, Wisconsin, United States

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Fundacion De Investigacion de Diego

San Juan, , Puerto Rico

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Countries

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United States Puerto Rico

References

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Sarkaria JN, Ballman KV, Kizilbash SH, Sulman EP, Giannini C, Friday BB, Butowski NA, Mohile NA, Piccioni DE, Battiste JD, Drappatz J, Campian JL, Mashru S, Jaeckle KA, O'Brien BJ, Dixon JG, Kabat BF, Laack NL, Hu LS, Kaufmann T, Kumthekar P, Ellingson BM, Anderson SK, Galanis E. Efficacy of Adding Veliparib to Temozolomide for Patients With MGMT-Methylated Glioblastoma: A Randomized Clinical Trial. JAMA Oncol. 2024 Dec 1;10(12):1637-1644. doi: 10.1001/jamaoncol.2024.4361.

Reference Type DERIVED
PMID: 39480453 (View on PubMed)

Gupta SK, Kizilbash SH, Carlson BL, Mladek AC, Boakye-Agyeman F, Bakken KK, Pokorny JL, Schroeder MA, Decker PA, Cen L, Eckel-Passow JE, Sarkar G, Ballman KV, Reid JM, Jenkins RB, Verhaak RG, Sulman EP, Kitange GJ, Sarkaria JN. Delineation of MGMT Hypermethylation as a Biomarker for Veliparib-Mediated Temozolomide-Sensitizing Therapy of Glioblastoma. J Natl Cancer Inst. 2015 Nov 27;108(5):djv369. doi: 10.1093/jnci/djv369. Print 2016 May.

Reference Type DERIVED
PMID: 26615020 (View on PubMed)

Provided Documents

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Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

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NCI-2014-00616

Identifier Type: REGISTRY

Identifier Source: secondary_id

A071102

Identifier Type: -

Identifier Source: secondary_id

CALGB-A071102

Identifier Type: -

Identifier Source: secondary_id

A071102

Identifier Type: OTHER

Identifier Source: secondary_id

A071102

Identifier Type: OTHER

Identifier Source: secondary_id

P50CA108961

Identifier Type: NIH

Identifier Source: secondary_id

View Link

U10CA031946

Identifier Type: NIH

Identifier Source: secondary_id

View Link

U10CA180821

Identifier Type: NIH

Identifier Source: secondary_id

View Link

NCI-2014-00616

Identifier Type: -

Identifier Source: org_study_id

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