Armodafinil in Reducing Cancer-Related Fatigue in Patients with High-Grade Glioma

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Basic Trial Information

PhaseTypeAgeTrial IDs
Phase IIISupportive care18 and overA221101
NCI-2012-02020, N10C3, NCT01781468

Trial Description

Summary

This randomized phase III trial studies how well armodafinil works in reducing cancer-related fatigue in patients with high-grade glioma. Armodafinil may help relieve fatigue in patients with high-grade glioma.

Further Study Information

PRIMARY OBJECTIVES:

I. To determine preliminary efficacy measured by patient reported fatigue (Brief Fatigue Inventory [BFI]) at 8 weeks of two doses (150 mg and 250 mg) of armodafinil in treating moderate fatigue compared to placebo in patients with high grade glioma.

SECONDARY OBJECTIVES:

I. To evaluate the tolerability at 8 weeks of 150 mg and 250 mg armodafinil in this patient population.

II. To assess the effect of armodafinil at 8 weeks on cognitive function in patients with high grade glioma.

III. To assess the impact of armodafinil on global quality of life and other fatigue endpoints in this patient population with high grade glioma.

IV. Explore the correlation between the BFI, Patient-Reported Outcomes Measurement Information System (PROMIS), and Patient-Reported Outcomes version of the Common Terminology Criteria for Adverse Events (PRO-CTCAE) measures, as well as the relationship of fatigue and cognitive difficulties.

OUTLINE: Patients are randomized to 1 of 3 treatment arms.

ARM I: Patients receive lower-dose armodafinil orally (PO) once daily (QD) on days 1-28.

ARM II: Patients receive placebo PO QD on days 1-28.

ARM III: Patients receive higher-dose armodafinil PO QD on days 1-28.

In all arms, treatment repeats every 28 days for 2 courses.

Eligibility Criteria

Inclusion Criteria:

Diagnosed with glioblastoma, gliosarcoma, small cell or large cell glioblastoma, glioblastoma with oligo features, glioblastoma with primitive neuroectodermal tumor-like components (GBM-PNET) features, anaplastic astrocytoma, anaplastic oligodendroglioma, or anaplastic oligoastrocytoma who are clinically stable and have completed radiation therapy > 21 days and =< 24 months prior to enrollment; NOTE: clinical stability will be defined as a stable or improved Karnofsky performance status (KPS) compared to the prior month

>= 6 score on the worst fatigue question of the BFI (Brief Fatigue Inventory, question 3)

Provide informed written consent

Eastern Cooperative Oncology Group (ECOG) performance status (PS) of 0, 1, 2 or 3

Stable dose of corticosteroid >= 14 days prior to registration

Willing to return to enrolling institution for follow-up (during the Active Monitoring Phase of the study)

Undergone surgery (gross total or subtotal resection) or biopsy and will have been treated with concurrent radiation therapy and chemotherapy as standard of care for glioblastoma, gliosarcoma, small cell or large cell glioblastoma, glioblastoma with oligo features, glioblastoma with primitive neuroectodermal tumor-like components (GBM-PNET) features, anaplastic astrocytoma, anaplastic oligodendroglioma, or anaplastic oligoastrocytoma patients; Note: radiation must be completed, but chemotherapy is allowed

Ability to complete questionnaire(s) by themselves or with assistance

Negative serum pregnancy test done =< 7 days prior to registration only for women determined to be of childbearing potential by their treating physician

Exclusion Criteria:

Any of the following co-morbid systemic illnesses or other severe concurrent disease which, in the judgment of the investigator, would make the patient inappropriate for entry into this study or interfere significantly with the proper assessment of safety and toxicity of the prescribed regimens:

History of myocardial infarction

Unstable angina

Left ventricular hypertrophy

Mitral valve prolapse syndrome

Receiving any medications or substances that are strong or moderate inhibitors of cytochrome P450 family 3, subfamily A, polypeptide 4 (CYP3A4); use of the following strong or moderate inhibitors are prohibited =< 7 days prior to registration

Strong Inhibitors of CYP3A4:

  • > 5-fold increase in the plasma area under the curve (AUC) values or more than 80% decrease in clearance
  • Indinavir (Crixivan)
  • Nelfinavir (Viracept)
  • Atazanavir (Reyataz)
  • Ritonavir (Norvir)
  • Clarithromycin (Biaxin, Biaxin XL)
  • Itraconazole (Sporanox)
  • Ketoconazole (Nizoral)
  • Nefazodone (Serzone)
  • Saquinavir (Fortovase, Invirase)
  • Telithromycin (Ketek)

Moderate Inhibitors of CYP3A4

  • > 2-fold increase in the plasma AUC values or 50-80% decrease in clearance
  • Aprepitant (Emend)
  • Erythromycin (Erythrocin, E.E.S., Ery-Tab, Eryc, EryPed, PCE)
  • Fluconazole (Diflucan)
  • Grapefruit juice
  • Verapamil (Calan, Calan SR, Covera-HS, Isoptin SR, Verelan, Verelan PM)
  • Diltiazem (Cardizem, Cardizem CD, Cardizem LA, Cardizem SR, Cartia XT, Dilacor XR, Diltia XT, Taztia XT, Tiazac)

Currently using any other pharmacologic agents or nonpharmacologic interventions to specifically treat fatigue, including psychostimulants, antidepressants, acupuncture, etc. will be excluded; Note: antidepressants used to treat items other than fatigue (such as hot flashes or depression) are allowed if the patient has been on a stable dose for >= 30 days and plans to continue for the duration of the trial; erythropoietin agents to treat anemia are allowed; exercise is allowed

History of hypersensitivity to other psychostimulants

History of steroid psychosis

History of or currently taking medications for attention deficit hyperactivity disorder, severe anxiety disorder, schizophrenia, or substance abuse by patient record and/or self-report

History of or active glaucoma

History of intractable epilepsy, or uncontrolled seizure disorder

Receiving any medications or substances that are inducers of CYP3A4; use of the following inducers are prohibited =< 7 days prior to registration

Inducers of CYP3A4

  • Efavirenz (Sustiva)
  • Nevirapine (Viramune)
  • Carbamazepine (Carbatro, Epitol, Equetro, Tegretol, Tegretol-XR)
  • Modafinil (Provigil)
  • Phenobarbital (Luminal)
  • Phenytoin (Dilantin, Phenytek)
  • Pioglitazone (Acto)
  • Rifabutin (Mycobutin)
  • Rifampin (Rifadin)
  • St. John’s wort

Active or a history of Tourette’s syndrome or tic disorder

Anticipating surgery, laboratory evidence of hypothyroidism with an elevated thyroid-stimulating hormone (TSH) concentration in the blood > 5.0 mlU/L, profound anemia (hemoglobin level of < 10 g/dL =< 28 days prior to registration), or clinical depression per physician discretion

Any of the following:

Pregnant women

Nursing women

Men or women of childbearing potential who are unwilling to employ adequate contraception

Trial Contact Information

Trial Lead Organizations / Sponsors / Collaborators

Alliance for Clinical Trials in Oncology

  • National Cancer Institute
Alyx B. Porter Umphrey, Principal Investigator

Trial Sites

U.S.A.

Arizona
Phoenix

Arizona Oncology-Deer Valley Center

David G. Brachman
Ph: 877-602-4111

David G. Brachman
Principal Investigator

Scottsdale

Arizona Oncology Services Foundation

David G. Brachman
Ph: 877-602-4111

David G. Brachman
Principal Investigator

Mayo Clinic in Arizona

Alyx B. Porter Umphrey
Ph: 507-538-7623

Alyx B. Porter Umphrey
Principal Investigator

California
Concord

John Muir Medical Center-Concord Campus

Marjaneh Moini
Ph: 925-674-2580

Marjaneh Moini
Principal Investigator

La Jolla

UC San Diego Moores Cancer Center

Santosh Kesari
Ph: 858-822-5354
Email: cancercto@ucsd.edu

Santosh Kesari
Principal Investigator

Orange

Saint Joseph Hospital - Orange

Hector Wanhow Ho
Ph: 714-734-6220

Hector Wanhow Ho
Principal Investigator

UC Irvine Health/Chao Family Comprehensive Cancer Center

Jose A. Carrillo
Ph: 877-827-8839
Email: ucstudy@uci.edu

Jose A. Carrillo
Principal Investigator

Colorado
Colorado Springs

Penrose-Saint Francis Healthcare

Keren Sturtz
Ph: 888-785-6789

Keren Sturtz
Principal Investigator

Rocky Mountain Cancer Centers-Penrose

Keren Sturtz
Ph: 888-785-6789

Keren Sturtz
Principal Investigator

Wheat Ridge

Exempla Lutheran Medical Center

Keren Sturtz
Ph: 888-785-6789

Keren Sturtz
Principal Investigator

Delaware
Newark

Christiana Care Health System-Christiana Hospital

Stephen Scott Grubbs
Ph: 302-733-6227

Stephen Scott Grubbs
Principal Investigator

Helen F Graham Cancer Center

Stephen Scott Grubbs
Ph: 302-733-6227

Stephen Scott Grubbs
Principal Investigator

Medical Oncology Hematology Consultants PA

Stephen Scott Grubbs
Ph: 302-733-6227

Stephen Scott Grubbs
Principal Investigator

Regional Hematology and Oncology PA

Stephen Scott Grubbs
Ph: 302-733-6227

Stephen Scott Grubbs
Principal Investigator

Florida
Daytona Beach

Florida Hospital Memorial Medical Center

Mudussara Asad Khan
Ph: 386-676-6025

Mudussara Asad Khan
Principal Investigator

Lakeland

Lakeland Regional Cancer Center

Madhavi L. Venigalla
Ph: 863-904-1900

Madhavi L. Venigalla
Principal Investigator

Pensacola

Sacred Heart Hospital

Thomas Dean Sunnenberg
Ph: 850-416-4611

Thomas Dean Sunnenberg
Principal Investigator

Sacred Heart Medical Oncology Group - Davis Highway

Thomas Dean Sunnenberg
Ph: 850-416-4611

Thomas Dean Sunnenberg
Principal Investigator

Georgia
Atlanta

Piedmont Hospital

Erin M. Dunbar
Ph: 404-425-7943
Email: ORS@piedmont.org

Erin M. Dunbar
Principal Investigator

Gainesville

Northeast Georgia Medical Center

Kendal Pierce Dixon
Ph: 770-219-8800
Email: cancerpatient.navigator@nghs.com

Kendal Pierce Dixon
Principal Investigator

Hawaii
Aiea

Oncare Hawaii Inc-Pali Momi

Jeffrey L. Berenberg
Ph: 808-586-2979

Jeffrey L. Berenberg
Principal Investigator

Pali Momi Medical Center

Jeffrey L. Berenberg
Ph: 808-586-2979

Jeffrey L. Berenberg
Principal Investigator

Ewa Beach

The Cancer Center of Hawaii-Leeward

Jeffrey L. Berenberg
Ph: 808-586-2979

Jeffrey L. Berenberg
Principal Investigator

Honolulu

Oncare Hawaii Inc-Kuakini

Jeffrey L. Berenberg
Ph: 808-586-2979

Jeffrey L. Berenberg
Principal Investigator

Oncare Hawaii Inc-POB II

Jeffrey L. Berenberg
Ph: 808-586-2979

Jeffrey L. Berenberg
Principal Investigator

OnCare Hawaii-Liliha

Jeffrey L. Berenberg
Ph: 808-586-2979

Jeffrey L. Berenberg
Principal Investigator

Queen's Medical Center

Jeffrey L. Berenberg
Ph: 808-586-2979

Jeffrey L. Berenberg
Principal Investigator

Straub Clinic and Hospital

Jeffrey L. Berenberg
Ph: 808-586-2979

Jeffrey L. Berenberg
Principal Investigator

The Cancer Center of Hawaii-Liliha

Jeffrey L. Berenberg
Ph: 808-586-2979

Jeffrey L. Berenberg
Principal Investigator

University of Hawaii Cancer Center

Jeffrey L. Berenberg
Ph: 808-586-2979

Jeffrey L. Berenberg
Principal Investigator

Idaho
Boise

Saint Alphonsus Cancer Care Center-Boise

Samir Narayan
Ph: 734-712-4673

Samir Narayan
Principal Investigator

Coeur D'Alene

Kootenai Medical Center

Benjamin T. Marchello
Ph: 800-648-6274

Benjamin T. Marchello
Principal Investigator

Post Falls

Kootenai Cancer Center

Benjamin T. Marchello
Ph: 800-648-6274

Benjamin T. Marchello
Principal Investigator

Illinois
Bloomington

Illinois CancerCare-Bloomington

James Lloyd Wade
Ph: 217-876-4740
Email: kcheek@dmhhs.org

James Lloyd Wade
Principal Investigator

Canton

Illinois CancerCare-Canton

James Lloyd Wade
Ph: 217-876-4740
Email: kcheek@dmhhs.org

James Lloyd Wade
Principal Investigator

Carthage

Illinois CancerCare-Carthage

James Lloyd Wade
Ph: 217-876-4740
Email: kcheek@dmhhs.org

James Lloyd Wade
Principal Investigator

Centralia

Centralia Oncology Clinic

James Lloyd Wade
Ph: 217-876-4740
Email: kcheek@dmhhs.org

James Lloyd Wade
Principal Investigator

Decatur

Cancer Care Center of Decatur

James Lloyd Wade
Ph: 217-876-4740
Email: kcheek@dmhhs.org

James Lloyd Wade
Principal Investigator

Decatur Memorial Hospital

James Lloyd Wade
Ph: 217-876-4740
Email: kcheek@dmhhs.org

James Lloyd Wade
Principal Investigator

Effingham

Crossroads Cancer Center

James Lloyd Wade
Ph: 217-876-4740
Email: kcheek@dmhhs.org

James Lloyd Wade
Principal Investigator

Eureka

Illinois CancerCare-Eureka

James Lloyd Wade
Ph: 217-876-4740
Email: kcheek@dmhhs.org

James Lloyd Wade
Principal Investigator

Evanston

NorthShore University HealthSystem-Evanston Hospital

Ryan Thomas Merrell
Ph: 847-570-2109

Ryan Thomas Merrell
Principal Investigator

Galesburg

Illinois CancerCare Galesburg

James Lloyd Wade
Ph: 217-876-4740
Email: kcheek@dmhhs.org

James Lloyd Wade
Principal Investigator

Glenview

NorthShore University HealthSystem-Glenbrook Hospital

Ryan Thomas Merrell
Ph: 847-570-2109

Ryan Thomas Merrell
Principal Investigator

Highland Park

NorthShore University HealthSystem-Highland Park Hospital

Ryan Thomas Merrell
Ph: 847-570-2109

Ryan Thomas Merrell
Principal Investigator

Kewanee

Illinois CancerCare-Kewanee Clinic

James Lloyd Wade
Ph: 217-876-4740
Email: kcheek@dmhhs.org

James Lloyd Wade
Principal Investigator

Macomb

Illinois CancerCare-Macomb

James Lloyd Wade
Ph: 217-876-4740
Email: kcheek@dmhhs.org

James Lloyd Wade
Principal Investigator

Ottawa

Illinois CancerCare-Ottawa Clinic

James Lloyd Wade
Ph: 217-876-4740
Email: kcheek@dmhhs.org

James Lloyd Wade
Principal Investigator

Pekin

Illinois CancerCare-Pekin

James Lloyd Wade
Ph: 217-876-4740
Email: kcheek@dmhhs.org

James Lloyd Wade
Principal Investigator

Peoria

Illinois CancerCare-Peoria

Nguyet Anh Le-Lindqwister
Ph: 800-793-2262

Nguyet Anh Le-Lindqwister
Principal Investigator

Methodist Medical Center of Illinois

James Lloyd Wade
Ph: 217-876-4740
Email: kcheek@dmhhs.org

James Lloyd Wade
Principal Investigator

OSF Saint Francis Medical Center

James Lloyd Wade
Ph: 217-876-4740
Email: kcheek@dmhhs.org

James Lloyd Wade
Principal Investigator

Peru

Illinois CancerCare-Peru

James Lloyd Wade
Ph: 217-876-4740
Email: kcheek@dmhhs.org

James Lloyd Wade
Principal Investigator

Princeton

Illinois CancerCare-Princeton

James Lloyd Wade
Ph: 217-876-4740
Email: kcheek@dmhhs.org

James Lloyd Wade
Principal Investigator

Springfield

Memorial Medical Center

James Lloyd Wade
Ph: 217-876-4740
Email: kcheek@dmhhs.org

James Lloyd Wade
Principal Investigator

Southern Illinois University School of Medicine

James Lloyd Wade
Ph: 217-876-4740
Email: kcheek@dmhhs.org

James Lloyd Wade
Principal Investigator

Springfield Clinic

James Lloyd Wade
Ph: 217-876-4740
Email: kcheek@dmhhs.org

James Lloyd Wade
Principal Investigator

Warrenville

Cadence Cancer Center in Warrenville

Sean A. Grimm
Ph: 630-352-5300

Sean A. Grimm
Principal Investigator

Indiana
Elkhart

Michiana Hematology Oncology PC-Elkhart

Robin T. Zon
Ph: 574-234-5123

Robin T. Zon
Principal Investigator

Mishawaka

Michiana Hematology Oncology PC-Mishawaka

Robin T. Zon
Ph: 574-234-5123

Robin T. Zon
Principal Investigator

Saint Joseph Regional Medical Center-Mishawaka

Robin T. Zon
Ph: 574-234-5123

Robin T. Zon
Principal Investigator

Plymouth

Michiana Hematology Oncology PC-Plymouth

Robin T. Zon
Ph: 574-234-5123

Robin T. Zon
Principal Investigator

South Bend

Memorial Hospital of South Bend

Thomas Joseph Reid
Ph: 800-284-7370

Thomas Joseph Reid
Principal Investigator

Michiana Hematology Oncology PC-South Bend

Robin T. Zon
Ph: 574-234-5123

Robin T. Zon
Principal Investigator

Northern Indiana Cancer Research Consortium CCOP

Robin T. Zon
Ph: 574-234-5123

Robin T. Zon
Principal Investigator

Westville

Michiana Hematology Oncology PC-Westville

Robin T. Zon
Ph: 574-234-5123

Robin T. Zon
Principal Investigator

Iowa
Ames

Mary Greeley Medical Center

Joseph James Merchant
Ph: 515-239-2621

Joseph James Merchant
Principal Investigator

McFarland Clinic PC-William R Bliss Cancer Center

Joseph James Merchant
Ph: 515-239-2621

Joseph James Merchant
Principal Investigator

Cedar Rapids

Mercy Hospital

Deborah Weil Wilbur
Ph: 319-363-2690

Deborah Weil Wilbur
Principal Investigator

Oncology Associates at Mercy Medical Center

Deborah Weil Wilbur
Ph: 319-363-2690

Deborah Weil Wilbur
Principal Investigator

Mason City

Mercy Medical Center - North Iowa

Arvind Y. Vemula
Ph: 800-433-3883

Arvind Y. Vemula
Principal Investigator

Kansas
Chanute

Cancer Center of Kansas - Chanute

Shaker R. Dakhil
Ph: 316-262-4467

Shaker R. Dakhil
Principal Investigator

Dodge City

Cancer Center of Kansas - Dodge City

Shaker R. Dakhil
Ph: 316-262-4467

Shaker R. Dakhil
Principal Investigator

El Dorado

Cancer Center of Kansas - El Dorado

Shaker R. Dakhil
Ph: 316-262-4467

Shaker R. Dakhil
Principal Investigator

Fort Scott

Cancer Center of Kansas - Fort Scott

Shaker R. Dakhil
Ph: 316-262-4467

Shaker R. Dakhil
Principal Investigator

Independence

Cancer Center of Kansas-Independence

Shaker R. Dakhil
Ph: 316-262-4467

Shaker R. Dakhil
Principal Investigator

Kingman

Cancer Center of Kansas-Kingman

Shaker R. Dakhil
Ph: 316-262-4467

Shaker R. Dakhil
Principal Investigator

Lawrence

Lawrence Memorial Hospital

Shaker R. Dakhil
Ph: 316-262-4467

Shaker R. Dakhil
Principal Investigator

Liberal

Cancer Center of Kansas-Liberal

Shaker R. Dakhil
Ph: 316-262-4467

Shaker R. Dakhil
Principal Investigator

Newton

Cancer Center of Kansas - Newton

Shaker R. Dakhil
Ph: 316-262-4467

Shaker R. Dakhil
Principal Investigator

Parsons

Cancer Center of Kansas - Parsons

Shaker R. Dakhil
Ph: 316-262-4467

Shaker R. Dakhil
Principal Investigator

Pratt

Cancer Center of Kansas - Pratt

Shaker R. Dakhil
Ph: 316-262-4467

Shaker R. Dakhil
Principal Investigator

Salina

Cancer Center of Kansas - Salina

Shaker R. Dakhil
Ph: 316-262-4467

Shaker R. Dakhil
Principal Investigator

Wellington

Cancer Center of Kansas - Wellington

Shaker R. Dakhil
Ph: 316-262-4467

Shaker R. Dakhil
Principal Investigator

Wichita

Associates In Womens Health

Shaker R. Dakhil
Ph: 316-262-4467

Shaker R. Dakhil
Principal Investigator

Cancer Center of Kansas - Main Office

Shaker R. Dakhil
Ph: 316-262-4467

Shaker R. Dakhil
Principal Investigator

Cancer Center of Kansas-Wichita Medical Arts Tower

Shaker R. Dakhil
Ph: 316-262-4467

Shaker R. Dakhil
Principal Investigator

Via Christi Regional Medical Center

Shaker R. Dakhil
Ph: 316-262-4467

Shaker R. Dakhil
Principal Investigator

Winfield

Cancer Center of Kansas - Winfield

Shaker R. Dakhil
Ph: 316-262-4467

Shaker R. Dakhil
Principal Investigator

Kentucky
Lexington

Baptist Health Lexington

Firas B. Badin
Ph: 859-260-6425

Firas B. Badin
Principal Investigator

University of Kentucky/Markey Cancer Center

John Lee Villano
Ph: 859-257-3379

John Lee Villano
Principal Investigator

Maine
Lewiston

Central Maine Medical Center

David Clark Caldwell
Ph: 207-795-8250
Email: benderli@cmhc.org

David Clark Caldwell
Principal Investigator

Maryland
Rockville

Unspecified Site

Alyx B. Porter Umphrey
Ph: 507-266-5230
Email: porter.alyx@mayo.edu

Alyx B. Porter Umphrey
Principal Investigator

Massachusetts
Boston

Boston Medical Center

Ken S. Zaner
Ph: 617-638-8265

Ken S. Zaner
Principal Investigator

Tufts Medical Center

Suriya Jeyapalan
Ph: 617-636-5000
Email: ContactUsCancerCenter@TuftsMedicalCenter.org

Suriya Jeyapalan
Principal Investigator

Michigan
Ann Arbor

Saint Joseph Mercy Hospital

Samir Narayan
Ph: 734-712-4673

Samir Narayan
Principal Investigator

Battle Creek

Bronson Battle Creek

Gilbert D.A. Padula
Ph: 616-685-5225
Email: connie.szczepanek@grcop.org

Gilbert D.A. Padula
Principal Investigator

Detroit

Saint John Hospital and Medical Center

Samir Narayan
Ph: 734-712-4673

Samir Narayan
Principal Investigator

Grand Rapids

Mercy Health Saint Mary's

Gilbert D.A. Padula
Ph: 616-685-5225
Email: connie.szczepanek@grcop.org

Gilbert D.A. Padula
Principal Investigator

Spectrum Health at Butterworth Campus

Gilbert D.A. Padula
Ph: 616-685-5225
Email: connie.szczepanek@grcop.org

Gilbert D.A. Padula
Principal Investigator

Kalamazoo

West Michigan Cancer Center

Raymond Sterling Lord
Ph: 269-373-7458

Raymond Sterling Lord
Principal Investigator

Saginaw

Saint Mary's of Michigan

Samir Narayan
Ph: 734-712-4673

Samir Narayan
Principal Investigator

Saint Joseph

Marie Yeager Cancer Center

Robin T. Zon
Ph: 574-234-5123

Robin T. Zon
Principal Investigator

Southfield

Providence Hospital

Susan Elizabeth Lyons
Ph: 248-849-5337
Email: jaswinder.grewal@stjohn.org

Susan Elizabeth Lyons
Principal Investigator

St. Joseph

Lakeland Hospital

Robin T. Zon
Ph: 574-234-5123

Robin T. Zon
Principal Investigator

Warren

Saint John Macomb-Oakland Hospital

Samir Narayan
Ph: 734-712-4673

Samir Narayan
Principal Investigator

Minnesota
Duluth

Essentia Health Cancer Center

Bret E.B. Friday
Ph: 888-203-7267

Bret E.B. Friday
Principal Investigator

Rochester

Mayo Clinic

Alyx B. Porter Umphrey
Ph: 507-538-7623

Alyx B. Porter Umphrey
Principal Investigator

Missouri
Bolivar

Central Care Cancer Center-Carrie J Babb Cancer Center

Jay W. Carlson
Ph: 800-821-7532

Jay W. Carlson
Principal Investigator

Chesterfield

Saint Luke's Hospital

Donald F. Busiek
Ph: 314-205-6936

Donald F. Busiek
Principal Investigator

Joplin

Freeman Health System

Jay W. Carlson
Ph: 800-821-7532

Jay W. Carlson
Principal Investigator

Saint Louis

Washington University School of Medicine

Jian Li Campian
Ph: 800-600-3606
Email: info@siteman.wustl.edu

Jian Li Campian
Principal Investigator

Springfield

Mercy Hospital Springfield

Jay W. Carlson
Ph: 800-821-7532

Jay W. Carlson
Principal Investigator

Montana
Billings

Billings Clinic Cancer Center

Benjamin T. Marchello
Ph: 800-648-6274

Benjamin T. Marchello
Principal Investigator

Montana Cancer Consortium CCOP

Benjamin T. Marchello
Ph: 800-648-6274

Benjamin T. Marchello
Principal Investigator

Nebraska
Lincoln

Nebraska Cancer Research Center

Gamini S. Soori
Ph: 402-280-4100

Gamini S. Soori
Principal Investigator

Nevada
Las Vegas

Nevada Cancer Research Foundation CCOP

John Allan Ellerton
Ph: 702-384-0013

John Allan Ellerton
Principal Investigator

New Hampshire
Concord

New Hampshire Oncology Hematology PA-Concord

Douglas J. Weckstein
Ph: 603-224-2556

Douglas J. Weckstein
Principal Investigator

Hooksett

New Hampshire Oncology Hematology PA-Hooksett

Douglas J. Weckstein
Ph: 603-224-2556

Douglas J. Weckstein
Principal Investigator

Laconia

LRGHealthcare-Lakes Region General Hospital

Douglas J. Weckstein
Ph: 603-224-2556

Douglas J. Weckstein
Principal Investigator

Lebanon

Dartmouth Hitchcock Medical Center

Camilo Enrique Fadul
Ph: 800-639-6918
Email: cancer.research.nurse@dartmouth.edu

Camilo Enrique Fadul
Principal Investigator

New Jersey
Somerville

Robert Wood Johnson University Hospital Somerset

James M. Chimenti
Ph: 908-685-2481

James M. Chimenti
Principal Investigator

New York
East Syracuse

Hematology Oncology Associates of Central New York-East Syracuse

Jeffrey J. Kirshner
Ph: 315-472-7504

Jeffrey J. Kirshner
Principal Investigator

New York

Memorial Sloan-Kettering Cancer Center

Eli L. Diamond
Ph: 212-639-7202

Eli L. Diamond
Principal Investigator

Rochester

Highland Hospital

Yuhchyau Chen
Ph: 585-275-5830

Yuhchyau Chen
Principal Investigator

University of Rochester

Yuhchyau Chen
Ph: 585-275-5830

Yuhchyau Chen
Principal Investigator

University Radiation Oncology

Yuhchyau Chen
Ph: 585-275-5830

Yuhchyau Chen
Principal Investigator

North Carolina
Goldsboro

Wayne Memorial Hospital

James N. Atkins
Ph: 919-580-0000

James N. Atkins
Principal Investigator

Kinston

Kinston Medical Specialists PA

Peter Robins Watson
Ph: 252-559-2200

Peter Robins Watson
Principal Investigator

North Dakota
Grand Forks

Altru Cancer Center

Grant Richard Seeger
Ph: 701-780-6520

Grant Richard Seeger
Principal Investigator

Ohio
Akron

Akron General Medical Center

Esther Hoogland Rehmus
Ph: 330-344-6348

Esther Hoogland Rehmus
Principal Investigator

Columbus

Riverside Methodist Hospital

John Philip Kuebler
Ph: 614-566-3275

John Philip Kuebler
Principal Investigator

Toledo

Mercy Saint Anne Hospital

Rex B. Mowat
Ph: 800-444-3561

Rex B. Mowat
Principal Investigator

Toledo Clinic Cancer Centers-Toledo

Rex B. Mowat
Ph: 800-444-3561

Rex B. Mowat
Principal Investigator

Oklahoma
Oklahoma City

University of Oklahoma Health Sciences Center

James Douglas Battiste
Ph: 405-271-4272
Email: julie-traylor@ouhsc.edu

James Douglas Battiste
Principal Investigator

Tulsa

Saint John Medical Center

Coty Ho
Ph: 918-744-2685

Coty Ho
Principal Investigator

Oregon
Gresham

Legacy Mount Hood Medical Center

Regan Mon Look
Ph: 503-280-1223

Regan Mon Look
Principal Investigator

Portland

Kaiser Permanente

Nagendra Ranganatha Tirumali
Ph: 503-335-2400

Nagendra Ranganatha Tirumali
Principal Investigator

Legacy Good Samaritan Hospital and Medical Center

Regan Mon Look
Ph: 503-280-1223

Regan Mon Look
Principal Investigator

Tualatin

Legacy Meridian Park Hospital

Regan Mon Look
Ph: 503-280-1223

Regan Mon Look
Principal Investigator

Pennsylvania
Allentown

Lehigh Valley Hospital-Cedar Crest

Suresh G. Nair
Ph: 610-402-2273

Suresh G. Nair
Principal Investigator

Danville

Geisinger Medical Center

Scott G. Turner
Ph: 570-271-5251

Scott G. Turner
Principal Investigator

Gettysburg

Adams Cancer Center

Amir Tabatabai
Ph: 877-441-7957

Amir Tabatabai
Principal Investigator

Hanover

Cherry Tree Cancer Center

Amir Tabatabai
Ph: 877-441-7957

Amir Tabatabai
Principal Investigator

Wilkes-Barre

Geisinger Wyoming Valley/Henry Cancer Center

Scott G. Turner
Ph: 570-271-5251

Scott G. Turner
Principal Investigator

York

WellSpan Health-York Hospital

Amir Tabatabai
Ph: 877-441-7957

Amir Tabatabai
Principal Investigator

South Carolina
Easley

Greenville Health System Cancer Institute-Easley

David Lawrence Grisell
Ph: 864-241-6251

David Lawrence Grisell
Principal Investigator

Greenville

Greenville Health System Cancer Institute-Andrews

David Lawrence Grisell
Ph: 864-241-6251

David Lawrence Grisell
Principal Investigator

Greenville Health System Cancer Institute-Butternut

David Lawrence Grisell
Ph: 864-241-6251

David Lawrence Grisell
Principal Investigator

Greenville Health System Cancer Institute-Eastside

David Lawrence Grisell
Ph: 864-241-6251

David Lawrence Grisell
Principal Investigator

Greenville Health System Cancer Institute-Faris

David Lawrence Grisell
Ph: 864-241-6251

David Lawrence Grisell
Principal Investigator

Greer

Gibbs Cancer Center-Pelham

James Dewitt Bearden
Ph: 800-486-5941

James Dewitt Bearden
Principal Investigator

Greenville Health System Cancer Institute-Greer

David Lawrence Grisell
Ph: 864-241-6251

David Lawrence Grisell
Principal Investigator

Seneca

Greenville Health System Cancer Institute-Seneca

David Lawrence Grisell
Ph: 864-241-6251

David Lawrence Grisell
Principal Investigator

Spartanburg

Greenville Health System Cancer Institute-Spartanburg

David Lawrence Grisell
Ph: 864-241-6251

David Lawrence Grisell
Principal Investigator

Spartanburg Medical Center

James Dewitt Bearden
Ph: 800-486-5941

James Dewitt Bearden
Principal Investigator

South Dakota
Aberdeen

Avera Saint Luke's Hospital and Cancer Center

Addison R. Tolentino
Ph: 800-657-4377
Email: Jan.Healy@avera.org

Addison R. Tolentino
Principal Investigator

Rapid City

Rapid City Regional Hospital

Mark Thomas Schroeder
Ph: 605-716-3982
Email: research@rcrh.org

Mark Thomas Schroeder
Principal Investigator

Sioux Falls

Avera Cancer Institute

Amy K. Krie
Ph: 800-657-4377
Email: Jan.Healy@avera.org

Amy K. Krie
Principal Investigator

Texas
San Antonio

University of Texas Health Science Center at San Antonio

Andrew Jacob Brenner
Ph: 210-450-3800

Andrew Jacob Brenner
Principal Investigator

Utah
Salt Lake City

Huntsman Cancer Institute/University of Utah

Howard Colman
Ph: 801-581-4477
Email: clinical.trials@hci.utah.edu

Howard Colman
Principal Investigator

Washington
Puyallup

MultiCare Good Samaritan Hospital

John A. Keech
Ph: 907-458-5380

John A. Keech
Principal Investigator

Tacoma

Multicare Health System

John A. Keech
Ph: 907-458-5380

John A. Keech
Principal Investigator

Vancouver

Legacy Salmon Creek Hospital

Regan Mon Look
Ph: 503-280-1223

Regan Mon Look
Principal Investigator

West Virginia
Morgantown

West Virginia University Healthcare

Javier Gonzalez
Ph: 304-293-2745
Email: sfilburn@hsc.wvu.edu

Javier Gonzalez
Principal Investigator

Wisconsin
Green Bay

Green Bay Oncology at Saint Vincent Hospital

Anthony John Jaslowski
Ph: 800-432-6049

Anthony John Jaslowski
Principal Investigator

Green Bay Oncology Limited at Saint Mary's Hospital

Anthony John Jaslowski
Ph: 800-432-6049

Anthony John Jaslowski
Principal Investigator

Saint Vincent Hospital

Anthony John Jaslowski
Ph: 800-432-6049

Anthony John Jaslowski
Principal Investigator

La Crosse

Gundersen Lutheran Medical Center

Michael O Ojelabi
Ph: 608-775-2385
Email: cancerctr@gundluth.org

Michael O Ojelabi
Principal Investigator

Manitowoc

Holy Family Memorial Hospital

Anthony John Jaslowski
Ph: 800-432-6049

Anthony John Jaslowski
Principal Investigator

Milwaukee

Aurora Saint Luke's Medical Center

Ali K. Choucair
Ph: 414-649-5717

Ali K. Choucair
Principal Investigator

Froedtert and the Medical College of Wisconsin

Jennifer M. Connelly
Ph: 414-805-4380

Jennifer M. Connelly
Principal Investigator

Link to the current ClinicalTrials.gov record.
NLM Identifer NCT01781468

Note: Information about participating sites on pharmaceutical industry trials may be incomplete. Please visit the ClinicalTrials.gov record via the link above for more information about participating sites.