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

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Basic Trial Information

PhaseTypeStatusAgeSponsorProtocol IDs
Phase IIISupportive careActive18 and overNCI, OtherA221101
N10C3, NCI-2012-02020, U10CA031946, NCT01781468

Trial Description

Summary

This randomized phase III trial studies armodafinil to see how well it 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

Patients experiencing fatigue related to cancer will be asked to take part in this study. Cancer-related fatigue is a very common symptom in patients with cancer. Patients will receive armodafinil or placebo. Please see the "Arms" section for more details regarding the treatment assignments. The primary objective of this study is 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.

The secondary objectives of the study are listed below.

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

2. To assess the effect of armodafinil at 8 weeks on cognitive function in patients with glioblastoma.

3. To assess the impact of armodafinil on global quality of life and other fatigue endpoints (i.e. usual fatigue, activity interference) in this patient population with high grade glioma.

4. 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.

Patients will receive armodafinil or placebo for a total of 8 weeks.

Eligibility Criteria

Inclusion Criteria:

  • Age ≥ 18 years
  • 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)
  • 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 per the second eligibility criteria, but chemotherapy is allowed.

  • Negative serum pregnancy test done ≤ 7 days prior to registration only for women determined to be of childbearing potential by the treating physician.
  • Ability to complete questionnaire(s) by themselves or with assistance
  • Eastern Cooperative Oncology Group (ECOG) Performance Status (PS) of 0, 1, 2 or 3
  • Provide informed written consent
  • Willing to return to enrolling institution for follow-up (during the Active Monitoring Phase of the study)
  • Stable dose of corticosteroid ≥ 14 days prior to registration

Exclusion Criteria:

  • Pregnant women, nursing women, men or women of childbearing potential who are unwilling to employ adequate contraception since this study involves an investigational agent whose genotoxic, mutagenic and teratogenic effects on the developing fetus and newborn are unknown.
  • 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
  • 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.
  • 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
  • Active or a history of Tourrette's syndrome or tic disorder
  • History of or active glaucoma
  • History of intractable epilepsy, or uncontrolled seizure disorder
  • 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:

1. History of myocardial infarction

2. Unstable angina

3. Left ventricular hypertrophy

4. Mitral valve prolapse syndrome

  • Receiving any medications or substances that are strong or moderate inhibitors of cytochrome P450 3A4 (CYP3A4). Use of the following strong or moderate inhibitors are prohibited ≤ 7 days prior to registration:

1. Strong Inhibitors of CYP3A4: > 5-fold increase in the plasma area under the curve (AUC) values or more than 80% decrease in clearance :

1. Indinavir (Crixivan®)

2. Nelfinavir (Viracept®)

3. Atazanavir (Reyataz®)

4. Ritonavir (Norvir®)

5. Clarithromycin (Biaxin®, Biaxin XL®)

6. Itraconazole (Sporanox®)

7. Ketoconazole (Nizoral®)

8. Nefazodone (Serzone®)

9. Saquinavir (Fortovase®, Invirase®)

10. Telithromycin (Ketek®)

2. Moderate Inhibitors of CYP3A4 : > 2-fold increase in the plasma AUC values or 50-80% decrease in clearance :

1. Aprepitant (Emend®)

2. Erythromycin (Erythrocin®, E.E.S. ®, Ery-Tab®, Eryc®, EryPed®, PCE® )

3. Fluconazole (Diflucan®)

4. Grapefruit juice

5. Verapamil (Calan®, Calan SR®, Covera-HS®, Isoptin SR®, Verelan®, Verelan PM®)

6. Diltiazem (Cardizem®, Cardizem CD®, Cardizem LA®, Cardizem SR®, Cartia XT™) Dilacor XR®, Diltia XT®, Taztia XT™, Tiazac®)

  • Receiving any medications or substances that are inducers of CYP3A4. Use of the following inducers are prohibited ≤ 7 days prior to registration: Efavirenz (Sustiva®) , Nevirapine (Viramune®) , Carbamazepine (Carbatrol®, Epitol®, Equetro™, Tegretol®, Tegretol-XR®) , Modafinil (Provigil®) , Phenobarbital (Luminal®), Phenytoin (Dilantin®, Phenytek®) , Pioglitazone (Actos®) , Rifabutin (Mycobutin®) , Rifampin (Rifadin®) and St. John's Wort

Trial Contact Information

Trial Lead Organizations/Sponsors

Alliance for Clinical Trials in Oncology

  • National Cancer Institute
Alyx B. Porter Umphrey, M.D., Study Chair

Trial Sites

U.S.A.

Arizona
Scottsdale

Arizona Oncology Services Foundation

David G. Brachman
Ph: 877-602-4111

Mayo Clinic Scottsdale

Alyx B Umphrey
Ph: 507-538-7623

California
Concord

Cancer Care Center at John Muir Health - Concord Campus

Marjaneh Moini
Ph: 925-674-2580

La Jolla

Rebecca and John Moores UCSD Cancer Center

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

Orange

Chao Family Comprehensive Cancer Center at University of California Irvine Medical Center

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

St. Joseph Hospital Regional Cancer Center - Orange

Hector W Ho
Ph: 714-734-6220

Colorado
Colorado Springs

Penrose Cancer Center at Penrose Hospital

Keren Sturtz
Ph: 888-785-6789

Rocky Mountain Cancer Centers at the Pavilion

Keren Sturtz
Ph: 888-785-6789

Wheat Ridge

Exempla Lutheran Medical Center

Keren Sturtz
Ph: 888-785-6789

Delaware
Newark

Helen F. Graham Cancer Center at Christiana Hospital

Stephen Scott Grubbs
Ph: 302-733-6227

Stephen Scott Grubbs
Ph: 302-733-6227

Medical Oncology Hematology Consultants, PA at Helen F. Graham Cancer Center

Stephen Scott Grubbs
Ph: 302-733-6227

Regional Hematology/Oncology, PA - Newark

Stephen Scott Grubbs
Ph: 302-733-6227

Florida
Daytona Beach

Florida Hospital Memorial Medical Center

Mudussara A Khan
Ph: 386-676-6025

Lakeland

Lakeland Regional Cancer Center at Lakeland Regional Medical Center

Madhavi L. Venigalla
Ph: 863-904-1900

Miami

University of Miami Sylvester Comprehensive Cancer Center - Miami

Deborah O Heros
Ph: 866-574-5124
Email: Sylvester@emergingmed.com

Pensacola

Sacred Heart Cancer Center at Sacred Heart Hospital

Thomas D. Sunnenberg
Ph: 850-416-4611

Sacred Heart Medical Oncology Group

Thomas D. Sunnenberg
Ph: 850-416-4611

Georgia
Atlanta

Piedmont Hospital

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

Gainesville

Northeast Georgia Medical Center

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

Hawaii
Aiea

Kapiolani Medical Center at Pali Momi

Jeffrey L. Berenberg
Ph: 808-586-2979

Jeffrey L. Berenberg
Ph: 808-586-2979

Ewa Beach

Leeward Radiation Oncology

Jeffrey L. Berenberg
Ph: 808-586-2979

Honolulu

Cancer Research Center of Hawaii

Jeffrey L. Berenberg
Ph: 808-586-2979

Hawaii Medical Center - East

Jeffrey L. Berenberg
Ph: 808-586-2979

OnCare Hawaii, Incorporated - Kuakini

Jeffrey L. Berenberg
Ph: 808-586-2979

Jeffrey L. Berenberg
Ph: 808-586-2979

OnCare Hawaii, Incorporated - Lusitana

Jeffrey L. Berenberg
Ph: 808-586-2979

Queen's Cancer Institute at Queen's Medical Center

Jeffrey L. Berenberg
Ph: 808-586-2979

Straub Clinic and Hospital, Incorporated

Jeffrey L. Berenberg
Ph: 808-586-2979

Idaho
Boise

Saint Alphonsus Cancer Care Center at Saint Alphonsus Regional Medical Center

Samir Narayan
Ph: 734-712-4673

Coeur D'Alene

Kootenai Medical Center

Benjamin Thomas Marchello
Ph: 800-648-6274

Post Falls

Kootenai Cancer Center - Post Falls

Benjamin Thomas Marchello
Ph: 800-648-6274

Illinois
Evanston

CCOP - Evanston

Ryan T Merrell
Ph: 847-570-2109

Glenview

Glenbrook Hospital

Ryan T Merrell
Ph: 847-570-2109

Highland Park

Highland Park Hospital

Ryan T Merrell
Ph: 847-570-2109

Peoria

Illinois CancerCare - Peoria

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

Urbana

Carle Cancer Center at Carle Foundation Hospital

Maria T Grosse-Perdekamp
Ph: 800-446-5532

Warrenville

Central Dupage Cancer Center

Sean A Grimm
Ph: 630-352-5300

Indiana
Elkhart

Michiana Hematology-Oncology, PC - Elkhart

Robin Zon
Ph: 574-234-5123

Mishawaka

Michiana Hematology-Oncology, PC - Mishawaka

Robin Zon
Ph: 574-234-5123

Saint Joseph's Medical Center

Robin Zon
Ph: 574-234-5123

Plymouth

Michiana Hematology Oncology PC - Plymouth

Robin Zon
Ph: 574-234-5123

South Bend

CCOP - Northern Indiana CR Consortium

Robin Zon
Ph: 574-234-5123

Memorial Hospital of South Bend

Thomas Joseph Reid
Ph: 800-284-7370

Michiana Hematology-Oncology, PC - South Bend

Robin Zon
Ph: 574-234-5123

Westville

Michiana Hematology Oncology-PC Westville

Robin Zon
Ph: 574-234-5123

Iowa
Ames

McFarland Clinic, PC

Joseph James Merchant
Ph: 515-239-2621

William R. Bliss Cancer Center at Mary Greeley Medical Center

Joseph James Merchant
Ph: 515-239-2621

Cedar Rapids

Cedar Rapids Oncology Associates

Deborah W Wilbur
Ph: 319-363-2690

Mercy Regional Cancer Center at Mercy Medical Center

Deborah W Wilbur
Ph: 319-363-2690

Mason City

Mercy Cancer Center at Mercy Medical Center - North Iowa

Arvind Y Vemula
Ph: 800-433-3883

Kansas
Wichita

Cancer Center of Kansas, PA - Wichita

Shaker R. Dakhil
Ph: 316-262-4467

Kentucky
Lexington

Central Baptist Hospital

Firas B Badin
Ph: 859-260-6425

University of Kentucky Chandler Medical Center

John L Villano
Ph: 859-257-3379

Maine
Lewiston

Central Maine Comprehensive Cancer Center at Central Maine Medical Center

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

Maryland
Rockville

Unidentified Site

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

Massachusetts
Boston

Boston University Cancer Research Center

Ken S. Zaner
Ph: 617-638-8265

Tufts Medical Center Cancer Center

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

Michigan
Ann Arbor

Saint Joseph Mercy Cancer Center

Samir Narayan
Ph: 734-712-4673

Battle Creek

Battle Creek Health System Cancer Care Center

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

Grand Rapids

Butterworth Hospital at Spectrum Health

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

Lacks Cancer Center at Saint Mary's Health Care

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

Kalamazoo

West Michigan Cancer Center

Raymond Sterling Lord
Ph: 269-373-7458

Saginaw

Seton Cancer Institute at Saint Mary's - Saginaw

Samir Narayan
Ph: 734-712-4673

Saint Joseph

Lakeside Cancer Specialists, PLLC

Robin Zon
Ph: 574-234-5123

Southfield

Providence Hospital - Southfield

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

St. Joseph

Lakeland Regional Cancer Care Center - St. Joseph

Robin Zon
Ph: 574-234-5123

Warren

St. John Macomb Hospital

Samir Narayan
Ph: 734-712-4673

Minnesota
Duluth

CCOP - Duluth

Bret E Friday
Ph: 888-203-7267

Rochester

Mayo Clinic Cancer Center

Alyx B Umphrey
Ph: 507-538-7623

Missouri
Bolivar

Central Care Cancer Center at Carrie J. Babb Cancer Center

Jay W Carlson
Ph: 800-821-7532

Chesterfield

Saint Luke's Hospital

Donald F. Busiek
Ph: 314-205-6936

Joplin

Freeman Cancer Institute at Freeman Health System

Jay W Carlson
Ph: 800-821-7532

Saint Louis

Siteman Cancer Center at Barnes-Jewish Hospital - Saint Louis

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

Springfield

St. John's Regional Health Center

Jay W Carlson
Ph: 800-821-7532

Montana
Billings

Billings Clinic Cancer Center - 801 N 29th Street

Benjamin Thomas Marchello
Ph: 800-648-6274

CCOP - Montana Cancer Consortium

Benjamin Thomas Marchello
Ph: 800-648-6274

Nebraska
Lincoln

Cancer Resource Center - Lincoln

Gamini S. Soori
Ph: 402-280-4100

Nevada
Las Vegas

CCOP - Nevada Cancer Research Foundation

John Allan Ellerton
Ph: 702-384-0013

New Hampshire
Concord

New Hampshire Oncology - Hematology, PA at Payson Center for Cancer Care

Douglas Jay Weckstein
Ph: 603-224-2556

Hooksett

New Hampshire Oncology - Hematology, PA - Hooksett

Douglas Jay Weckstein
Ph: 603-224-2556

Laconia

Lakes Region General Hospital

Douglas Jay Weckstein
Ph: 603-224-2556

Lebanon

Norris Cotton Cancer Center at Dartmouth-Hitchcock Medical Center

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

New Jersey
Somerville

Somerset Medical Center

James M Chimenti
Ph: 908-685-2481

New York
East Syracuse

CCOP - Hematology-Oncology Associates of Central New York

Jeffrey J. Kirshner
Ph: 315-472-7504

New York

Memorial Sloan-Kettering Cancer Center

Eli L Diamond
Ph: 212-639-7202

Rochester

Daisy Marquis Jones Radiation Oncology Center at Highland Hospital of Rochester

Yuhchyau Chen
Ph: 585-275-5830

James P. Wilmot Cancer Center at University of Rochester Medical Center

Yuhchyau Chen
Ph: 585-275-5830

University Radiation Oncology at Parkridge Hospital

Yuhchyau Chen
Ph: 585-275-5830

North Carolina
Goldsboro

Wayne Memorial Hospital, Incorporated

James N. Atkins
Ph: 919-580-0000

Kinston

Kinston Medical Specialists

Peter R. Watson
Ph: 252-559-2200

North Dakota
Grand Forks

Altru Cancer Center at Altru Hospital

Grant R Seeger
Ph: 701-780-6520

Ohio
Akron

McDowell Cancer Center at Akron General Medical Center

Esther H. Rehmus
Ph: 330-344-6348

Columbus

Riverside Methodist Hospital Cancer Care

J. Philip Kuebler
Ph: 614-566-3275

Toledo

Toledo Clinic, Incorporated - Main Clinic

Rex B Mowat
Ph: 800-444-3561

Oklahoma
Oklahoma City

Stephenson Cancer Center at the University of Oklahoma

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

Tulsa

LaFortune Cancer Center at St. John Medical Center

Coty Ho
Ph: 918-744-2685

Oregon
Gresham

Legacy Mount Hood Medical Center

Regan M Look
Ph: 503-280-1223

Portland

Legacy Good Samaritan Hospital & Comprehensive Cancer Center

Regan M Look
Ph: 503-280-1223

Tualatin

Legacy Meridian Park Hospital

Regan M Look
Ph: 503-280-1223

Pennsylvania
Allentown

Morgan Cancer Center at Lehigh Valley Hospital - Cedar Crest

Suresh G. Nair
Ph: 610-402-2273

Danville

Geisinger Cancer Institute at Geisinger Health

Scott G Turner
Ph: 570-271-5251

Gettysburg

Adams Cancer Center

Amir Tabatabai
Ph: 877-441-7957

Hanover

Cherry Tree Cancer Center

Amir Tabatabai
Ph: 877-441-7957

Wilkes-Barre

Frank M. and Dorothea Henry Cancer Center at Geisinger Wyoming Valley Medical Center

Scott G Turner
Ph: 570-271-5251

York

WellSpan Health

Amir Tabatabai
Ph: 877-441-7957

South Carolina
Easley

Cancer Centers of the Carolinas - Easley

David L Grisell
Ph: 864-241-6251

Greenville

Cancer Centers of the Carolinas - Andrews

David L Grisell
Ph: 864-241-6251

Cancer Centers of the Carolinas - Faris Road

David L Grisell
Ph: 864-241-6251

Cancer Centers of the Carolinas - Grove Commons

David L Grisell
Ph: 864-241-6251

CCOP - Greenville

David L Grisell
Ph: 864-241-6251

Greer

Cancer Centers of the Carolinas - Greer Radiation Oncology

David L Grisell
Ph: 864-241-6251

Seneca

Cancer Centers of the Carolinas - Seneca

David L Grisell
Ph: 864-241-6251

Spartanburg

Cancer Centers of the Carolinas - Spartanburg

David L Grisell
Ph: 864-241-6251

Gibbs Regional Cancer Center at Spartanburg Regional Medical Center

James Dewitt Bearden
Ph: 800-486-5941

South Dakota
Aberdeen

Conklin Regional Cancer Center

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

Sioux Falls

Avera Cancer Institute

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

Texas
San Antonio

University of Texas Health Science Center at San Antonio

Andrew J Brenner
Ph: 210-450-3800

Utah
Salt Lake City

Huntsman Cancer Institute at University of Utah

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

Washington
Puyallup

Good Samaritan Cancer Center

John A Keech
Ph: 907-458-5380

Tacoma

MultiCare Regional Cancer Center at Tacoma General Hospital

John A Keech
Ph: 907-458-5380

Vancouver

Legacy Salmon Creek Medical Center

Regan M Look
Ph: 503-280-1223

West Virginia
Morgantown

Mary Babb Randolph Cancer Center at West Virginia University Hospitals

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

Wisconsin
Green Bay

Green Bay Oncology, Limited at St. Mary's Hospital

Anthony J. Jaslowski
Ph: 800-432-6049

Green Bay Oncology, Limited at St. Vincent Hospital Regional Cancer Center

Anthony J. Jaslowski
Ph: 800-432-6049

St. Vincent Hospital Regional Cancer Center

Anthony J. Jaslowski
Ph: 800-432-6049

La Crosse

Gundersen Lutheran Center for Cancer and Blood

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

Manitowoc

Holy Family Memorial Medical Center Cancer Care Center

Anthony J. Jaslowski
Ph: 800-432-6049

Marshfield

Marshfield Clinic - Marshfield Center

Benjamin E. Lawler
Ph: 715-389-4457

Milwaukee

Froedtert Hospital and Medical College of Wisconsin

Jennifer M Connelly
Ph: 414-805-4380

Link to the current ClinicalTrials.gov record.
NLM Identifier NCT01781468
ClinicalTrials.gov processed this data on May 21, 2015

Note: Information about this trial is from the ClinicalTrials.gov database. The versions designated for health professionals and patients contain the same text. Minor changes may be made to the ClinicalTrials.gov record to standardize the names of study sponsors, sites, and contacts. Cancer.gov only lists sites that are recruiting patients for active trials, whereas ClinicalTrials.gov lists all sites for all trials. Questions and comments regarding the presented information should be directed to ClinicalTrials.gov.