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Clinical Trials (PDQ®)

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

Basic Trial Information
Trial Description
     Summary
     Further Trial Information
     Eligibility Criteria
Trial Contact Information

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 multiforme, anaplastic astrocytoma, gliosarcoma, or anaplastic oligodendroglioma 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 anaplastic astrocytoma, or anaplastic oligodendroglioma 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, for women of childbearing potential only, per physician discretion
  • 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)
* Note: during the Active Monitoring Phase of a study (i.e., active treatment and observation), participants must be willing to return to the consenting institution for follow-up
  • Stable dose of corticosteroid ≤ 28 days prior to registration

Exclusion Criteria:

  • Any of the following because this study involves an agent whose genotoxic, mutagenic and teratogenic effects on the developing fetus and newborn are unknown in pregnant women, nursing women, men or women of childbearing potential who are unwilling to employ adequate contraception
  • 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, and clinical depression per physician discretion
  • Active or a history of Tourette 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:

1. Inducers of CYP3A4

1. Efavirenz (Sustiva®)

2. Nevirapine (Viramune®)

3. Carbamazepine (Carbatrol®, Epitol®, Equetro™)

4. Tegretol®, Tegretol-XR®)

5. Modafinil (Provigil®)

6. Phenobarbital (Luminal®)

7. Phenytoin (Dilantin®, Phenytek®)

8. Pioglitazone (Actos®)

9. Rifabutin (Mycobutin®)

10. Rifampin (Rifadin®)

11. 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
  Phoenix
 Arizona Oncology - Deer Valley Center
 David G. Brachman Ph: 800-360-6371
  Scottsdale
 Arizona Oncology Services Foundation
 David G. Brachman Ph: 800-360-6371
 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
  Orange
 Chao Family Comprehensive Cancer Center at University of California Irvine Medical Center
 Jose A Carrillo Ph: 877-827-8839
  Email: ucstudy@uci.edu
Delaware
  Newark
 Helen F. Graham Cancer Center at Christiana Hospital
 Stephen Scott Grubbs Ph: 302-733-6227
Florida
  Orlando
 Florida Hospital Cancer Institute at Florida Hospital Orlando
 Lee M. Zehngebot Ph: 407-303-5623
  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
  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
Illinois
  Evanston
 CCOP - Evanston
 Ryan T Merrell Ph: 847-570-2109
  Peoria
 Illinois CancerCare - Peoria
 Nguyet A Le-Lindqwister Ph: 800-793-2262
Indiana
  Elkhart
 Elkhart Clinic, LLC
 Robin Zon Ph: 574-234-5123
 Elkhart General Hospital
 Robin Zon Ph: 574-234-5123
 Michiana Hematology-Oncology, PC - Elkhart
 Robin Zon Ph: 574-234-5123
  Kokomo
 Community Cancer Care at Howard Regional Health System
 Robin Zon Ph: 574-234-5123
  La Porte
 Center for Cancer Therapy at LaPorte Hospital and Health Services
 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
 Deborah W Wilbur Ph: 319-363-2690
 Mercy Regional Cancer Center at Mercy Medical Center
 Deborah W Wilbur Ph: 319-363-2690
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
Massachusetts
  Boston
 Boston University Cancer Research Center
 Ken S. Zaner Ph: 617-638-8265
Michigan
  Battle Creek
 Battle Creek Health System Cancer Care Center
 Gilbert D Padula Ph: 616-685-5225
  Grand Rapids
 Butterworth Hospital at Spectrum Health
 Gilbert D Padula Ph: 616-685-5225
 CCOP - Grand Rapids
 Gilbert D Padula Ph: 616-685-5225
 Lacks Cancer Center at Saint Mary's Health Care
 Gilbert D Padula Ph: 616-685-5225
  Kalamazoo
 West Michigan Cancer Center
 Raymond Sterling Lord Ph: 269-373-7458
  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
Minnesota
  Rochester
 Mayo Clinic Cancer Center
 Alyx B Umphrey Ph: 507-538-7623
Missouri
  Chesterfield
 Saint Luke's Hospital
 Donald F. Busiek Ph: 314-205-6936
  Saint Louis
 Siteman Cancer Center at Barnes-Jewish Hospital - Saint Louis
 David D Tran Ph: 800-600-3606
  Email: info@siteman.wustl.edu
  Springfield
 St. John's Regional Health Center
 Jay W Carlson Ph: 800-821-7532
  Email: sherrijr@iora.org
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
 Jeanna H Walsh Ph: 800-339-6484
  Hooksett
 New Hampshire Oncology - Hematology, PA - Hooksett
 Jeanna H Walsh Ph: 800-339-6484
  Laconia
 Lakes Region General Hospital
 Jeanna H Walsh Ph: 800-339-6484
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
North Carolina
  Goldsboro
 Wayne Memorial Hospital, Incorporated
 James N. Atkins Ph: 919-580-0000
  Hendersonville
 Park Ridge Hospital Breast Health Center
 James Dewitt Bearden Ph: 800-486-5941
  Kinston
 Kinston Medical Specialists
 Peter R. Watson Ph: 252-559-2200
Oklahoma
  Oklahoma City
 Oklahoma University Cancer Institute
 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
  Anderson
 AnMed Cancer Center
 James Dewitt Bearden Ph: 800-486-5941
  Spartanburg
 Gibbs Regional Cancer Center at Spartanburg Regional Medical Center
 James Dewitt Bearden Ph: 800-486-5941
South Dakota
  Aberdeen
 Conklin Regional Cancer Center
 Richard J. Conklin Ph: 605-622-5613
  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: 210-616-5798
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
 Yoshio Inoue Ph: 253-403-2394
  Tacoma
 CCOP - Northwest
 Yoshio Inoue Ph: 253-403-2394
 MultiCare Regional Cancer Center at Tacoma General Hospital
 Yoshio Inoue Ph: 253-403-2394
  Vancouver
 Legacy Salmon Creek Medical Center
 Regan M Look Ph: 503-280-1223
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
  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 Identifer NCT01781468
ClinicalTrials.gov processed this data on April 13, 2014

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.

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