Trial record 1 of 1 for:    A221101
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Armodafinil in Reducing Cancer-Related Fatigue in Patients With High Grade Glioma

This study is currently recruiting participants. (see Contacts and Locations)
Verified April 2014 by Alliance for Clinical Trials in Oncology
Sponsor:
Collaborator:
Information provided by (Responsible Party):
Alliance for Clinical Trials in Oncology
ClinicalTrials.gov Identifier:
NCT01781468
First received: January 29, 2013
Last updated: April 11, 2014
Last verified: April 2014
  Purpose

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.


Condition Intervention Phase
Adult Giant Cell Glioblastoma
Adult Glioblastoma
Adult Gliosarcoma
Fatigue
Drug: armodafinil 150 mg
Other: Placebo
Drug: armodafinil 250 mg
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Supportive Care
Official Title: A Phase III Randomized, Double-Blind Placebo Controlled Study of Armodafinil (Nuvigil®) To Reduce Cancer-Related Fatigue in Patients With High Grade Glioma

Resource links provided by NLM:


Further study details as provided by Alliance for Clinical Trials in Oncology:

Primary Outcome Measures:
  • Response rate in terms of a clinically meaningful improvement in patient-reported fatigue at 8 weeks. A response is defined as an improvement of 2 points on the 0-10 scale of the usual fatigue on the Brief Fatigue Inventory (BFI). [ Time Frame: Up to 8 weeks ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Fatigue: Brief Fatigue Inventory (BFI), Patient Reported Outcomes - Common Terminology Criteria for Adverse Events (PRO-CTCAE) and the summated score from the Patient Reported Outcomes Measurement Information System (PROMIS) [ Time Frame: Up to 8 weeks ] [ Designated as safety issue: Yes ]
  • Cognitive function: As Assessed by Symbol Digit Modalities Test (SDMT), Controlled Oral Word Association, Trail Making Test, and the Functional Assessment of Cancer Therapy-Cognitive Function (FACT-Cog) [ Time Frame: Up to 8 weeks ] [ Designated as safety issue: No ]
  • Quality of Life as measured by Linear Analogue Self Assessment (LASA) [ Time Frame: Up to 8 weeks ] [ Designated as safety issue: No ]
  • Proportion of patients reporting adverse events via the CTCAE version 4.0 items [ Time Frame: Up to 8 weeks ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 330
Study Start Date: June 2013
Estimated Primary Completion Date: March 2016 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Arm I
Patients receive 150 mg armodafinil orally every day in the morning for 8 weeks.
Drug: armodafinil 150 mg
given orally
Placebo Comparator: Arm II
Patients receive placebo orally everyday in the morning for 8 weeks.
Other: Placebo
given orally
Experimental: Arm III
Patients receive 250 mg armodafinil orally everyday in the morning for 8 weeks.
Drug: armodafinil 250 mg
given orally

Detailed Description:

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

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01781468

  Hide Study Locations
Locations
United States, Arizona
Arizona Oncology-Deer Valley Center Recruiting
Phoenix, Arizona, United States, 85027
Contact: David Brachman, M.D.    602-240-3370      
Arizona Oncology Services Foundation Recruiting
Scottsdale, Arizona, United States, 85260
Contact: David Brachman, M.D.    602-240-3370      
Mayo Clinic in Arizona Recruiting
Scottsdale, Arizona, United States, 85259
Contact: Alyx Umphrey, M.D.    507-538-7623      
United States, California
UC San Diego Moores Cancer Center Recruiting
La Jolla, California, United States, 92093
Contact: Santosh Kesari, M.D.    858-822-7524      
UC Irvine Medical Center/Chao Family Comprehensive Cancer Center Recruiting
Orange, California, United States, 92868
Contact: Jose Carrillo, M.D.    714-456-5384      
United States, Colorado
Exempla Lutheran Medical Center Recruiting
Wheat Ridge, Colorado, United States, 80033
Contact: Keren Sturtz, M.D.    303-777-2663      
United States, Delaware
Christiana Care Health System-Christiana Hospital Recruiting
Newark, Delaware, United States, 19718
Contact: Stephen Grubbs, M.D.    302-366-1200      
United States, Florida
University of Miami Miller School of Medicine-Sylvester Cancer Center Recruiting
Miami, Florida, United States, 33136
Contact: Deborah Heros, M.D.    305-243-1691      
Florida Hospital Recruiting
Orlando, Florida, United States, 32803
Contact: Lee Zehngebot, M.D.    407-303-2800 ext 1104292      
Sacred Heart Hospital Recruiting
Pensacola, Florida, United States, 32504
Contact: Thomas Sunnenberg, M.D.    850-416-4611      
Sacred Heart Medical Oncology Group - Davis Highway Recruiting
Pensacola, Florida, United States, 32514
Contact: Thomas Sunnenberg, M.D.    850-416-4611      
United States, Georgia
Georgia Regents University Recruiting
Augusta, Georgia, United States, 30912
Contact: Daron Ferris, M.D.    706-721-2535      
Northeast Georgia Medical Center Recruiting
Gainesville, Georgia, United States, 30501
Contact: Kendal Dixon, M.D.    770-531-0093      
United States, Hawaii
Oncare Hawaii Inc-Pali Momi Recruiting
Aiea, Hawaii, United States, 96701
Contact: Jeffrey Berenberg, M.D.    808-433-4089      
Pali Momi Medical Center Recruiting
Aiea, Hawaii, United States, 96701
Contact: Jeffrey Berenberg, M.D.    808-433-4089      
The Cancer Center of Hawaii-Leeward Recruiting
Ewa Beach, Hawaii, United States, 96706
Contact: Jeffrey Berenberg, M.D.    808-433-4089      
Straub Clinic and Hospital Recruiting
Honolulu, Hawaii, United States, 96813
Contact: Jeffrey Berenberg, M.D.    808-433-4089      
Oncare Hawaii Inc-Kuakini Recruiting
Honolulu, Hawaii, United States, 96817
Contact: Jeffrey Berenberg, M.D.    808-433-4089      
University of Hawaii Recruiting
Honolulu, Hawaii, United States, 96813
Contact: Jeffrey Berenberg, M.D.    808-433-4089      
Oncare Hawaii Inc-POB II Recruiting
Honolulu, Hawaii, United States, 96813
Contact: Jeffrey Berenberg, M.D.    808-433-4089      
The Cancer Center of Hawaii-Liliha Recruiting
Honolulu, Hawaii, United States, 96817
Contact: Jeffrey Berenberg, M.D.    808-433-4089      
Queen's Medical Center Recruiting
Honolulu, Hawaii, United States, 96813
Contact: Jeffrey Berenberg, M.D.    808-433-4089      
OnCare Hawaii-Liliha Recruiting
Honolulu, Hawaii, United States, 96817
Contact: Jeffrey Berenberg, M.D.    808-433-4089      
United States, Idaho
Saint Alphonsus Regional Medical Center Recruiting
Boise, Idaho, United States, 83706
Contact: Samir Narayan, M.D.    734-712-3596      
United States, Illinois
NorthShore University HealthSystem-Evanston Hospital Recruiting
Evanston, Illinois, United States, 60201
Contact: Ryan Merrell, M.D.    847-570-2570      
NorthShore University HealthSystem-Glenbrook Hospital Recruiting
Glenview, Illinois, United States, 60026
Contact: Ryan Merrell, M.D.    847-570-2570      
NorthShore University HealthSystem-Highland Park Hospital Recruiting
Highland Park, Illinois, United States, 60035
Contact: Ryan Merrell, M.D.    847-570-2570      
Illinois CancerCare Recruiting
Peoria, Illinois, United States, 61615
Contact: Nguyet Le-Lindqwister, M.D.    309-243-3607      
Carle Cancer Center Recruiting
Urbana, Illinois, United States, 61801
Contact: Maria Perdekamp-Grosse, M.D.    217-383-3010      
United States, Indiana
Elkhart Clinic Recruiting
Elkhart, Indiana, United States, 46514
Contact: Robin Zon, M.D.    574-647-6343      
Michiana Hematology Oncology PC-Elkhart Recruiting
Elkhart, Indiana, United States, 46514
Contact: Robin Zon, M.D.    574-647-6343      
Elkhart General Hospital Recruiting
Elkhart, Indiana, United States, 46515
Contact: Robin Zon, M.D.    574-647-6343      
Community Howard Regional Health Recruiting
Kokomo, Indiana, United States, 46904
Contact: Robin Zon, M.D.    574-647-6343      
Indiana University Health La Porte Hospital Recruiting
La Porte, Indiana, United States, 46350
Contact: Robin Zon, M.D.    574-647-6343      
Saint Joseph Regional Medical Center-Mishawaka Recruiting
Mishawaka, Indiana, United States, 46545
Contact: Robin Zon, M.D.    574-647-6343      
Michiana Hematology Oncology PC-Mishawaka Recruiting
Mishawaka, Indiana, United States, 46545
Contact: Robin Zon, M.D.    574-647-6343      
Michiana Hematology Oncology PC-Mishawaka Recruiting
Mishawaka, Indiana, United States, 46545
Contact: Robin Zon, M.D.    574-234-5123      
Michiana Hematology Oncology PC-Plymouth Recruiting
Plymouth, Indiana, United States, 46563
Contact: Robin Zon, M.D.    574-647-6343      
Northern Indiana Cancer Research Consortium Recruiting
South Bend, Indiana, United States, 46628
Contact: Robin Zon, M.D.    574-647-6343      
Memorial Hospital of South Bend Recruiting
South Bend, Indiana, United States, 46601
Contact: Robin Zon, M.D.    574-647-6343      
Michiana Hematology Oncology PC-South Bend Recruiting
South Bend, Indiana, United States, 46601
Contact: Robin Zon, M.D.    574-647-6343      
Michiana Hematology Oncology-PC Westville Recruiting
Westville, Indiana, United States, 46391
Contact: Robin Zon, M.D.    574-647-6343      
United States, Iowa
McFarland Clinic PC - William R. Bliss Cancer Center Recruiting
Ames, Iowa, United States, 50010
Contact: Joseph Merchant, M.D.    515-956-2759      
United States, Kansas
Cancer Center of Kansas - Main Office Recruiting
Wichita, Kansas, United States, 67214
Contact: Shaker Dakhil, M.D.    316-262-4467      
United States, Kentucky
University of Kentucky Recruiting
Lexington, Kentucky, United States, 40536
Contact: John Villano, M.D.    859-323-8043      
Baptist Health Lexington Recruiting
Lexington, Kentucky, United States, 40503
Contact: Firas Badin, M.D.    859-260-6295      
United States, Maine
Central Maine Medical Center Recruiting
Lewiston, Maine, United States, 04240
Contact: David Caldwell, M.D.    207-795-2935      
United States, Massachusetts
Boston Medical Center Recruiting
Boston, Massachusetts, United States, 02118
Contact: Ken Zaner, M.D.    617-638-5631      
United States, Michigan
Saint Joseph Mercy Hospital Recruiting
Ann Arbor, Michigan, United States, 48106
Contact: Samir Narayan, M.D.    734-712-3596      
Saint Mary's of Michigan Recruiting
Saginaw, Michigan, United States, 48601
Contact: Samir Narayan, M.D.    734-712-3596      
Marie Yeager Cancer Center Recruiting
Saint Joseph, Michigan, United States, 49085
Contact: Robin Zon, M.D.    574-647-6343      
Lakeland Hospital Recruiting
Saint Joseph, Michigan, United States, 49085
Contact: Robin Zon, M.D.    574-647-6343      
Saint John Macomb-Oakland Hospital Recruiting
Warren, Michigan, United States, 48093
Contact: Samir Narayan, M.D.    734-712-3596      
United States, Minnesota
Essentia Health Duluth Clinic CCOP Recruiting
Duluth, Minnesota, United States, 55805
Contact: Bret Friday, M.D.    218-786-3625      
Mayo Clinic Recruiting
Rochester, Minnesota, United States, 55905
Contact: Alyx Umphrey, M.D.    507-538-7623      
United States, Missouri
Saint Luke's Hospital Recruiting
Chesterfield, Missouri, United States, 63017
Contact: Donald Busiek, M.D.    314-205-6737      
Freeman Health System Recruiting
Joplin, Missouri, United States, 64804
Contact: John Vu, M.D.    417-347-4000      
Mercy Hospital Saint Louis Recruiting
Saint Louis, Missouri, United States, 63141
Contact: Jay Carlson, M.D.    417-820-3554      
Washington University School of Medicine Recruiting
Saint Louis, Missouri, United States, 63110
Contact: David Tran, M.D.    314-747-7509      
Mercy Hospital - Springfield Recruiting
Springfield, Missouri, United States, 65804
Contact: Jay Carlson, M.D.    417-820-3554      
United States, Nevada
Nevada Cancer Research Foundation CCOP Recruiting
Las Vegas, Nevada, United States, 89106
Contact: John Ellerton, M.D.    702-383-7336      
United States, New Hampshire
New Hampshire Oncology-Hematology PA Recruiting
Concord, New Hampshire, United States, 03301
Contact: Jeanna Walsh, M.D.    603-622-6484      
New Hampshire Oncology Hematology Associates Recruiting
Hooksett, New Hampshire, United States, 03106
Contact: Jeanna Walsh, M.D.    603-622-6484      
LRGHealthcare-Lakes Region General Hospital Recruiting
Laconia, New Hampshire, United States, 03246
Contact: Jeanna Walsh, M.D.    603-622-6484      
United States, New York
Hematology Oncology Associates of Central New York PC Recruiting
East Syracuse, New York, United States, 13057
Contact: Jeffrey Kirshner, M.D.    315-472-7504      
United States, North Carolina
Wayne Memorial Hospital Recruiting
Goldsboro, North Carolina, United States, 27534
Contact: James Atkins, M.D.    919-580-0000      
Kinston Medical Specialists PA Recruiting
Kinston, North Carolina, United States, 28501
Contact: Peter Watson, M.D.    252-559-2201      
United States, Ohio
Toledo Clinic Cancer Centers - Toledo Recruiting
Toledo, Ohio, United States, 43623
Contact: Rex Mowat, M.D.    517-263-2507      
United States, Oregon
Legacy Mount Hood Medical Center Recruiting
Gresham, Oregon, United States, 97030
Contact: Regan Look, M.D.    503-413-7202      
Legacy Good Samaritan Hospital and Medical Center Recruiting
Portland, Oregon, United States, 97210
Contact: Regan Look, M.D.    503-413-7202      
Legacy Meridian Park Hospital Recruiting
Tualatin, Oregon, United States, 97062
Contact: Regan Look, M.D.    503-413-7202      
United States, Pennsylvania
Geisinger Medical Center Recruiting
Danville, Pennsylvania, United States, 17822
Contact: Scott Turner, M.D.    319-363-2690      
Adams Cancer Center Recruiting
Gettysburg, Pennsylvania, United States, 17325
Contact: Amir Tabatabai, M.D.    717-741-8124      
Cherry Tree Cancer Center Recruiting
Hanover, Pennsylvania, United States, 17331
Contact: Amir Tabatabai, M.D.    717-741-8124      
Geisinger Wyoming Valley/Henry Cancer Center Recruiting
Wilkes-Barre, Pennsylvania, United States, 18711
Contact: Scott Turner, M.D.    319-363-2690      
WellSpan Health-York Hospital Recruiting
York, Pennsylvania, United States, 17405
Contact: Amir Tabatabai, M.D.    717-741-9229      
United States, South Carolina
AnMed Health Cancer Center Recruiting
Anderson, South Carolina, United States, 29621
Contact: James Bearden, M.D.    864-560-6812      
Spartanburg Regional Medical Center Recruiting
Spartanburg, South Carolina, United States, 29303
Contact: James Bearden, M.D.    864-560-6812      
United States, South Dakota
Avera Saint Luke's Hospital and Cancer Center Recruiting
Aberdeen, South Dakota, United States, 57401
Contact: Richard Conklin, M.D.    605-622-5613      
United States, Utah
Huntsman Cancer Institute - University of Utah Recruiting
Salt Lake City, Utah, United States, 84112
Contact: Howard Colman, M.D.    801-585-0270      
United States, Washington
Good Samaritan Community Hospital Recruiting
Puyallup, Washington, United States, 98372
Contact: John Keech, M.D.    253-530-8060      
Northwest CCOP Recruiting
Tacoma, Washington, United States, 98405
Contact: John Keech, M.D.    253-530-8060      
Multicare Health System - Tacoma General Hospital Recruiting
Tacoma, Washington, United States, 98415
Contact: John Keech, M.D.    253-530-8060      
Multicare Health System Recruiting
Tacoma, Washington, United States, 98415
Contact: John Keech, M.D.    253-530-8060      
Legacy Salmon Creek Hospital Recruiting
Vancouver, Washington, United States, 98686
Contact: Regan Look, M.D.    503-413-7202      
United States, Wisconsin
Green Bay Oncology at Saint Vincent Hospital Recruiting
Green Bay, Wisconsin, United States, 54301-3526
Contact: Anthony J. Jaslowski, M.D.    610-402-2273      
Green Bay Oncology Limited at Saint Mary's Hospital Recruiting
Green Bay, Wisconsin, United States, 54303
Contact: Anthony J. Jaslowski, M.D.    610-402-2273      
St. Vincent Hospital Recruiting
Green Bay, Wisconsin, United States, 54301
Contact: Anthony J. Jaslowski, MD    920-884-3135      
Gundersen Lutheran Health System/CCOP Recruiting
La Crosse, Wisconsin, United States, 54601
Contact: Michael Ojelabi, M.D.    608-782-7300      
Holy Family Memorial Hospital Recruiting
Manitowoc, Wisconsin, United States, 54221
Contact: Anthony J. Jaslowski, M.D.    610-402-2273      
Marshfield Clinic Recruiting
Marshfield, Wisconsin, United States, 54449
Contact: Benjamin Lawler, M.D.    715-389-3133      
Froedtert and the Medical College of Wisconsin Recruiting
Milwaukee, Wisconsin, United States, 53226
Contact: Jennifer Connelly, M.D.    414-805-5207      
Sponsors and Collaborators
Alliance for Clinical Trials in Oncology
Investigators
Study Chair: Alyx B. Porter Umphrey, M.D. Mayo Clinic
  More Information

No publications provided

Responsible Party: Alliance for Clinical Trials in Oncology
ClinicalTrials.gov Identifier: NCT01781468     History of Changes
Other Study ID Numbers: A221101, N10C3, NCI-2012-02020, U10CA031946
Study First Received: January 29, 2013
Last Updated: April 11, 2014
Health Authority: United States: Food and Drug Administration
United States: Institutional Review Board

Additional relevant MeSH terms:
Glioblastoma
Fatigue
Gliosarcoma
Astrocytoma
Glioma
Neoplasms, Neuroepithelial
Neuroectodermal Tumors
Neoplasms, Germ Cell and Embryonal
Neoplasms by Histologic Type
Neoplasms
Neoplasms, Glandular and Epithelial
Neoplasms, Nerve Tissue
Signs and Symptoms
Armodafinil
Modafinil
Wakefulness-Promoting Agents
Central Nervous System Stimulants
Central Nervous System Agents
Therapeutic Uses
Pharmacologic Actions
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on October 16, 2014