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

Eligibility

Eligible Ages
Over 18 Years
Eligible Genders
All
Accepts Healthy Volunteers
No

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 (excluding stereotactic radiosurgery) > 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); it is not required for the patient to complete the entire BFI to meet this
criterion

- 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; patients who are currently using Optune device will be
eligible to participate in this trial

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

Study Design

Phase
Phase 3
Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel Assignment
Primary Purpose
Supportive Care
Masking
Double (Participant, Investigator)

Arm Groups

ArmDescriptionAssigned Intervention
Experimental
Arm I
Patients receive 150 mg armodafinil orally every day in the morning for 8 weeks.
  • Drug: armodafinil 150 mg
    given orally
  • Other: Placebo
    given orally
  • Drug: armodafinil 250 mg
    given orally
Placebo Comparator
Arm II
Patients receive placebo orally every day in the morning for 8 weeks.
  • Other: Placebo
    given orally
  • Drug: armodafinil 250 mg
    given orally
Experimental
Arm III
Patients receive 250 mg armodafinil orally every day in the morning for 8 weeks.
  • Drug: armodafinil 250 mg
    given orally

Recruiting Locations

University of Texas Health Science Center at San Antonio
San Antonio, Texas 78229
Contact:
Site Public Contact
210-450-3800
phoresearchoffice@uthscsa.edu

More Details

NCT ID
NCT01781468
Status
Recruiting
Sponsor
Alliance for Clinical Trials in Oncology

Study Contact

Alyx B. Porter Umphrey, MD
(507) 266-5230

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 high grade glioma.

3. To assess the impact of armodafinil on global quality of life and other fatigue endpoints 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.

Notice

Study information shown on this site is derived from ClinicalTrials.gov (a public registry operated by the National Institutes of Health). The listing of studies provided is not certain to be all studies for which you might be eligible. Furthermore, study eligibility requirements can be difficult to understand and may change over time, so it is wise to speak with your medical care provider and individual research study teams when making decisions related to participation.