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



Status:Recruiting
Conditions:Other Indications, Brain Cancer
Therapuetic Areas:Oncology, Other
Healthy:No
Age Range:18 - Any
Updated:9/8/2018
Start Date:June 2013
Contact:Alyx B. Porter Umphrey, MD
Phone:(507) 266-5230

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A Phase III Randomized, Double-Blind Placebo Controlled Study of Armodafinil (Nuvigil®) To Reduce Cancer-Related Fatigue in Patients With High Grade Glioma

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.

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.

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
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