Overview

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

Status:
Completed
Trial end date:
2019-12-15
Target enrollment:
0
Participant gender:
All
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.
Phase:
Phase 3
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
Alliance for Clinical Trials in Oncology
Collaborator:
National Cancer Institute (NCI)
Treatments:
Armodafinil
Modafinil
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