Summary

for people ages 18 years and up (full criteria)
at La Jolla, California and other locations
study started

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.

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

Details

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.

Keywords

Fatigue Armodafinil Modafinil armodafinil 150 mg armodafinil 250 mg

Eligibility

For people ages 18 years and up

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

Locations

  • UC San Diego Moores Cancer Center currently not accepting new patients, but might later
    La Jolla California 92093 United States
  • Saint Joseph Hospital - Orange in progress, not accepting new patients
    Orange California 92868 United States
  • UC Irvine Health/Chao Family Comprehensive Cancer Center currently not accepting new patients, but might later
    Orange California 92868 United States
  • Loma Linda University Medical Center accepting new patients
    Loma Linda California 92354 United States
  • Providence Saint Joseph Medical Center/Disney Family Cancer Center accepting new patients
    Burbank California 91505 United States
  • Cancer and Blood Specialists-Henderson accepting new patients
    Henderson Nevada 89052 United States
  • Comprehensive Cancer Centers of Nevada - Henderson accepting new patients
    Henderson Nevada 89052 United States
  • Las Vegas Cancer Center-Henderson accepting new patients
    Henderson Nevada 89052 United States
  • Nevada Cancer Specialists-Saint Rose accepting new patients
    Henderson Nevada 89052 United States
  • HealthCare Partners Medical Group Oncology/Hematology-San Martin accepting new patients
    Las Vegas Nevada 89113 United States
  • Las Vegas Cancer Center-Medical Center accepting new patients
    Las Vegas Nevada 89148-2405 United States
  • 21st Century Oncology-Fort Apache accepting new patients
    Las Vegas Nevada 89148 United States
  • Comprehensive Cancer Centers of Nevada accepting new patients
    Las Vegas Nevada 89148 United States
  • Nevada Cancer Specialists-Fort Apache accepting new patients
    Las Vegas Nevada 89148 United States
  • 21st Century Oncology-Henderson accepting new patients
    Henderson Nevada 89074 United States
  • Comprehensive Cancer Centers of Nevada-Southeast Henderson accepting new patients
    Henderson Nevada 89074 United States
  • Radiation Oncology Centers of Nevada Southeast accepting new patients
    Las Vegas Nevada 89119 United States
  • Comprehensive Cancer Centers of Nevada-Summerlin accepting new patients
    Las Vegas Nevada 89144 United States
  • 21st Century Oncology accepting new patients
    Las Vegas Nevada 89109 United States
  • HealthCare Partners Medical Group Oncology/Hematology-Maryland Parkway accepting new patients
    Las Vegas Nevada 89109 United States
  • Comprehensive Cancer Centers of Nevada - Central Valley accepting new patients
    Las Vegas Nevada 89169 United States
  • Cancer Therapy and Integrative Medicine accepting new patients
    Las Vegas Nevada 89121 United States
  • 21st Century Oncology-Vegas Tenaya accepting new patients
    Las Vegas Nevada 89128 United States
  • Ann M Wierman MD LTD accepting new patients
    Las Vegas Nevada 89128 United States
  • Comprehensive Cancer Centers of Nevada - Northwest accepting new patients
    Las Vegas Nevada 89128 United States
  • HealthCare Partners Medical Group Oncology/Hematology-Tenaya accepting new patients
    Las Vegas Nevada 89128 United States
  • Cancer and Blood Specialists-Shadow accepting new patients
    Las Vegas Nevada 89106 United States
  • Nevada Cancer Research Foundation CCOP accepting new patients
    Las Vegas Nevada 89106 United States
  • Radiation Oncology Centers of Nevada Central accepting new patients
    Las Vegas Nevada 89106 United States

Details

Status
accepting new patients
Start Date
Sponsor
Alliance for Clinical Trials in Oncology
ID
NCT01781468
Phase
Phase 3
Study Type
Interventional
Last Updated
August 6, 2018