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A Phase III Randomized, Double-Blind Placebo Controlled Study of Armodafinil (NuvigilĀ®) To Reduce Cancer-Related Fatigue in Patients With High Grade Glioma ALLIANCE A0221101
Overall Recruitment Status: Active, currently enrolling
 
Official Title
A Phase III Randomized, Double-Blind Placebo Controlled Study of Armodafinil (NuvigilĀ®) To Reduce Cancer-Related Fatigue in Patients With High Grade Glioma ALLIANCE A0221101
 
Region Sponsors
Mid-Atlantic
Alliance for Clinical Trials in Oncology
 
Acronym KP IRB No.
A0221101 MA-16-121
 
Study Type Phase
Clinical Trial Phase III
 
Study Population Description
Patients wih High-Grade Gliomas being treated for their cancer and reporting fatigue.
 
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 patients experiencing fatigue related to cancer. Cancer-related fatigue is a very common symptom in patients with cancer. Patients will receive armodafinil or placebo.
 
Detailed Description
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.
 
Gender Age Limit
Male & Female 18 years & older
 
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 > 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). 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 per the second eligibility criteria, but chemotherapy is allowed.
  • Negative serum pregnancy test done =/< 7 days prior to registration only for women determined to be of childbearing potential by the treating physician.
  • 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
 
Exclusion Criteria
  • Pregnant women, nursing women, men or women of childbearing potential who are unwilling to employ adequate contraception since this study involves an investigational agent whose genotoxic, mutagenic and teratogenic effects on the developing fetus and newborn are unknown.
  • 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 prior to registration and plans to continue for the duration of the trial. Erythropoietin agents to treat anemia are allowed. Exercise is allowed.

 
Keywords and/or Specific Medical Conditions
  • (BFI) Brief Fatigue Inventory
  • High-Grade Glioma
  • (LASA) Linear Analouge Self Assessment
  • Oncology (Adult)
  • Cancer Treatment Related-Fatigue
  • Preventative Medicine
  • Glioma
 
KP Clinical Facility
  • Burke Medical Center
  • Capitol Hill Medical Center
  • Gaithersburg Medical Center
  • Largo Medical Center
  • Tyson's Corner Medical Center
  • Woodlawn Medical Center
 
Clinical Area
  • Oncology (Adult)
  • Preventative Medicine


Principal Investigator:
Leon c Hwang, MD
Contact Information:
- Diane Fisher, RN
-301-386-6692
-Diane.Fisher@kp.org
-Largo Medical Center


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