A Randomized Placebo-Controlled Trial of Armodafinil (Nuvigil) for Fatigue in Patients With Malignant Gliomas
Status: Recruiting
Phase: Phase 2
Diagnosis: Brain/Neuro Cancer: Supportative Care
NCT ID: NCT00766467
(View complete trial on ClinicalTrials.gov)
DFCI Protocol ID: 07-341
The purpose of this research study is to determine if armodafinil is safe and effective in treating fatigue in patients with malignant gliomas undergoing treatment with radiotherapy plus temodar. Armodafinil is a wakefulness-promoting agent that has been FDA approved for the treatment of excessive daytime sleepiness for a variety of disorders. Armodafinil may also help to reduce radiation-induced fatigue in brain tumor patients.
Conducting Institutions:
Dana-Farber Cancer Institute, Beth-Israel Deaconess Medical Center, Brigham and Women's Hospital
Overall PI:
Eric Wong, MD,
Beth Israel Deaconess Medical Center
Site-responsible Investigators:
Jan Drappatz, MD,
Dana-Farber Cancer Institute
Contacts:
Dana-Farber Cancer Institute:
Samantha Hammond, 617-632-5396,
samantha_hammond@dfci.harvard.edu
Beth-Israel Deaconess Medical Center:
Cancer Trials Call Center, 617-667-3060
Eligibility Criteria
Inclusion Criteria:
- 18 years of age or older
- Histologically confirmed malignant glioma including anaplastic astrocytoma, anaplastic
oligodendroglioma, anaplastic oligoastrocytoma (WHO grade III/IV), glioblastoma
multiforme (WHO grade IV) or gliosarcoma. Patients with a grade II astrocytoma, mixed
oligo-astrocytoma or oligodendroglioma who are being treated with irradiation are also
eligible
- Scheduled to receive irradiation to a total dose of 50-60 Gy. Patients receiving
hyperfractionated radiotherapy are also eligible
- KPS of 70% or greater
- Electrolytes within normal institutional limits: BUN and Creatinine < 2.5 x ULN: AST,
ALT, Bilirubin < 2.5 x ULN
- Life expectancy of six months or greater
- Able to swallow medication
Exclusion Criteria:
- History of cardiac arrhythmia or unstable angina
- Has taken armodafinil or modafinil
- Has taken a psychostimulant or a monoamine oxidase inhibitor on a regular basis within
the past 30 days
- A history of clinically significant cardiac disease, including a history of recent
myocardial infarction, history of unstable angina, history of left ventricular
hypertrophy, or a history of ischemic ECG changes, chest pain, arrhythmia, or other
clinically significant manifestations of mitral valve prolapse in association with use
of CNS stimulants, uncontrolled hypertension, alcohol or drug abuse, severe headaches,
glaucoma, narcolepsy, a psychotic disorder or Tourette's syndrome
- Patients taking warfarin for anticoagulation are eligible, but monitoring of
prothrombin times is suggested as a precaution
- Hemoglobin level of less then 12 g/dl
- Laboratory evidence of hypothyroidism with an elevated TSH concentration in the blood
greater than 5.0 mlU/L
- Current treatment or history of psychotic disorder, bipolar disorder, or anxiety
disorder
- Patients with a score of > 31 on the Beck depression inventory consistent with severe
depression
- Known hypersensitivity to armodafinil or related compounds
- Patients who have been receiving MAO inhibitors during the past 14 days