Armodafinil in Treating Fatigue Caused By Radiation Therapy in Patients With Primary Brain Tumors

• Status: Completed
• Trial end date: 2013-01-08
• Target enrollment: 0
• Participant gender: All

Summary

RATIONALE: Armodafinil may help relieve fatigue and improve quality of life in patients with cancer receiving radiation therapy to the brain.

PURPOSE: This clinical trial is studying how well armodafinil works in treating fatigue caused by radiation therapy in patients with primary brain tumors.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Wake Forest Cancer Center CCOP Research Base; Wake Forest University Health Sciences
• Collaborator: National Cancer Institute (NCI)
• Treatments: Armodafinil; Modafinil

Criteria

Inclusion Criteria

• Histologically confirmed primary brain tumor, including any of the following:

• Glioblastoma multiforme

• Anaplastic astrocytoma

• Anaplastic oligodendroglioma

• Anaplastic mixed oligoastrocytoma

• Low-grade glioma

• Meningioma

• Ependymoma

• Other primary brain tumor histologies

• Planning to undergo external-beam cranial radiotherapy (partial- or whole-brain radiotherapy) meeting all of the following criteria:

• Total dose ≥ 4,500 cGy

• Total number of fractions ≥ 25 fractions

• Dose per fraction ≥ 150 cGy

PATIENT CHARACTERISTICS:

• Karnofsky performance status 60-100%

• Hemoglobin ≥ 10.0 g/dL (erythropoietin or transfusion allowed for symptomatically anemic patients with a hemoglobin < 10 g/dL)

• Creatinine ≤ 2 mg/dL

• Total bilirubin ≤ 2 times upper limit of normal (ULN)

• SGOT and SGPT ≤ 3 times ULN

• Not pregnant or nursing

• Negative pregnancy test

• Sexually active women of childbearing potential must use a reliable method of birth control

• It is recommended that patients use non-hormonal contraceptives, in addition to or in place of hormonal contraceptives, during and for one month following treatment with armodafinil

• Prior malignancies allowed

Exclusion Criteria:

• No baseline headaches (i.e., headaches occurring in the week before baseline assessment) of grade 4 severity (defined as severe and disabling headaches, requiring analgesics, and interfering with and preventing function or activities of daily living)

• No concurrent uncontrolled illness that may cause fatigue; interfere with drug absorption, distribution, metabolism, or excretion; or limit compliance with study requirements including, but not limited to, any of the following:

• Ongoing or active infection

• Chronic renal insufficiency

• Psychiatric illness (psychosis, psychotic disorder, history of suicide attempt, or actively suicidal)

• Extreme social situations (e.g., transportation issues that would preclude study compliance)

• Patients with a history of cardiac issues (symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia) should not use armodafinil as it may cause chest pain, palpitations, dyspnea, and transient ischemic T-wave changes on ECG

• No history of allergic reaction attributed to modafinil or armodafinil

• No anticipated or planned excessive consumption of coffee, tea, and/or caffeine-containing beverages averaging > 600 mg of caffeine/day (i.e., approximately 6 cups of coffee/day, 12 cups of hot tea/day, or 12 cans of cola/day)

PRIOR CONCURRENT THERAPY:

• See Disease Characteristics

• No prior fractionated external-beam cranial radiotherapy

• More than 30 days since prior monoamine oxidate inhibitors or investigational drugs

• More than 2 weeks since prior and no concurrent modafinil (Provigil), donepezil (Aricept), memantine hydrochloride (Namenda), methylphenidate (Ritalin), dextroamphetamine-amphetamine (Adderall), ginkgo biloba, or any other cognitive function-enhancing drugs

• At least 4 weeks since prior and no concurrent interstitial or intracavitary chemotherapy and/or radiotherapy or stereotactic radiosurgery (i.e., Gamma Knife, Linac, or Cyberknife)

• No concurrent erythropoietin, transfusion, or iron therapy (unless patient is symptomatically anemic with hemoglobin < 10 g/dL)

• Concurrent chemotherapy allowed

• Concurrent hormonal therapy for other malignancies allowed

• No concurrent non-hormonal therapy (e.g., Herceptin and other targeted agents), or cytotoxic chemotherapy

• No concurrent clopidogrel bisulfate (Plavix)