• Neurocognitive functioning as assessed by Trail Making Test, Symbol Digit Modalities Test, and Verbal Fluency at baseline and weeks 1, 3, 4, 8, and 10
  
• Mood as assessed by Hamilton Depression Scale (31 questions) at baseline and weeks 3, 4, 8, and 10
  
• Fatigue level as assessed by Fatigue Severity Scale, Modified Fatigue Impact Scale, and Visual Analogue Fatigue Scale at baseline and weeks 1, 3, 4, 5, 7, 8, 9, and 10
  

• Global functioning as assessed by Clinical Global Impression of Severity and Clinical Global Impression of Change at baseline and weeks 1, 3, 4, 5, 7, 8, 9, and 10
  

OBJECTIVES:

• Compare the effectiveness of low-dose vs high-dose modafinil for treatment of fatigue and neurobehavioral dysfunction in patients with primary brain tumors.
• Determine the safety of this drug in these patients.
• Compare quality of life of patients treated with 2 different doses of this drug.

OUTLINE: This is a randomized, double-blind, parallel-group study. Patients are randomized to 1 of 2 arms.

• Randomized phase:

  • Arm I: Patients receive oral high-dose modafinil twice daily.
  • Arm II: Patients receive oral low-dose modafinil twice daily. In both arms, treatment in this phase continues for 3 weeks followed by a 1-week washout period.
• Extended treatment phase:After the 1-week washout period, all patients receive oral low-dose modafinil once daily on days 1-3. The dose is then titrated to an optimal level and administered in divided doses.

Fatigue, neurobehavioral dysfunction, and quality of life are assessed during the randomized phase at baseline and on days 7 and 21 and then during the extended treatment phase at baseline and on days 28 and 56.

PROJECTED ACCRUAL: Approximately 30 patients will be accrued for this study.

DISEASE CHARACTERISTICS:

• Diagnosis of primary malignant brain tumor and receiving treatment in the UCLA Neuro-Oncology Program

  • Nonmalignant cerebral tumors also allowed
• Received some combination of prior therapy for disease, including neurosurgical resection, radiotherapy, and cytotoxic or cytostatic chemotherapy
• Mild to severe fatigue and/or attention/memory impairment, as measured by the Clinical Global Impression of Severity Scale

PATIENT CHARACTERISTICS:

Age

• 21 to 65

Performance status

• Not specified

Life expectancy

• Not specified

Hematopoietic

• Not specified

Hepatic

• Bilirubin no greater than 2.5 times normal
• SGOT no greater than 2.5 times normal

Renal

• Creatinine no greater than 1.5 mg/dL

Other

• Able to speak English
• Capable of completing self-rating scales and one-on-one psychometric tests
• No severe cognitive impairment
• No other terminal illness
• No emergency patients
• No institutional residents
• No prisoners or parolees
• No UCLA students or staff
• Not pregnant or nursing
• Negative pregnancy test
• Fertile patients must use effective contraception

PRIOR CONCURRENT THERAPY:

Biologic therapy

• Not specified

Chemotherapy

• See Disease Characteristics
• No concurrent irinotecan
• No concurrent participation in UCLA experimental chemotherapy trials
• Concurrent conventional chemotherapy (e.g., carboplatin, lomustine, temozolomide) allowed

Endocrine therapy

• Concurrent glucocorticoids (e.g., dexamethasone) allowed
• Concurrent tamoxifen allowed

Radiotherapy

• See Disease Characteristics

Surgery

• See Disease Characteristics

Other

• No prior modafinil
• At least 30 days since prior stimulants (e.g., amphetamines or methylphenidate)
• No concurrent experimental anticancer medication
• No concurrent tricyclic antidepressants and/or monoamine oxidase inhibitors
• Concurrent anticonvulsants allowed
• Concurrent isotretinoin allowed