RATIONALE: Modafinil may be effective in relieving fatigue and improving behavioral changes such as memory loss in patients who have undergone treatment for primary brain cancer. The effectiveness of modafinil in relieving fatigue and improving behavioral change is not yet known.

PURPOSE: Randomized clinical trial to determine the effectiveness of modafinil in treating fatigue and behavioral changes in patients who have undergone treatment for primary brain cancer.

Condition	Treatment or Intervention
adult brain tumor Fatigue cognitive/functional effects	Drug: modafinil  Procedure: cognitive assessment  Procedure: complications of therapy assessment/management  Procedure: fatigue assessment/management  Procedure: supportive care/therapy

Further Study Details: 

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.

• Arm I: Patients receive oral high-dose modafinil twice daily.
• 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.

Ages Eligible for Study:  21 Years   -   65 Years,  Genders Eligible for Study:  Both

Criteria

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 upper limit of normal (ULN)
• SGOT no greater than 2.5 times ULN

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

California
      Jonsson Comprehensive Cancer Center, UCLA, Los Angeles,  California,  90095-6967,  United States; Recruiting

Study chairs or principal investigators

Thomas A. Kaleita, PhD,  Principal Investigator,  Jonsson Comprehensive Cancer Center   

Study ID Numbers:  CDR0000258139; UCLA-0206017; CEPHALON-UCLA-0206017; NCI-G02-2133; NCT00052286
Record last reviewed:  October 2004
Last Updated:  December 6, 2004
Record first received:  January 24, 2003
ClinicalTrials.gov Identifier:  NCT00052286
Health Authority: United States: Federal Government
ClinicalTrials.gov processed this record on 2005-04-08