Modafinil in Treating Fatigue and Behavioral Change in Patients With Primary Brain Cancer
Brain and Central Nervous System Tumors, Cognitive/Functional Effects, Fatigue
About this trial
This is an interventional supportive care trial for Brain and Central Nervous System Tumors focused on measuring adult brain tumor, fatigue, cognitive/functional effects
Eligibility Criteria
Inclusion Criteria: 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 Age 21 to 65 Able to speak English Capable of completing self-rating scales and one-on-one psychometric tests Negative pregnancy test Fertile patients must use effective contraception Concurrent conventional chemotherapy (e.g., carboplatin, lomustine, temozolomide) allowed Concurrent glucocorticoids (e.g., dexamethasone) allowed Concurrent tamoxifen allowed At least 30 days since prior stimulants (e.g., amphetamines or methylphenidate) Concurrent anticonvulsants allowed Concurrent isotretinoin allowed Exclusion Criteria: Have significant hepatic disease, defined as SGOT greater than or equal to 2.5 times the upper limit of normal. Have significant renal disease, defined as creatinine greater than or equal to 1.5mg/dl. severe cognitive impairment other terminal illness emergency patient institutional resident prisoner or parolee UCLA students or staff pregnant or nursing concurrent irinotecan concurrent participation in UCLA experimental chemotherapy trials prior modafinil concurrent experimental anticancer medication concurrent tricyclic antidepressants and/or monoamine oxidase inhibitors
Sites / Locations
- Jonsson Comprehensive Cancer Center at UCLA
Arms of the Study
Arm 1
Arm 2
Experimental
Experimental
drug dosage 1
drug dosage 2
- Arm I: Patients receive oral high-dose modafinil twice daily.
- Arm II: Patients receive oral low-dose modafinil twice daily.