Modafinil in Treating Fatigue and Behavioral Change in Patients With Primary Brain Cancer

• Status: Completed
• Trial end date: 2010-08-01
• Target enrollment: 0
• Participant gender: All

Summary

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: This randomized clinical trial is comparing how well two different doses of modafinil work in treating fatigue and behavioral changes in patients who have undergone treatment for primary brain cancer.

• Phase: N/A
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Jonsson Comprehensive Cancer Center
• Collaborators: Cephalon; National Cancer Institute (NCI)
• Treatments: Armodafinil; Modafinil

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