This is a phase II single-arm, Phase 2a, randomized, double-blinded, placebo-controlled pilot clinical trial determining efficacy of riluzole in preventing cognitive dysfunction in subjects with cancer, who are receiving chemotherapy.
Female and male patients diagnosed with cancer and planned to receive an anthracycline- or platinum- containing chemotherapy regimen.
≥18 years of age.
Life expectancy > 6 months
Able to provide informed consent.
Presence of primary brain tumors or brain metastases.
Receive a primary chemotherapy regimen that does not include anthracycline- or platinum- containing chemotherapy.
Unwilling to undergo neuropsychological assessments necessary for the study.
Patients who are breastfeeding, pregnant or are planning to get pregnant during the study period. POCBP must have a negative pregnancy test at screening if there is suspicion of pregnancy. Patients who are considered not to be of childbearing potential must have a history of being postmenopausal (with a minimum of 1 year without menses), tubal ligation, or hysterectomy.
University of California, Irvine
Lead sponsor