Open Label Safety Study of Solriamfetol to Promote Wakefulness and Improve Cognition and Quality of Life in Patients With Primary Gliomas

⁃ WHO Grade 2-4 infiltrating glioma by histologic confirmation

• Where appropriate results from clinically available testing of isocitrate dehydrogenase (IDH) gene mutation status (for all gliomas), chromosome 1p and 19q deletion status (for suspected oligodendrogliomas), and MGMT gene promoter methylation status (for malignant gliomas) must be available in the patient's chart.

• These studies are standard of care molecular studies that are performed as a part of routine clinical practice and allow for integrated molecular subtyping of primary glial tumors.

⁃ Epworth Sleepiness Scale (ESS) score \>10 within 21 days of enrollment

⁃ Clinical and/or radiographic evidence of stable disease within 21 days of enrollment

• Patients must have completed concurrent chemoradiation with recovery of all pre-existing toxicity to CTCAE Grade \>1

• Patient who are anticipated to undergo surgery and/or radiation therapy for management of their tumor during the duration of study treatment are NOT eligible.

• Patients who are anticipated to undergo adjuvant chemotherapy are eligible as long as there is no evidence of tumor progression by clinical exam and/or imaging within 21 days of enrollment (see 4.1.2). This determination should be made by clinical documentation and if there is question discussed with the Study Chair. Adjuvant chemotherapy is not an exclusion.

• Patients who are currently undergoing chemotherapy, targeted therapy, immunotherapy, or salvage treatment and have stable disease by imaging are eligible and can continue the current anti-cancer therapy. Patients who will require a new anti-cancer treatment or are anticipated to change anti-cancer treatments are not eligible.

⁃ Age \> 18 years

⁃ Karnofsky performance status ≥ 60%

⁃ Life expectancy of greater than 4 months

⁃ Patients must have normal organ and marrow function as defined below:

⁃ leukocytes \>3,000/mcL absolute neutrophil count \>1,500/mcL platelets \>100,000/mcL total bilirubin 1.5 X institutional upper limits of normal AST(SGOT)/ALT(SGPT) \<2.5 X institutional upper limit of normal creatinine within normal institutional limits OR creatinine clearance \>50 mL/min/1.73 m2 for patients with creatinine levels above institutional normal.

• The effects of solriamfetol on the developing human fetus are unknown. For this reason women of child-bearing potential and men must agree to use adequate contraception (hormonal or barrier method of birth control; abstinence) prior to study entry and for the duration of study participation. Should a woman become pregnant or suspect she is pregnant while participating in this study, she should inform her treating physician immediately

• Ability to understand and the willingness to sign an IRB-approved informed consent document (either directly or via a legally authorized representative)